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• trial_statuses(array)
  • 1Recruiting
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• applications(array)
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      • id1482
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      • trial_status_id(null)
      • abstract_of_study<p>\n <strong><u>Trial Design</u></strong>:</p>\n<p>\n This is a Phase III multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of crizanlizumab 5 mg/kg versus placebo, with or without concurrent HU/HC therapy in patients with SCD who experience frequent VOCs (4-12 events in the 12 months prior to the screening visit).</p>\n<p>\n  </p>\n<p>\n <strong><u>Purpose of the study:</u></strong></p>\n<p>\n The main purpose of this study is to determine whether crizanlizumab may reduce the number of VOCs when compared to placebo, with or without standard of care medications in adolescent and adult SCD patients with frequent VOCs leading to healthcare visits. The study duration will be approximately 2 years.</p>\n<p>\n  </p>\n<p>\n <strong><u>Study Rationale:</u></strong></p>\n<p>\n Crizanlizumab was first approved in the USA (BLA 761128) under the trade name Adakveo® on 15-Nov-2019. This BLA approval was based on the results from the Phase II Study CSEG101A2201 (SUSTAIN), a 52-week, randomized, placebo-controlled study (N=198) of crizanlizumab 2.5 and 5 mg/kg. In Study A2201, a vasoocclusive crises (VOC) was defined as an acute episode of pain with no other cause than a vasoocclusion, which required a visit to a medical facility and treatment with oral or parenteral opioids or parenteral non-steroidal anti-inflammatory drugs (NSAIDs). This included both uncomplicated VOCs as well as complicated VOCs such as acute chest syndrome, hepatic sequestration, splenic sequestration, and priapism. These visits required a visit to a medical facility. An uncomplicated crisis was defined as a VOC that was not classified as acute chest syndrome, hepatic sequestration, splenic sequestration, priapism, and which did not lead to death.</p>\n<p>\n  </p>\n<p>\n Treatment with crizanlizumab 5 mg/kg in Study A2201 resulted in a median annual rate of VOCs leading to a healthcare visit that was 45.3% lower than the median annual rate with placebo, which was statistically significant (p=0.010). The</p>\n<p>\n median annual rate of uncomplicated crises and median number of days hospitalized were 62.9% and 41.8% lower than in the placebo group, respectively. These constitute meaningful reductions in the frequency of VOCs and hospitalizations that can be expected to have a significant impact on quality of life (QoL), morbidity and mortality in patients with SCD.</p>\n<p>\n  </p>\n<p>\n Study CSEG101A2301 is an ongoing Phase III, multicenter, randomized, double-blind study to assess efficacy and safety of two doses of crizanlizumab (5 mg/kg and 7.5 mg/kg) versus placebo, with or without hydroxyurea/ hydroxycarbamide therapy (HU/HC), in adolescent and adult patients with SCD. VOC was defined the same way as previously noted in the SUSTAIN trial.</p>\n<p>\n  </p>\n<p>\n In Dec-2022, the results of the primary analysis of Study CSEG101A2301 did not show evidence of superiority of either dose of crizanlizumab (5 mg/kg or 7.5 mg/kg) over placebo on the primary or key secondary endpoints, and therefore are not consistent with the results from Study CSEG101A2201.</p>\n<p>\n  </p>\n<p>\n While the endpoint of VOC leading to a healthcare visit reflects a key aim of treatment in SCD, i.e., prevention/reduction of VOCs, it is important to note that it is dependent on patients making the decision to go or not go to the hospital. The different results in Study CSEG101A2301 compared with Study CSEG101A2201 could be due to various factors/differences between the studies, including but not limited to:</p>\n<p>\n  </p>\n<p>\n • The impact of the COVID-19 global pandemic, which may have caused a masking effect/reduction in reporting of VOCs as well as a potential reduction in triggers for VOCs in Study CSEG101A2301.</p>\n<p>\n • Differences in the geographic location of participating patients, thereby factoring in the differences in healthcare utilization: patients were located primarily in the USA in Study CSEG101A2201 vs. globally dispersed in Study CSEG101A2301.</p>\n<p>\n  </p>\n<p>\n Thus, while the initial randomized, placebo-controlled trial (Study CSEG101A2201), the open label studies (Study SEG101A2202, Study SEG101B2201 and Study SEG101AUS05) and real-world data (MAP data and registries) have all demonstrated clinical benefit with crizanlizumab, the second, randomized, placebo-controlled Study CSEG101A2301 did not.</p>\n<p>\n The current study (Study CSEG101A2303; hereafter referred to as Study A2303), a randomized, placebo-controlled Phase III study, was developed to overcome the uncertainties raised by the conflicting results of Studies CSEG101A2301 and CSEG101A2201. The purpose of this study is to compare the efficacy of crizanlizumab (5 mg/kg) versus placebo, with or without HU/HC in adolescent and adult SCD patients with frequent VOCs (4 to 12 per year) that are Health care practitioner-managed (including VOCs leading to management at a health care facility or those managed via remote consultation).</p>\n<p>\n Data from this study will be used to evaluate the effect of crizanlizumab versus placebo, with or without concurrent HU/HC therapy, on VOC rate in SCD patients aged 12 years and older who experience frequent VOCs.</p>\n<p>\n  </p>\n<p>\n <strong>Study Population:</strong></p>\n<p>\n The study will include participants aged 12 years and older with confirmed diagnosis of SCD (all genotypes are eligible) who have experienced at least 4-12 VOCs that are HCP-managed (including VOCs leading to management at a health care facility or those managed via remote consultation) within the 12 months prior to the screening visit. Participants may receive HU/HC as a standard of care.</p>\n<p>\n This study plans to enroll 315 participants. Participants will be randomized in a 2:1 ratio to the crizanlizumab 5 mg/kg or placebo treatment arm (see Section 9.9 of the Protocol v00 for more details on sample size determination).</p>\n<p>\n  </p>\n
      • study_title<p>\n A phase III, Multicenter, Randomized, Placebo Controlled, Double blind Study to Assess Efficacy and Safety of Crizanlizumab (5 mg/kg) versus placebo, with or without Hydroxyurea/Hydroxycarbamide Therapy, in Adolescent and Adult Sickle Cell Disease Patients with Frequent Vaso-Occlusive Crises</p>\n
      • laymans_summary<p>\n Sickle cell disease (SCD) is a serious and life-threatening inherited blood disorder. Sickle cell disease affects millions of people worldwide and is very common in certain areas of Africa. In Kenya alone, approximately 14,000 children are born with sickle cell disease each year and 21 out of 100 children in Kisumu are born with Sickle cell trait. This chronic disease touches numerous regions within Kenya, with Western, Nyanza, and Coastal areas particularly burdened, affecting 17 counties. Moreover, the phenomenon of migration and intermarriage has led to an increasing prevalence of the condition in other regions of the country.</p>\n<p>\n  </p>\n<p>\n Although there are advances in the medical management of patients with sickle cell disease, patients continue to suffer significantly from the disease which is characterized by severe intense pain also called vaso-occlusive crisis (VOCs) that progresses into acute disease, organ failure and untimely death. Previous studies have shown that pain rate increases from early childhood to young adulthood and patients with SCD who experience multiple documented painful crises and anaemia are at risk for early death. The current study seeks to establish the how successful and how well a drug called crizanlizumab works by assessing the yearly rate of occurrence of painful crises that are attended to by healthcare professionals (HCP) over the planned 52-week treatment period in SCD patients aged 12 years and older with a history of frequent VOCs.</p>\n<p>\n  </p>\n<p>\n The study will be conducted by Victoria Biomedical Research Institute (VIBRI) at the Kisumu County Referral Hospital and Rachuonyo County Hospital. The study will enroll participants aged 12 years and older with confirmed diagnosis of SCD who have experienced at least 4-12 painful crises (VOCs) that are attended to by HCP (including VOCs leading to management at a health care facility or those managed via remote consultation) within the 12 months prior to the screening visit. A total of 315 participants who qualify for the study after consenting to participate and undergoing screening will be enrolled to receive the study drug and they will be monitored over a one-year period to ensure their safety and determine how successful the drug is. The VIBRI site plans to enrol about 60 SCD patients into the study as participants out of the total number required worldwide.</p>\n<p>\n  </p>\n<p>\n The results of this study will be used to determine how to use this drug in future among patients with sickle cell disease.</p>\n
      • short_titleSparkle
      • protocol_noECCT/24/11/01
      • version_no00
      • date_of_protocol02-02-2024
      • study_drugCrizanlizumab
      • disease_conditionSickle cell disease
      • product_type_biologicals1
      • product_type_proteins0
      • product_type_immunologicals1
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical0
      • product_type_medical_device0
      • product_type_chemical_name
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressraps.clinicaltrials@novartis.com
      • applicant_covering_letter1
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      • applicant_impd0
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      • applicant_pictorial_sample0
      • applicant_gcp_training1
      • applicant_dsmb_charter0
      • applicant_detailed_budget0
      • applicant_indemnity_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
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      • statistical_analysis_plan1
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      • declaration_applicantDenish Maisiba
      • declaration_date113-11-2024
      • declaration_principal_investigatorDr Lucas Otieno Tina
      • declaration_date213-11-2024
      • placebo_presentYes
      • study_objectives<p>\n <strong><u>Primary Objective:</u></strong></p>\n<p>\n To compare the efficacy of 5 mg/kg of crizanlizumab versus placebo, with or without hydroxyurea/hydroxycarbamide, on the annualized rate of VOCs* that are HCPmanaged (including VOCs leading to management at a health care facility or those managed via remote consultation) over the planned 52-week treatment period in SCD patients aged 12 years and older with a history of frequent VOCs (4-12 events in 12 months prior to the screening visit).</p>\n<p>\n  </p>\n<p>\n <strong><u>Secondary Objective:</u></strong></p>\n<p>\n To compare the efficacy of 5 mg/kg of crizanlizumab versus placebo, with or without hydroxyurea/hydroxycarbamide, on the annualized rate of all VOCs including VOCs that are HCP-managed (including VOCs leading to management at a health care facility or those managed via remote consultation) and VOCs that are self-managed without recommendations from HCP during the event over the planned 52- week treatment period in SCD patients aged 12 years and older with a history of frequent VOCs (4-12 events in the 12 months prior to the screening visit).</p>\n<p>\n  </p>\n<p>\n To evaluate the annualized rate of VOCs by type of management between treatment arms over the planned 52-week treatment period:</p>\n<p>\n  </p>\n<p>\n ·         VOCs that are HCP-managed at a health care facility</p>\n<p>\n ·         VOCs that are HCP-managed via remote consultation</p>\n<p>\n ·         VOCs that are self-managed without recommendations from HCP during the event</p>\n<p>\n ·         VOCs that are HCP-managed via remote consultation or self-managed without recommendations from HCP during the event</p>\n<p>\n  </p>\n<p>\n To evaluate the time to first VOC that is HCPmanaged (including VOCs leading to management at a health care facility or those managed via remote consultation) between treatment arms over the planned 52-week treatment period.</p>\n<p>\n  </p>\n<p>\n To evaluate the proportion of participants free from VOCs that are HCP-managed (including VOCs leading to management at a health care facility or those managed via remote consultation) between treatment arms over the planned 52-week treatment period.</p>\n<p>\n  </p>\n<p>\n To evaluate the duration of VOCs that are HCP managed (including VOCs leading to management at a health care facility or those managed via remote consultation) between treatment arms over the planned 52-week treatment period.</p>\n<p>\n  </p>\n<p>\n To evaluate the safety and immunogenicity of crizanlizumab 5 mg/kg over the 2-year study period.</p>\n<p>\n  </p>\n<p>\n <strong><u>Exploratory Objectives:</u></strong></p>\n<p>\n To explore the efficacy of crizanlizumab 5 mg/kg over the 2-year study period.</p>\n<p>\n  </p>\n<p>\n To explore the proportion of VOCs that are self-managed without recommendations from HCP during the event, versus VOCs that are HCP managed (including VOCs leading to management at a health care facility or those managed via remote consultation) between treatment arms over the planned treatment period of 52 weeks.</p>\n<p>\n  </p>\n<p>\n To explore the proportion of VOCs that are HCP managed via remote consultation versus VOCs that are HCP-managed at a healthcare facility between treatment arms over the planned 52- week treatment period.</p>\n<p>\n  </p>\n<p>\n To explore the incidence rates of all VOCs, VOCs that are HCP-managed at a healthcare facility, VOCs that are HCP-managed via remote consultation, VOCs that are HCP-managed, VOCs that are self-managed without recommendations from HCP during the event, VOCs that are HCP-managed via remote consultation or self-managed without recommendations from HCP during the event, by treatment arm.</p>\n<p>\n  </p>\n<p>\n To explore quality of life in each treatment arm (ASCQ-Me Short Forms: emotional impact, sleep impact, and joint stiffness).</p>\n<p>\n  </p>\n<p>\n To explore healthcare facility resource utilization (inpatient hospital admission, emergency room visit, urgent care/clinic visit, infusion center visit) between treatment arms over the planned 52- week treatment period.</p>\n<p>\n  </p>\n<p>\n To explore the pharmacokinetics (PK) profile of crizanlizumab at 5 mg/kg.</p>\n<p>\n  </p>\n<p>\n To explore the pharmacodynamics (PD) (P selectin inhibition) of crizanlizumab at 5 mg/kg.</p>\n<p>\n  </p>\n<p>\n To explore biomarkers [p-selectin (free and total)] and CRP].</p>\n<p>\n  </p>\n<p>\n To explore exposure-response relationship.</p>\n<p>\n  </p>\n
      • principal_inclusion_criteria<p>\n <strong><u>Principal Inclusion Criteria:</u></strong></p>\n<p>\n 1. Signed informed consent must be obtained prior to participation in the study.</p>\n<p>\n 2. Participants must be aged 12 years and older on the day of signing informed consent. Adolescents include participants aged 12 to <18 years old and adults include participants aged 18 years and older.</p>\n<p>\n 3. Confirmed diagnosis of SCD by Hb electrophoresis or high-performance liquid chromatography (HPLC) (performed locally or by central laboratory if not available locally). All SCD genotypes are eligible.</p>\n<p>\n 4. Experienced 4 to 12 VOCs that are HCP-managed (including VOCs leading to management at a health care facility or those managed via remote consultation) within the 12 months prior to the screening visit. Baseline VOCs are determined by medical history and are required to be documented at source.</p>\n<p>\n Prior VOCs that were HCP-managed at a health care facility or managed via remote consultation must have resolved at least 7 days prior to Week 1 Day 1 dosing.</p>\n<p>\n 5. If the participant is on HU/HC, they must be taking it for at least 6 months and at stable dose for at least 3 months prior to the Screening visit and plan to continue taking it at the same dose and schedule until at least the participant has reached 52 weeks of the planned study treatment. Participants who have initiated HU/HC 6-12 months prior to the screening visit must have evidence of insufficient control of acute pain despite initiation. These participants must have a cumulative of 4-12 VOCs in the 12 months prior to the screening period, with at least 2 during the last 6 months while on HU/HC. If receiving erythropoietin stimulating agent, the participant must have been receiving the drug for at least 6 months prior to screening visit and plan to continue taking the drug at the same dose and schedule until the participant has reached 52 weeks of the planned study treatment.</p>\n<p>\n  </p>\n<p>\n Participants who have not been receiving HU/HC, and/or erythropoietin stimulating agent must not have received it for at least 6 months prior to screening visit.</p>\n<p>\n 6. Participants must meet the following central laboratory values prior to Week1 Day 1. In case re-sampling is needed, local laboratory values are allowed.</p>\n<p style=\"margin-left:.2in;\">\n • Absolute Neutrophil Count ≥1.0 x 109/L</p>\n<p style=\"margin-left:.2in;\">\n • Platelet count ≥75 x 109/L</p>\n<p style=\"margin-left:.2in;\">\n • Hemoglobin: for adults (Hb) ≥5.0 g/dL and for adolescents (Hb) ≥5.5 g/dL</p>\n<p style=\"margin-left:.2in;\">\n • Glomerular filtration rate ≥45 mL/min/1.73 m2 based on CKD-EPI formula (patients ≥18), or the Creatinine-based “Bedside Schwartz” equation (patients <18)</p>\n<p style=\"margin-left:.2in;\">\n • Direct (conjugated) bilirubin ≤3.0 x ULN</p>\n<p style=\"margin-left:.2in;\">\n • Alanine transaminase (ALT) <3.0 x ULN</p>\n<p>\n 7. Score of 50% or higher on the Karnofsky Performance Scale at screening.</p>\n<p>\n 8. Received standard age-appropriate care for SCD, including an up-to-date record of immunizations, as per local requirements.</p>\n
      • principal_exclusion_criteria<p>\n <strong><u>Principal Exclusion Criteria:</u></strong></p>\n<p>\n Participants meeting any of the following criteria are not eligible for inclusion in this study.</p>\n<p>\n 1. Fewer than 4 or more than 12 VOCs that are HCP-managed (including VOCs leading to management at a health care facility or those managed via remote consultation) within the 12 months prior to screening visit as determined by medical history and documented at source.</p>\n<p>\n 2. History of stem cell transplant and/or gene therapy.</p>\n<p>\n 3. Received blood products within 30 days prior to Week 1 Day 1 dosing.</p>\n<p>\n 4. Any documented history of a clinical stroke or intracranial hemorrhage, or an uninvestigated neurologic finding within the past 12 months before screening visit. Silent infarct only present on imaging is not excluded.</p>\n<p>\n 5. Clinically significant bleeding disorder.</p>\n<p>\n 6. Use of therapeutic anticoagulation or antiplatelet therapy (other than aspirin or NSAIDs) within the 10 days prior to Week 1 Day 1 dosing. Note: Prophylactic anticoagulant dose is permitted, as per local guidelines.</p>\n<p>\n 7. Participating in a chronic transfusion program (pre-planned series of transfusions for prophylactic purposes) and/or planning to undergo an exchange transfusion during the duration of the study; episodic transfusion in response to worsened anemia or VOC is permitted.</p>\n<p>\n 8. Contraindication or hypersensitivity to any drug or metabolites from similar class as study drug or to any excipients of the study drug formulation. History of severe hypersensitivity reaction to other monoclonal antibodies, which in the opinion of the investigator may pose an increased risk of serious infusion reaction.</p>\n<p>\n 9. Received active treatment on another investigational trial within 30 days (or 5 half-lives of that agent, whichever is greater) prior to Screening visit or plans to participate in another investigational drug trial.</p>\n<p>\n 10. Participants of child-bearing potential who are or might become sexually active, must be informed of the potential teratogenic risk with crizanlizumab and the need for highly effective contraception methods to prevent pregnancy while on crizanlizumab therapy. Any participant with the biologic potential to become pregnant must agree to the use of oral, injected or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS) or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception is required if sexually active. Patients should also follow other guidelines for contraception in the setting of other standard of care therapies. Contraception must be used during the study and for 15 weeks after stopping treatment. The decision on the contraceptive method should be reviewed at least every 3 months to evaluate the individual need and compatibility of the method chosen.</p>\n<p>\n 11. Pregnant females or females who have given birth within the past 90 days or who are breastfeeding.</p>\n<p>\n 12. Planning to undergo a major surgical procedure during the duration of the study.</p>\n<p>\n 13. Hospitalized within 7 days prior to Week 1 Day 1 dosing.</p>\n<p>\n 14. Acute VOCs ending within 7 days prior to Week 1 Day 1 dosing.</p>\n<p>\n 15. Participants with active HIV infection (detectable viral load) at screening.</p>\n<p>\n 16. Participants with active Hepatitis B infection (HBsAg positive) at screening. Note: Participants with antecedent but no active Hepatitis B (i.e., anti-HBs positive, HBsAg and HBV-DNA negative) are eligible.</p>\n<p>\n 17. Positive test for hepatitis C ribonucleic acid (HCV RNA) at screening. Note: Participants in whom HCV infection resolved spontaneously (positive HCV antibodies without detectable HCV-RNA) or those that achieved a sustained virological response after antiviral treatment and show absence of detectable HCV RNA ≥6 months (with the use of IFN-free regimes) or ≥12 months (with the use of IFN-based regimes) after cessation of antiviral treatment are eligible.</p>\n<p>\n 18. Malignant disease. Exceptions to this exclusion include the following: malignancies that were treated curatively and have not recurred within 3 years prior to study treatment; completely resected basal cell and squamous cell skin cancers and any completely resected carcinoma in situ.</p>\n<p>\n 19. Concurrent severe and/or uncontrolled medical conditions which, in the opinion of the investigator, could cause unacceptable safety risks or compromise participation in the study.</p>\n<p>\n 20. Any condition which, in the opinion of the investigator, is likely to interfere with the successful collection of the measurements required for the study. This can include inability to understand and comply with study instructions and requirements.</p>\n<p>\n 21. Received prior treatment with crizanlizumab or other selectin targeting agent or plans to receive these therapies outside of the study during the duration of the study.</p>\n<p>\n 22. Use of HA approved form(s) of L-glutamine within 6 months of screening or plans to receive it during the study.</p>\n<p>\n 23. Currently on voxelotor or received voxelotor within 6 months of screening or plans to receive it during the study.</p>\n<p>\n 24. Participants taking prohibited therapies</p>\n
      • primary_end_points<p>\n <strong><u>Primary Endpoint:</u></strong></p>\n<p>\n Annualized rate of VOCs that are HCPmanaged (including VOCs leading to management at a health care facility or those managed via remote consultation) in each treatment arm over the planned 52-week treatment period</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic1
      • scope_pharmacodynamic1
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic1
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory1
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n <strong><u>Site 1401:</u></strong></p>\n<p>\n VIBRI has over 100 members of staff who are delegated and involved in clinical research studies including investigators, study coordinators, clinicians, nurses, laboratory technologists, pharmacists, data clerks, field assistants and administrative staff. This study will involve 8 investigators, and at least 2 study Coordinators, 2 pharmacists, 6 laboratory technologists among other cadres of staff.</p>\n<p>\n The site has a well-furnished and equipped offices with controlled access, computers, internet access, telephone connections, photocopiers, and scanners and monitoring rooms.</p>\n<p>\n  </p>\n<p>\n VIBRI is located near both private and public referral health facilities, which operate 24 hours a day. The site is equipped with an emergency 2 crash cart, and the clinical team have received training in Basic Life support (BLS) and advanced cardiac life support (ACLS)to handle emergency at site before referral to appropriate health facility in case of emergency.</p>\n<p>\n There are 4 -80<span dir=\"RTL\">ï¹¾</span>C, storage freezers, 4 -20<span dir=\"RTL\">ï¹¾</span>C, 4 refrigerated centrifuges, 2 incubators, 3 biosafety hoods, chemistry and hematology analysers, temperature data loggers among other equipment. The pharmacy is equipped with cold chain capacity and investigational product preparation equipment including: two 2-8<span dir=\"RTL\">ï¹¾</span>C vaccine refrigerators, 2 -20<span dir=\"RTL\">ï¹¾</span>C freezers, with data loggers for temperature monitoring, biosafety hoods for investigational product preparation, computers, printers among other equipment.</p>\n<p>\n  </p>\n
      • other_details_explanation<p>\n Switzerland is the host country of the Sponsor however the study will not be conducted in the host country because the birth incidence of disease is far lower in Switzerland than in Kenya.</p>\n
      • other_details_regulatory_notapproved<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\">\n <tbody>\n <tr>\n <td style=\"width:160px;\">\n <p align=\"center\">\n <strong>Country</strong></p>\n </td>\n <td style=\"width:160px;\">\n <p align=\"center\">\n <strong>Agency</strong></p>\n </td>\n <td style=\"width:160px;\">\n <p align=\"center\">\n <strong>HA submission Date</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:160px;\">\n <p align=\"center\">\n Brazil</p>\n </td>\n <td style=\"width:160px;\">\n <p align=\"center\">\n Agência Nacional de Vigilância Sanitária  - ANVISA</p>\n </td>\n <td style=\"width:160px;\">\n <p align=\"center\">\n 10-May-2024</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:160px;\">\n <p align=\"center\">\n Colombia</p>\n </td>\n <td style=\"width:160px;\">\n <p align=\"center\">\n Instituto de Vigilancia de Medicamentos y Alimentos INVIMA</p>\n </td>\n <td style=\"width:160px;\">\n <p align=\"center\">\n 09-Jul-2024</p>\n </td>\n </tr>\n </tbody>\n</table>\n<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\">\n <tbody>\n <tr>\n <td style=\"width:160px;\">\n <p align=\"center\">\n <strong>Country</strong></p>\n </td>\n <td style=\"width:160px;\">\n <p align=\"center\">\n <strong>Agency</strong></p>\n </td>\n <td style=\"width:160px;\">\n <p align=\"center\">\n <strong>HA submission Date</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:160px;\">\n <p>\n Brazil</p>\n </td>\n <td style=\"width:160px;\">\n <p>\n Agência Nacional de Vigilância Sanitária  - ANVISA</p>\n </td>\n <td style=\"width:160px;\">\n <p>\n 10-May-2024</p>\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:160px;\">\n <p>\n Colombia</p>\n </td>\n <td style=\"width:160px;\">\n <p>\n Instituto de Vigilancia de Medicamentos y Alimentos INVIMA</p>\n </td>\n <td style=\"width:160px;\">\n <p>\n 09-Jul-2024</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:160px;\">\n <p>\n Ghana</p>\n </td>\n <td style=\"width:160px;\">\n <p>\n Food and Drug Authority (FDA) Ghana</p>\n </td>\n <td style=\"width:160px;\">\n <p>\n Planned</p>\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:160px;\">\n <p>\n Kenya</p>\n </td>\n <td style=\"width:160px;\">\n <p>\n Pharmacy and Poisons Board (PPB)  </p>\n </td>\n <td style=\"width:160px;\">\n <p>\n Planned</p>\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:160px;\">\n <p>\n Nigeria</p>\n </td>\n <td style=\"width:160px;\">\n <p>\n National Agency for Food and Drug Administration and Control</p>\n </td>\n <td style=\"width:160px;\">\n <p>\n Planned</p>\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:160px;\">\n <p>\n Tanzania</p>\n </td>\n <td style=\"width:160px;\">\n <p>\n TANZANIA MEDICINES AND MEDICAL DEVICES AUTHORITY (TMDA)</p>\n </td>\n <td style=\"width:160px;\">\n <p>\n Planned</p>\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:160px;\">\n <p>\n Uganda</p>\n </td>\n <td style=\"width:160px;\">\n <p>\n National Drug Authority (NDA)</p>\n </td>\n <td style=\"width:160px;\">\n <p>\n Planned</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:160px;\">\n <p>\n Zambia</p>\n </td>\n <td style=\"width:160px;\">\n <p>\n Zambia Medicines Regulatory Authority ZAMRA</p>\n <p>\n  </p>\n </td>\n <td style=\"width:160px;\">\n <p>\n Planned</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:160px;\">\n <p>\n United States</p>\n </td>\n <td style=\"width:160px;\">\n <p>\n U.S. Food and Drug Administration</p>\n </td>\n <td style=\"width:160px;\">\n <p>\n 06-Mar-2024</p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n
      • other_details_regulatory_approved<p>\n United States – Silent Approval</p>\n
      • other_details_regulatory_rejected<p>\n No Rejections received to date.</p>\n
      • other_details_regulatory_halted<p>\n Not applicable</p>\n
      • estimated_durationapproximately 2 years
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindNo
      • design_controlled_double_blindYes
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorNot applicable
      • design_controlled_other_medicinalNo
      • design_controlled_placeboYes
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesYes
      • multiple_member_states9
      • number_of_sites6
      • multi_country_listBrazil\nColombia\nGhana, \nKenya\nNigeria\nUganda\nTanzania\nZambia\nUnited State\n
      • data_monitoring_committeeNo
      • total_enrolment_per_siteMin 5 maximum 15 across 6 sites
      • total_participants_worldwide315
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentYes
      • population_above_18Yes
      • population_adultYes
      • population_elderlyYes
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameLucas
      • investigator1_middle_nameOtieno
      • investigator1_family_nameTina
      • investigator1_qualificationlucas.tina0818@gmail.com, Itina@vibriafrica.org
      • investigator1_professional_addressVictoria Biomedical Research Institute, Kisumu County Referral Hospital P.O. Box 7180, Postal Code 40100, Kisumu, Kenya
      • investigator1_telephone+254720597654
      • investigator1_emailItina@vibriafrica.org
      • organisations_transferred_Yes
      • number_participants60
      • notification
      • approval_date13-05-2025
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted13-11-2024
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonReviewer comments have been addressed.
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2025-05-13 11:11:08
      • created2024-11-12 15:06:59
      • total_sites6
      • ecitizen_invoice328874
    • InvestigatorContact(array)
      • 0(array)
        • id1182
        • application_id1482
        • given_nameLucas
        • middle_nameOtieno
        • family_nameTina
        • qualificationlucas.tina0818@gmail.com, Itina@vibriafrica.org
        • professional_addressia Biomedical Research Institute, Kisumu County Referral Hospital P.O. Box 7180, Postal Code 40100, Kisumu, Kenya
        • telephone+254720597654
        • emailItina@vibriafrica.org
        • created2024-11-12 16:45:07
        • modified2024-11-13 17:15:45
    • SiteDetail(array)
      • 0(array)
        • id1813
        • application_id1482
        • county_id42
        • site_nameSite 1401:Victoria Biomedical Research Institute
        • physical_addressVictoria Biomedical Research Institute, Kisumu County Referral Hospital, P.O. Box 7180-40100, Kisumu, Kenya
        • contact_details+254720597654
        • contact_personDr Lucas Tina
        • site_capacity(null)
        • misc(null)
        • created2024-11-12 16:45:07
        • modified2024-11-13 17:15:45
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
      • 1(array)
        • id1814
        • application_id1482
        • county_id42
        • site_nameSite 1402:Ahero Clinical trials Unit
        • physical_addressAhero County Hospital.P. O Box 54- 40100 Kisumu Kenya,Along Nairobi Kisumu Highway
        • contact_details+254733966065 P.O Box 54- 40100
        • contact_personProf Bernhards Ogutu
        • site_capacity(null)
        • misc(null)
        • created2024-11-12 17:28:46
        • modified2024-11-13 17:15:45
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
      • 2(array)
        • id1815
        • application_id1482
        • county_id27
        • site_nameSite 1403:International Cancer institute
        • physical_addressInternational Cancer Institute P.O Box 8088-30100 Eldoret Kenya
        • contact_details+254700522149 P.O Box 8088-30100
        • contact_personProf Fredrick Chite
        • site_capacity(null)
        • misc(null)
        • created2024-11-12 17:28:46
        • modified2024-11-13 17:15:45
        • County(array)
          • id27
          • county_nameUasin Gishu
          • created2012-06-15 10:25:15
          • modified2012-06-15 10:25:15
      • 3(array)
        • id1816
        • application_id1482
        • county_id42
        • site_nameSite 1404:Kondele Childrens Hospital
        • physical_addressKEMRI Kondele Childrens Hospital within Jaramogi Oginga Odinga Teaching and Referral Hospital Along Kisumu Kakamenga Road. Po Box 54-40100 Kisumu kenya
        • contact_details+254733893481 PO Box 54-40100
        • contact_personDr Allan Godfrey Otieno
        • site_capacity(null)
        • misc(null)
        • created2024-11-12 17:28:46
        • modified2024-11-13 17:15:45
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
      • 4(array)
        • id1817
        • application_id1482
        • county_id42
        • site_nameSite 1405:KEMRI/CRDR KEMRI Clinical Research Annex
        • physical_addressKEMRI Clinical Research Annex -Siaya County Referral Hospital Grounds .PO Box 144-4600 Siaya Kenya
        • contact_details254724522474 PO Box 144-4600
        • contact_personProf Videlis Nduba
        • site_capacity(null)
        • misc(null)
        • created2024-11-12 17:28:46
        • modified2024-11-13 17:15:45
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
      • 5(array)
        • id1818
        • application_id1482
        • county_id47
        • site_nameSite 1406:Gertrudes Children’s Hospital
        • physical_addressGertrude’s Children’s Hospital, Muthaiga, PO Box 42325-00100 Nairobi kenya
        • contact_details+254722384218 PO Box 42325-00100
        • contact_personDr Doreen Karimi Mutua
        • site_capacity(null)
        • misc(null)
        • created2024-11-12 17:28:46
        • modified2024-11-13 17:15:45
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
    • Sponsor(array)
      • 0(array)
        • id790
        • application_id1482
        • sponsorNovartis Pharma AG
        • sponsor_typeIndustry
        • contact_personCelia Huang
        • addressSwitzerland - Basel - Werk St.Johann - WSJ-204, Basel Campus (CHBS/WSJ/204)
        • telephone_number+41 (79) 9117238
        • fax_number
        • cell_number+41 (79) 9117238
        • email_addresscelia.huang@novartis.com
        • created2024-11-12 16:45:07
        • modified2024-11-13 17:15:45
  • 1(array)
    • Application(array)
      • id1461
      • user_id21
      • trial_status_id(null)
      • abstract_of_study<p>\n A5409/RAD-TB is an adaptive Phase 2 randomized, controlled, openlabel, dose-ranging, platform protocol to evaluate the safety and efficacy of multidrug regimens for the treatment of adults with drug-susceptible pulmonary tuberculosis (TB). The adaptive design allows for regimens to be added during the trial for efficient testing of new drugs and drug combinations, identified as promising via translational modeling, against the standard of care (SOC) within the same trial infrastructure. The protocol will be amended when information becomes suitable from within or outside of the trial indicating that a new regimen is available for testing. Key aspects are the adaptive design (flexibility to add regimens as they are identified as suitable for testing), dose-finding within regimens, and the translational modeling framework. DURATION 52 weeks, inclusive of 8 weeks of experimental study treatment, followed by 18 weeks of SOC treatment. SAMPLE SIZE 45 participants in each experimental treatment arm and at least 90 participants in the SOC arm. POPULATION Participants with Xpert MTB/RIF positive drug-susceptible pulmonary TB, living with and without HIV, aged ≥18 years. STRATIFICATION Randomization will be stratified by Xpert semi-quantitative result and will additionally be balanced by site. REGIMENS Participants will be randomized to SOC (Arm 1) or to an experimental treatment arm, with twice the allocation to Arm 1 as to concurrentlyenrolling experimental treatment arms, as follows: Arm 1 (SOC): isoniazid/rifampicin/pyrazinamide/ethambutol (HRZE) for 8 weeks and then isoniazid (INH)/rifampicin (RIF) for 18 weeks, for a total of 26 weeks of anti-TB treatment, at standard doses.</p>\n<p>\n Arm 2: bedaquiline (BDQ) 400 mg for 2 weeks and then 200 mg for 6 weeks + pretomanid (Pa) 200 mg for 8 weeks + linezolid (LZD) 600 mg for 8 weeks, followed by INH/RIF for 18 weeks, for a total of 26 weeks of anti-TB treatment. Arm 3A: BDQ 400 mg for 2 weeks and then 200 mg for 6 weeks + Pa 200 mg for 8 weeks + TBI-223 1200 mg for 8 weeks, followed by INH/RIF for 18 weeks, for a total of 26 weeks of anti-TB treatment. Arm 3B: BDQ 400 mg for 2 weeks and then 200 mg for 6 weeks + Pa 200 mg for 8 weeks + TBI-223 2400 mg for 8 weeks, followed by INH/RIF for 18 weeks, for a total of 26 weeks of anti-TB treatment. Arm 4A: BDQ 400 mg for 2 weeks and then 200 mg for 6 weeks + Pa 200 mg for 8 weeks + sutezolid (SZD) 800 mg for 8 weeks, followed by INH/RIF for 18 weeks, for a total of 26 weeks of anti-TB treatment. Arm 4B: BDQ 400 mg for 2 weeks and then 200 mg for 6 weeks + Pa 200 mg for 8 weeks + SZD 1600 mg for 8 weeks, followed by INH/RIF for 18 weeks, for a total of 26 weeks of anti-TB treatment.</p>\n
      • study_title<p>\n A Phase 2, Randomized, Adaptive, Dose-Ranging, Open-Label Trial of Novel Regimens for the Treatment of Pulmonary Tuberculosis (RAD-TB)</p>\n
      • laymans_summary<p>\n A5409/RAD-TB is an adaptive Phase 2 randomized, controlled, openlabel, dose-ranging, platform protocol to evaluate the safety and efficacy of multidrug regimens for the treatment of adults with drug-susceptible pulmonary tuberculosis (TB). The adaptive design allows for regimens to be added during the trial for efficient testing of new drugs and drug combinations, identified as promising via translational modeling, against the standard of care (SOC) within the same trial infrastructure.</p>\n
      • short_titleA5409
      • protocol_noECCT/24/10/06
      • version_noVersion 2.0
      • date_of_protocol21-03-2024
      • study_drugbedaquiline, pretomanid,sutezolid.
      • disease_conditionPulmonary Tuberculosis.
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device0
      • product_type_chemical_nameRifampicin Isoniazid Pyrazinamide Ethambutol Hydrochloride
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressviola.kirui@gmail.com
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries(null)
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan1
      • applicant_contractual_agreement1
      • declaration_applicantDr. Charity Wambui Kanyoro
      • declaration_date125-10-2024
      • declaration_principal_investigatorDr. Charity Wambui Kanyoro
      • declaration_date225-10-2024
      • placebo_presentNo
      • study_objectives<p>\n <strong>Primary Objectives</strong></p>\n<p>\n 1 To compare MGIT liquid culture TTP slope over the first 6 weeks of treatment for each experimental treatment arm to the SOC arm.</p>\n<p>\n 2 To compare new Grade 3 or higher adverse events (AEs) (safety) over the first 8 weeks of treatment for each experimental treatment arm to the SOC arm. 1.3 <strong>Secondary Objectives</strong></p>\n<p>\n 1.To compare time to stable culture conversion by MGIT liquid culture by week 8 for each experimental treatment arm to the SOC arm.</p>\n<p>\n 2 To compare MGIT liquid culture TTP slope over the first 8 weeks of treatment for each experimental treatment arm to the SOC arm.</p>\n<p>\n 3. To compare new Grade 3 or higher AEs (safety) over 26 weeks of treatment for each experimental treatment arm to the SOC arm.</p>\n<p>\n 4.To compare discontinuations of anti-TB drugs for any reason prior to 8 and 26 weeks of treatment for each experimental treatment arm to the SOC arm.</p>\n<p>\n 5. To determine the dose- and exposure-response relationships between experimental drug estimated pharmacokinetic (PK) parameters with safety and efficacy.</p>\n<p>\n 6. To compare a composite of efficacy and safety outcomes using a risk-benefit approach for each experimental treatment arm to the SOC arm.</p>\n<p>\n 7. To compare MGIT liquid culture TTP slope over the first 6 weeks of treatment for Arms 3A-3B and Arms 4A-4B compared to Arm 2.</p>\n<p>\n 8 To compare durable cure by 52 weeks after treatment initiation in each experimental treatment arm to the SOC arm. </p>\n<p>\n <strong>Exploratory Objectives</strong></p>\n<p>\n 1 To project a hazard ratio comparing time to stable culture conversion for each experimental treatment arm to the SOC arm.</p>\n<p>\n 2 To compare TTP with time to culture conversion outcome measurements. </p>\n<p>\n 3 To compare sputum ribosomal synthesis ratio (RS ratio) quantification over the first 8 weeks of treatment and at 26 weeks of treatment for each experimental treatment arm to the SOC arm.</p>\n<p>\n 4 To describe the proportion of participants with culture conversion by MGIT liquid culture during the first 8 weeks of treatment in each experimental treatment arm and the SOC arm.</p>\n<p>\n 5 To obtain qualitative data on the acceptability of the assigned treatment regimens among people living with TB. 1.4.6 To evaluate whether Mtb-specific T-cell phenotype and function, and transcriptomic signatures, can be used to monitor treatment response.</p>\n
      • principal_inclusion_criteria<p>\n 1.Pulmonary TB (among individuals either without history of prior TB treatment or with history of TB treatment more than 5 years prior to study entry), identified within 7 days prior to study entry by at least one sputum specimen positive for Mtb by Xpert. Semiquantitative Mtb results of “medium” or “high” are required [Hanrahan 2014].</p>\n<p>\n 2.Pulmonary TB with documented INH susceptibility (by Line Probe Assay (LPA) or Xpert MTB/XDR or other validated molecular test) and with documented RIF susceptibility (by LPA or Xpert MTB/RIF or Xpert MTB/RIF Ultra or other validated molecular test) within 7 days prior to study entry. NOTE: In cases shown to be RIF and INH susceptible by molecular test, but later confirmed to be resistant to either according to phenotypic DST, the participants will be taken off study-provided drugs, referred to the national TB program (NTP) or local TB clinic/provider for treatment of their TB according to local SOC, and excluded from the efficacy analyses. The documentation of INH and RIF susceptibility must be from a study testing laboratory</p>\n<p>\n 3.Documentation of HIV-1 infection status, as below: 38 A5409 FINAL Version 2.0 21Mar2024 Presence or Absence of HIV-1 infection, as documented by: • Any licensed rapid HIV test or HIV-1 enzyme or chemiluminescence immunoassay (E/CIA) test kit, any time prior to study entry. AND Confirmed by one of the following: • A second antibody test from different manufacturers or based on different principles and epitopes (combination antigen-antibody-based rapid tests may be used), or • HIV-1 antigen, or • Plasma HIV-1 RNA viral load, or • A licensed Western blot NOTE A: The term “licensed” refers to a U.S. FDA-approved kit. NOTE B: WHO and U.S. Centers for Disease Control and Prevention (CDC) guidelines mandate that confirmation of the initial test result must use a test that is different from the one used for the initial assessment. A reactive initial rapid test should be confirmed by either another type of rapid assay or an E/CIA that is based on a different antigen preparation and/or different test principle (e.g., indirect versus competitive), or a Western blot or a plasma HIV-1 RNA viral load.</p>\n<p>\n 4.For individuals with HIV: CD4+ cell count ≥100 cells/mm3 based on testing performed within 30 days prior to study entry. NOTE: CD4+ cell count must be obtained from a laboratory certified for protocol testing by the DAIDS Immunology Quality Assurance (IQA) Program.</p>\n<p>\n 5.For individuals with HIV: Currently being treated with dolutegravir-based antiretroviral therapy (ART), or plan to initiate dolutegravir-based ART at or before study week 8. NOTE: See section 5.4.2 and Appendices I-V for a list of excluded ARV medications. Dosing of ART should be reflective of local SOC based on WHO or national guidelines, and adjusted, as needed, when given in combination with RIF-containing TB therapy.</p>\n<p>\n 6.Individuals age ≥18 years.</p>\n<p>\n 7.The following laboratory values obtained within 7 days prior to study entry at any network-approved non-US laboratory that operates in accordance with Good Clinical Laboratory Practices (GCLP) and participates in appropriate external quality assurance programs: 39 A5409 FINAL Version 2.0 21Mar2024 • Serum or plasma alanine aminotransferase (ALT) ≤3 times the upper limit of normal (ULN) • Serum or plasma total bilirubin ≤2 times ULN • Serum or plasma creatinine ≤2 times ULN • Serum or plasma potassium ≥3.5 mEq/L • Serum or plasma magnesium ≥1.0 mEq/L (≥0.500 mmol/L) • Absolute neutrophil count (ANC) ≥1500/mm3 • Hemoglobin ≥9.5 g/dL for individuals assigned to female sex at birth and ≥10.0 g/dL for individuals assigned to male sex at birth • Platelet count ≥100,000/mm3 • Negative for hepatitis B core antibody (HBcAb) total, hepatitis B surface antigen (HBsAg) • Negative for hepatitis C virus (HCV) antibody (or if HCV antibody positive, must have a negative HCV PCR) NOTE: For hypokalemia or hypomagnesemia, potassium and magnesium may be repleted and electrolytes rechecked once before study entry.</p>\n<p>\n 8.For individuals assigned female sex at birth and who are of reproductive potential, negative pregnancy test (urine HCG or serum β-HCG) within 3 days (72 hours) prior to entry by any network-approved non-US laboratory or clinic that operates in accordance with GCLP and participates in appropriate external quality assurance programs. Individuals assigned female sex at birth, who are of reproductive potential, and who participate in sexual activity that could lead to pregnancy must agree to use at least two of the following forms of birth control while receiving TB study medications and for 12 months after stopping study medications: • Male or female condoms • Diaphragm or cervical cap (with spermicide, if available) • Intrauterine device (IUD) or intrauterine system (IUS) • Hormone-based birth control (e.g., oral contraceptives, Depo-Provera, NuvaRing, implants) NOTE: Individuals assigned female sex at birth who are not of reproductive potential are eligible without requiring the use of contraceptives. Self-reported history is acceptable documentation of menopause (i.e., at least 1 year amenorrheic), hysterectomy, bilateral oophorectomy, or bilateral tubal ligation; these candidates are all considered not of reproductive potential.</p>\n<p>\n 9.For individuals who are assigned male sex at birth who engage in sexual activity that may lead to pregnancy in their partner must agree to either remain abstinent or use male contraceptives. They are also strongly advised to inform their non- 40 A5409 FINAL Version 2.0 21Mar2024 pregnant sexual partners of reproductive potential to use effective contraceptives while the individual is on study and for 90 days after experimental treatment discontinuation. NOTE: Individuals assigned male sex at birth who have undergone successful vasectomy with documented azoospermia or have documented azoospermia for any other reason, are eligible without requiring the use of contraceptives.</p>\n<p>\n 10.For individuals assigned male sex at birth with pregnant partners, willingness to use condoms during vaginal intercourse while on study and for 90 days after experimental treatment discontinuation.</p>\n<p>\n 11.For individuals assigned male sex at birth, willingness to refrain from sperm donation while on study and for 90 days after experimental treatment discontinuation.</p>\n<p>\n 12.Documentation of Karnofsky performance score ≥60 obtained within 14 days prior to study entry.</p>\n<p>\n 13.Chest x-ray obtained within 14 days prior to study entry.</p>\n<p>\n 14.A verifiable address or residence readily accessible for visiting, and willingness to inform the study team of any change of address during study treatment and follow-up period.</p>\n<p>\n 15.Ability and willingness of individual to provide informed consent.</p>\n
      • principal_exclusion_criteria<p>\n 1.More than cumulative 7 days of treatment directed against active TB for the current TB episode in the 60 days preceding study entry.</p>\n<p>\n 2.Current extrapulmonary TB, in the opinion of the investigator</p>\n<p>\n 3.QTcF interval >450 ms within 7 days prior to study entry. NOTE: In case of hypokalemia or hypomagnesemia, ECG can be repeated once before study entry following electrolyte supplementation.</p>\n<p>\n 4.History of, or ongoing, heart failure.</p>\n<p>\n 5.Personal or family history of congenital QT prolongation.</p>\n<p>\n 6.History of known, untreated, ongoing hypothyroidism</p>\n<p>\n 7.History of ongoing bradyarrhythmia.</p>\n<p>\n 8.History of torsades de pointes</p>\n<p>\n 9.Current Grade 2 or higher peripheral neuropathy. NOTE: Peripheral neuropathy assessment must be obtained within 7 days prior to study entry.</p>\n<p>\n 10.Other medical conditions (e.g., diabetes, liver or kidney disease, blood disorders, chronic diarrhea), in the opinion of the site investigator, in which the current clinical condition of the participant is likely to prejudice the response to, or assessment of, treatment.</p>\n<p>\n 11.Pregnant or breastfeeding or planning to become pregnant within the next 12 months.</p>\n<p>\n 12.Weight <35 kg.</p>\n<p>\n 13.Unable to take oral medications.</p>\n<p>\n 14.Taking any of the prohibited medications as described in section 5.4.2 and the appendices for the investigational agents.</p>\n<p>\n 15.Known allergy/sensitivity or any hypersensitivity to components of investigational agents or their formulation.</p>\n<p>\n 16.Active drug or alcohol use or dependence; or mental illness (e.g., major depression) that, in the opinion of the site investigator, would interfere with adherence to study requirements.</p>\n<p>\n 17.Taking an investigational drug or vaccine within 30 days prior to study entry.</p>\n
      • primary_end_points<div>\n To compare MGIT liquid culture TTP slope over the first 6 weeks of treatment for each experimental treatment arm to the SOC arm.</div>\n<div>\n To compare new Grade 3 or higher adverse events (AEs) (safety) over the first 8 weeks of treatment for each experimental treatment arm to the SOC arm.</div>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response1
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory1
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<ol font-size:=\"\" style=\"padding-right: 0px; padding-left: 0px; margin: 0px 0px 10px 25px; color: rgb(51, 51, 51);\" trebuchet=\"\">\n <li style=\"line-height: 20px;\">\n Dr. Charity Wambui Kanyoro                                      Principal Investigator</li>\n <li style=\"line-height: 20px;\">\n Dr. Hildah Chavera Kazigah                                         Co- Investigator</li>\n <li style=\"line-height: 20px;\">\n Getrude Jerop Kiptoo                                              Study Clinician          </li>\n <li style=\"line-height: 20px;\">\n Grace Jepkemei Cheruiyot                                      Medical Officer                      </li>\n <li style=\"line-height: 20px;\">\n Philemon Kipchirchir Mutai                                     Study Nurse</li>\n <li style=\"line-height: 20px;\">\n Victor Kibet Langat                                                  Study Nurse</li>\n <li style=\"line-height: 20px;\">\n Damaris Lagat                                           Quality Assurance/Control officer</li>\n <li style=\"line-height: 20px;\">\n Shauri Gona                                              Recruitment officer</li>\n <li style=\"line-height: 20px;\">\n Julie Choge                                                     Recruitment officer</li>\n <li style=\"line-height: 20px;\">\n Florence Njulu                                            regulatory Officer</li>\n <li style=\"line-height: 20px;\">\n Wilson Ekiru                                                  Assistant data manager</li>\n <li style=\"line-height: 20px;\">\n Martha Mokaya                                             Data manger           </li>\n <li style=\"line-height: 20px;\">\n Natalie Sang                                         Pharmacist of record</li>\n <li style=\"line-height: 20px;\">\n Beatrice Jakait                                               Backup pharmacist</li>\n <li style=\"line-height: 20px;\">\n Salina Cherutich                                            Pharmaceutical technologist</li>\n <li style=\"line-height: 20px;\">\n Vincent Onyango                                           Phlebotomist</li>\n <li style=\"line-height: 20px;\">\n Scholastica Njeri Wanjiru                               Pharmacist.</li>\n <li style=\"line-height: 20px;\">\n <span background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"font-size: 12pt; font-family: \" times=\"\">Mowlem Pierre                                  Laboratory technologist</span></li>\n <li style=\"line-height: 20px;\">\n Kennedy Oyamo                                            Laboratory technologist</li>\n <li style=\"line-height: 20px;\">\n Agnes Mwende Nzioka                                  Study Clinician </li>\n <li style=\"line-height: 20px;\">\n  </li>\n</ol>\n<p style=\"margin: 0px 0px 10px;\">\n  </p>\n
      • other_details_explanation<p>\n <span font-size:=\"\" style=\"color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">The outcome of this trial will have major public health implications for areas of the world with high burdens of Pulmonary tuberculosis. The sponsor Country (US) does not fall in this category.</span></p>\n
      • other_details_regulatory_notapproved<p>\n None</p>\n
      • other_details_regulatory_approved<p>\n <span font-size:=\"\" style=\"color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">Moi Teaching and Referral Hospital/Moi University Institutional Research and Ethics Committee (IREC). Approval granted on 16 August 2024  for the Eldoret site.</span></p>\n
      • other_details_regulatory_rejected<p>\n None</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration52 weeks
      • design_controlled_randomisedYes
      • design_controlled_openYes
      • design_controlled_single_blindNo
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupYes
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorStandard of Care
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesYes
      • multiple_member_states3
      • number_of_sites2
      • multi_country_listMALAWI,SOUTH AFRICA,THAILAND
      • data_monitoring_committeeYes
      • total_enrolment_per_siteKEMRI/WRP 60\nMOI UNIVERSITY 60\n
      • total_participants_worldwide315
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyYes
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameCharity
      • investigator1_middle_nameWambui
      • investigator1_family_nameKanyoro
      • investigator1_qualificationMBChB, MMed
      • investigator1_professional_addressP O BOX 4606-30100
      • investigator1_telephone+254721270365
      • investigator1_emailckwambui@gmail.com
      • organisations_transferred_No
      • number_participants60
      • notification
      • approval_date18-11-2025
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted25-10-2024
      • is_child0
      • unsubmitted1
      • initial_date_submitted25-10-2024
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonThe reviewer comments has been addressed.
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2025-11-18 14:35:37
      • created2024-08-29 13:34:56
      • total_sites1
      • ecitizen_invoice319863
    • InvestigatorContact(array)
      • 0(array)
        • id1141
        • application_id1461
        • given_nameCharity
        • middle_nameWambui
        • family_nameKanyoro
        • qualificationMBChB, MMed
        • professional_addressP O BOX 4606-30100
        • telephone+254721270365
        • emailckwambui@gmail.com
        • created2024-08-29 13:37:11
        • modified2025-02-21 11:51:03
    • SiteDetail(array)
      • 0(array)
        • id1775
        • application_id1461
        • county_id35
        • site_nameKEMRI/WRP CRS
        • physical_addressKERICHO COUNTY HOSPITAL GROUNDS
        • contact_details0722941525
        • contact_personMARY LELGO
        • site_capacity(null)
        • misc(null)
        • created2024-08-29 13:37:11
        • modified2025-02-21 11:51:03
        • County(array)
          • id35
          • county_nameKericho
          • created2012-06-15 10:26:16
          • modified2012-06-15 10:26:16
    • Sponsor(array)
      • 0(array)
        • id775
        • application_id1461
        • sponsorNational Institute of Allergy and Infectious Diseases
        • sponsor_typeOthers
        • contact_personRadojka Savic, PharmD, PhD
        • addressUniversity of California, San Francisco 1700 4th Street
        • telephone_number415-502-0640
        • fax_number
        • cell_number415-502-0640
        • email_addressrada.savic@ucsf.edu
        • created2024-08-29 13:37:11
        • modified2025-02-21 11:51:03
  • 2(array)
    • Application(array)
      • id1445
      • user_id263
      • trial_status_id1
      • abstract_of_study<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n This rollover study will be conducted primarily to enable continued access to CAB LA + RPV LA and also to</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n collect long-term safety and tolerability data as specified in the Schedule of Activities in</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n participants who completed the parent studies and who at the time of rollover, experience and are</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n expected to continue to experience clinical benefit from the regimen, and have no other access to</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n locally available CAB LA + RPV LA.</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n At the time of rollover, the investigator should assess whether the participant still benefit</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n clinically from CAB LA + RPV LA treatment according to the antiviral activity and safety criteria</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n as set out in the protocol of the parent study that the participant was participating in prior to this</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n rollover study. The investigator should also be confident that the participant is expected to continue</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n to experience clinical benefit from CAB LA + RPV LA treatment.</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n Participation in the rollover study is voluntary, and the decision to participate must be made jointly</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n by the investigator and the participant or legally acceptable representative. Participants who do not</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n opt to transition to the rollover study at the end of the CAREs study will be switched to SOC ART</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n per local regulations and availability.</p>\n
      • study_title<p>\n A Phase 4, Open-Label, Rollover Study to Provide Continued Access to Cabotegravir Long-acting Injection and Rilpivirine Long-acting Injection to Participants Living with Human Immunodeficiency Virus Type 1 (HIV-1) Infection Who Participated in Long-acting Combination Therapy Studies</p>\n
      • laymans_summary<p>\n <span style=\"color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">Cabotegravir (CAB) is a potent integrase strand transfer inhibitor (INSTI) with attributes allowing formulation and delivery as a long-acting (LA) parenteral product. Rilpivirine (RPV), also formulated as a LA product, is a diarylpyrimidine derivative and a potent non-nucleoside reverse transcriptase inhibitor (NNRTI) with in vitro activity against wild type HIV-1 and select NNRTI-resistant mutants. The combination of CAB LA and RPV LA has been shown in clinical trials in virologically suppressed adults living with HIV to be safe, well-tolerated and efficacious as a complete injectable antiretroviral regimen. This study enables continued CAB LA + RPV LA access to participants who were included in the clinical development studies for CAB LA + RPV LA (IMPAACT 2017 [MOCHA], IMPAACT 2036 [CRAYON], IMPAACT 2040 [CREATE], TMC278LAHTX3002 [CARES], TMC278LAHTX3005 [IMPALA], in the following sections referred to as the parent studies) and who continue to benefit clinically from the regimen but do not have access to locally available CAB LA + RPV LA to continue treatment. The rollover study will be reviewed periodically to evaluate other access options. </span></p>\n
      • short_titleCabotegravir + Rilpivirine Inj
      • protocol_noECCT/24/10/05
      • version_noOriginal
      • date_of_protocol12-01-2024
      • study_drugCabotegravir + Rilpivirine Inj
      • disease_conditionHIV/Aids
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device0
      • product_type_chemical_nameTMC278
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressamina.salim@iqvia.com
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries(null)
      • applicant_addendum0
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter0
      • applicant_detailed_budget1
      • applicant_indemnity_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan1
      • applicant_contractual_agreement1
      • declaration_applicantJoyce Chelulei
      • declaration_date124-10-2024
      • declaration_principal_investigatorProf Abraham Siika
      • declaration_date224-10-2024
      • placebo_presentNo
      • study_objectives<div>\n  </div>\n<div>\n <table class=\"table table-condensed\" font-size:=\"\" style=\"max-width: 100%; border-collapse: collapse; border-spacing: 0px; width: 917.271px; margin-bottom: 20px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <tbody>\n <tr>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top-style: solid; border-top-color: rgb(221, 221, 221);\">\n <p style=\"margin: 0px 0px 10px;\">\n Primary Objective</p>\n <p style=\"margin: 0px 0px 10px;\">\n The primary objective of the study is to provide continued CAB LA + RPV LA access to participants who were enrolled and treated with CAB LA + RPV LA in the parent studies, and who, at the time of rollover, experience and are expected to continue to experience clinical benefit from this treatment.</p>\n <p style=\"margin: 0px 0px 10px;\">\n  </p>\n <p style=\"margin: 0px 0px 10px;\">\n Secondary Objective</p>\n <p style=\"margin: 0px 0px 10px;\">\n The secondary objective is to assess the long-term safety and tolerability of CAB LA + RPV LA by evaluating the incidence of serious adverse events (SAEs), pregnancies, adverse events (AEs) leading to discontinuation of CAB LA + RPV LA and AEs considered to be related to the study intervention.</p>\n </td>\n </tr>\n </tbody>\n </table>\n</div>\n<p>\n  </p>\n
      • principal_inclusion_criteria<p>\n Each potential participant must satisfy all the following criteria to be enrolled in the study:</p>\n<p>\n 1. Participants (or their legally acceptable representative) must sign an ICF indicating that they understand the purpose of, and procedures required for the study and are willing to participate in the study. Assent is also required of children capable of understanding the nature of the study (in keeping with local regulations).</p>\n<p>\n 2. Participants living with HIV-1 infection who were treated with CAB LA + RPV LA in any of the following parent studies: TMC278LAHTX3002 (CARES), TMC278LAHTX3005 (IMPALA), IMPAACT 2017 (MOCHA), IMPAACT 2036 (CRAYON), IMPAACT 2040 (CREATE), and completed the protocol-defined treatment period.</p>\n<p>\n 3. Has benefited clinically from treatment with CAB LA + RPV LA in the opinion of the investigator and will continue to benefit clinically from this intervention.</p>\n<p>\n 4. Must be able and willing to comply with the rollover protocol requirements.</p>\n<p>\n 5. Participant’s general medical condition, in the opinion of the investigator, does not interfere with participation in this study. </p>\n
      • principal_exclusion_criteria<p>\n Any potential participant who meets any of the following criteria will be excluded from participating in the study:</p>\n<p>\n 1. Participants using disallowed concomitant treatment.</p>\n<p>\n 2. Participants who were withdrawn from the previous parent study with CAB LA + RPV LA that they were participating in prior to this rollover study, based on any of the mandatory withdrawal criteria. </p>\n
      • primary_end_points<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n The end of study is considered as the last visit for the last participant in the study. The final data from the study site will be sent to the sponsor (or designee) after completion of the final participant visit at that study site, in the time frame specified in the Clinical Trial Agreement.</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Participants who prematurely discontinue study intervention for any reason before study completion can be considered to have completed the study if they have completed all the scheduled assessments at that time-point.</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy1
      • scope_safety0
      • scope_efficacy0
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use1
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\">\n <tbody>\n <tr>\n <td style=\"width:213px;\">\n <p>\n <strong>ROLE</strong></p>\n </td>\n <td style=\"width:424px;\">\n <p>\n <strong>STAFF</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:213px;\">\n <p>\n Principal Investigator</p>\n </td>\n <td style=\"width:424px;\">\n <p style=\"margin-left:.5pt;\">\n Abraham Mosigisi Siika, MBChB, MMed, MS</p>\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:213px;\">\n <p>\n Sub-Investigator</p>\n </td>\n <td style=\"width:424px;\">\n <p style=\"margin-left:.5pt;\">\n Charity Wambui, MBChB, MMed</p>\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:213px;\">\n <p>\n Site Coordinator</p>\n </td>\n <td style=\"width:424px;\">\n <p style=\"margin-left:.5pt;\">\n Viola Cherotich Kirui, BSc,</p>\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:213px;\">\n <p style=\"margin-left:.5pt;\">\n Regulatory Affairs Officers</p>\n <p style=\"margin-left:.5pt;\">\n  </p>\n </td>\n <td style=\"width:424px;\">\n <p style=\"margin-left:.5pt;\">\n Florence Kiwunja Njulu BSc (EVH)</p>\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:213px;\">\n <p>\n  </p>\n </td>\n <td style=\"width:424px;\">\n <p>\n Cornelius Chege, BSc</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:213px;\">\n <p style=\"margin-left:.5pt;\">\n Study Pharmacist</p>\n <p>\n  </p>\n </td>\n <td style=\"width:424px;\">\n <p style=\"margin-left:.5pt;\">\n Natalie Sang, BPharm, MPharm (Clinical)</p>\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td rowspan=\"4\" style=\"width:213px;\">\n <p style=\"margin-left:.5pt;\">\n Study Pharmacy Technologists</p>\n <p style=\"margin-left:.5pt;\">\n  </p>\n </td>\n <td style=\"width:424px;\">\n <p style=\"margin-left:.5pt;\">\n Salina Cherutich, Pharm Tech</p>\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:424px;\">\n <p>\n Benedister Kangogo Cheruiyot, Pharm tech</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:424px;\">\n <p>\n Brian Moses Odul, Pharm Tech</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:424px;\">\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:213px;\">\n <p style=\"margin-left:.5pt;\">\n Study Medical Officer</p>\n <p style=\"margin-left:.5pt;\">\n  </p>\n </td>\n <td style=\"width:424px;\">\n <p style=\"margin-left:.5pt;\">\n Hilda Chavera Kaziga, MBChB,</p>\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td rowspan=\"5\" style=\"width:213px;\">\n <p>\n Study Clinical Officer(s)</p>\n </td>\n <td style=\"width:424px;\">\n <p style=\"margin-left:.5pt;\">\n Jairus Kipyego, MPH, BSc, Dip Clinical Medicine & Surgery</p>\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:424px;\">\n <p style=\"margin-left:.5pt;\">\n Viola Samoei, Dip Clinical Medicine & Surgery</p>\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:424px;\">\n <p style=\"margin-left:.5pt;\">\n Tom Oyoo Osoro, Dip Clinical Medicine & Surgery</p>\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:424px;\">\n <p>\n Clinton Otieno Achida, Dip Clinical Medicine & Surgery</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:424px;\">\n <p>\n Getruth Jerop Kiptoo, Dip Clinical Medicine & Surgery</p>\n </td>\n </tr>\n <tr>\n <td rowspan=\"3\" style=\"width:213px;\">\n <p style=\"margin-left:.5pt;\">\n Data Manager(s)</p>\n <p>\n  </p>\n </td>\n <td style=\"width:424px;\">\n <p>\n Martha Bisieri Mokaya, BSc, MSc</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:424px;\">\n <p>\n Wilson Lokitala Ekiru, BSc,</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:424px;\">\n <p>\n Ruth Bosire</p>\n </td>\n </tr>\n <tr>\n <td rowspan=\"3\" style=\"width:213px;\">\n <p style=\"margin-left:.5pt;\">\n Data Officer (s)</p>\n <p>\n  </p>\n </td>\n <td style=\"width:424px;\">\n <p>\n Matthew Justus Mutuku</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:424px;\">\n <p>\n Festus Kirwa Rugut</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:424px;\">\n <p>\n Risper Chepkoech Biwott</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:213px;\">\n <p style=\"margin-left:.5pt;\">\n Laboratory Director</p>\n <p>\n  </p>\n </td>\n <td style=\"width:424px;\">\n <p style=\"margin-left:.5pt;\">\n Ronald Kibet Tonui, MBChB, MSc.</p>\n </td>\n </tr>\n <tr>\n <td rowspan=\"3\" style=\"width:213px;\">\n <p>\n Study Nurse</p>\n </td>\n <td style=\"width:424px;\">\n <p>\n Joan Kotut</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:424px;\">\n <p>\n Eunice Jepkemboi</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:424px;\">\n <p style=\"margin-left:.5pt;\">\n Philemon Kipchirchir Mutai</p>\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td rowspan=\"6\" style=\"width:213px;\">\n <p style=\"margin-left:.5pt;\">\n Recruitment Officer(s)</p>\n <p>\n  </p>\n </td>\n <td style=\"width:424px;\">\n <p>\n Cecilia Chebet Mengich</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:424px;\">\n <p>\n Julie Chepchumba Choge</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:424px;\">\n <p>\n Dorcas Akinyi Opot</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:424px;\">\n <p>\n Solomon Kimurgor Ngetich</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:424px;height:29px;\">\n <p>\n Evans Ochieng Ouno</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:424px;\">\n <p>\n Shauri Gona</p>\n </td>\n </tr>\n </tbody>\n</table>\n<p style=\"margin-left:.5pt;\">\n  </p>\n<p style=\"margin-left:.5pt;\">\n <strong>SITE DESCRIPTION</strong></p>\n<p style=\"margin-left:.5pt;\">\n <strong>Historical background</strong></p>\n<p style=\"margin-left:.5pt;\">\n In 2004, the Moi University Clinical Research Centre (MUCRC) was founded as an</p>\n<p style=\"margin-left:.5pt;\">\n international site of the Indiana University AIDS Clinical Trials Unit (ACTU), an affiliate</p>\n<p style=\"margin-left:.5pt;\">\n of the AIDS Clinical Trials Group (ACTG) Network. Following two years of site</p>\n<p style=\"margin-left:.5pt;\">\n preparation, trial A5208/OCTANE (Optimal Combination Therapy After Nevirapine Exposure) was initiated at the MUCRC in July 2006. In December 2006, Indiana University was defunded from the ACTG Network and the MUCRC reverted to the Division of AIDS (DAIDS) of the National Institutes of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), as a protocol-limited site. In December 2008, MUCRC became a site for the United States Military HIV Research Program (USMHRP) and continues to perform clinical trials for the ACTG Network.</p>\n<p style=\"margin-left:.5pt;\">\n While MUCRC is a clinical trials site for the USMHRP, it operates under the auspices of the</p>\n<p style=\"margin-left:.5pt;\">\n USAID – Academic Model Providing Access to Healthcare Research Network (AMPATH</p>\n<p style=\"margin-left:.5pt;\">\n ResNet). AMPATH, founded in November 2001, is a collaboration between the Moi University School of Medicine (MUSoM), Moi Teaching and Referral Hospital (MTRH) and a network of North American Medical Schools (the AMPATH Consortium) led by Indiana University School of Medicine (IUSoM).</p>\n<p style=\"margin-left:.5pt;\">\n  </p>\n<p style=\"margin-left:.5pt;\">\n <strong>MUCRC Location and Staffing</strong></p>\n<p style=\"margin-left:.5pt;\">\n The MUCRC is located on the second floor of the Chandaria Cancer and Chronic Diseases Centre, Eldoret, Kenya. The CRS has the following areas/rooms: a waiting bay for patients; a nursing station(for consenting, vital signs measurements); a phlebotomy room; three clinical examination rooms; a pharmacy (including a separate cyctoxics preparation room) one data room; four offices (one each for the site coordinator and regulatory affairs coordinator and quality assurance/control officer, the pharmacist, recruiters and one investigators room); a staff recreational room; and separate toilets for staff and patients.</p>\n<p style=\"margin-left:.5pt;\">\n MUCRC has a total of 9 Investigators, one Pharmacist, one backup associate pharmacist, one backup Pharmacy technologist; one Site Coordinator; and QA/QC officer; three Clinical Officers, three data personnel, one Laboratory Manager, one study nurse and three Recruiters.</p>\n<p style=\"margin-left:.5pt;\">\n  </p>\n<p style=\"margin-left:.5pt;\">\n <strong>Population and Socioeconomic Environment</strong></p>\n<p style=\"margin-left:.5pt;\">\n The AMPATH catchment area includes 35 main clinic sites in western Kenya and more than 530 sub-locations. AMPATH research projects are active at clinic sites throughout the catchment area as well as in the communities served by AMPATH clinics. The western Kenya region has a population 16 million (40% of Kenya’s population, national HIV prevalence of 7.2%). The main economic activities in the region are agriculture (mainly subsistence farming and fishing) and cross border trade. A few tourist spots are spread throughout the region. Recently, Eldoret and Kisumu (2nd largest city in Kenya situated on the shores of Lake Victoria) have become popular spots for the establishment of middle and higher level training institutions as well as medical and nonmedical research centers.</p>\n<p style=\"margin-left:.5pt;\">\n AMPATH has enrolled over 200,000 HIV-infected patients in all its clinics. Approximately half of these patients have initiated Antiretroviral Therapy (ART). With >30,000 enrolled patients, AMPATH Center at the Moi Teaching and Referral Hospital (MTRH) in Eldoret, is the largest and busiest of all AMPATH clinics. The clinical care service at AMPATH Center is organized into 4 modules (3 adult and 1 pediatric). All adult modules are similar in staff composition. Clinicians in each Module care for their own set of patients with minimal crossover of patients between the Modules. All HIV care offered is protocolized.</p>\n<p style=\"margin-left:.5pt;\">\n A central registration system assigns patients <13 years of age to the pediatric module (M4) while adult patients are randomly assigned to the 3 adult modules (M1 – M3).</p>\n<p style=\"margin-left:.5pt;\">\n HIV-TB care is provided in all the AMPATH clinics. At the AMPATH centre in Eldoret, the</p>\n<p style=\"margin-left:.5pt;\">\n diagnostic work up for TB patients is done at modules I-III after which patients are referred to room 15 for subsequent care and follow up. Patients with smear positive TB are followed up at the TB clinic, a minute’s walk from the AMPATH clinic. The National TB and Leprosy Programme is notified of all TB cases</p>\n<p style=\"margin-left:.5pt;\">\n  </p>\n<p style=\"margin-left:.5pt;\">\n <strong>Laboratory Capacity</strong></p>\n<p style=\"margin-left:.5pt;\">\n Five main laboratories are available on site:</p>\n<p style=\"margin-left:.5pt;\">\n <strong>1. AMPATH Reference Laboratory</strong>: Immunology (single platform flow cytometry) for CD3, CD4, CD8 and Lymphocyte Counts (absolute and %); Molecular Biology for HIV DNA, Viral Loads for HIV (real time and end point PCR), GC PCR, Chlamydia PCR, TB PCR, HIV Genotyping (currently under discussion with Abbott);Serology for Hepatitis B surface antigen (rapid test), HIV ELISA, Herpes Simplex Virus ELISA, Pregnancy testing (urinary hCG), Syphilis testing by RPR (Rapid Plasma Reagin) and Treponema pallidum haemagglutination assay, toxoplasma antibody, cryptococcal antigen, streptococcal antigen, histoplasma antigen, and anti-histoplasma antibody. The site recently received VQA certification for pVL testing.</p>\n<p style=\"margin-left:.5pt;\">\n <strong>2. AMPATH Modular Laboratory:</strong> Biochemistry (automated, colorimetric and ion sensitive electrode) for Albumin, Alanine Aminotransferase, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bicarbonate, Bilirubin, Chloride, Cholesterol, Creatine Kinase, Creatinine, Glucose, High Density and Low Density Lipoproteins –HDL/LDL cholesterol, Lactic Acid, Lipase, Potassium, Sodium, Total Protein, Triglycerides, Blood Urea Nitrogen; Hematology (automated, impedance/laser, 22 parameters) for White Blood Cells (total and differential counts for neutrophils, lymphocytes, monocytes, eosinophils and basophils), Red Blood Cell Count,</p>\n<p style=\"margin-left:.5pt;\">\n Hemoglobin, Hematocrit, Mean Cell Volume, Mean Cell Hemoglobin and Mean Cell Hemoglobin Concentration, Red Cell Distribution Width, Platelet Count, Mean Platelet</p>\n<p style=\"margin-left:.5pt;\">\n Volume, Platelet Concentration, and Platelet Distribution Width.</p>\n<p style=\"margin-left:.5pt;\">\n <strong>3. AMPATH/WHO Tuberculosis Laboratory:</strong> Microscopy for Acid Fast Bacilli from direct</p>\n<p style=\"margin-left:.5pt;\">\n smears and concentrates; Culture for Acid Fast Bacilli (Lowenstein Jensen and MGIT),</p>\n<p style=\"margin-left:.5pt;\">\n Identification of Mycobacterium tuberculosis complex (by rapid test); Drug</p>\n<p style=\"margin-left:.5pt;\">\n Susceptibility Testing (DST), Gene Expert diagnostic Kit for TB</p>\n<p style=\"margin-left:.5pt;\">\n <strong>4. MTRH Microbiology Laboratory:</strong> Microscopy for Gram, Giemsa, Leishmanin, modified</p>\n<p style=\"margin-left:.5pt;\">\n acid fast for Nocardia and Cryptosporidium, methenamine silver nitrate, Indian ink, KOH, wet preparations, cell counts; Cultures for bacterial and fungal on biological fluids.</p>\n<p style=\"margin-left:.5pt;\">\n <strong>5. MUSoM Histopathology Laboratory:</strong> Histology for Hematoxylin/Eosin, Giemsa, and</p>\n<p style=\"margin-left:.5pt;\">\n modified Ziehl Neelsen stains; immunohistochemistry and flow cytometry. Backup Laboratories</p>\n<p style=\"margin-left:.5pt;\">\n The MUCRC will utilize the following backup laboratories for tests that cannot be conducted at the site or for which protocol approval has not been granted by the sponsor.</p>\n<ol>\n <li>\n Kenya Medical Research Institute/ Walter Reed Project Clinical Research Center, Laboratory, Kericho.</li>\n <li>\n Kenya Medical Research Institute/Center for Disease Control (KEMRI/CDC) TB Research Laboratory, Kisumu.</li>\n</ol>\n
      • other_details_explanation<p>\n <span font-size:=\"\" style=\"color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">This is a Phase 4, non-randomized, open-label, multicenter, multicountry, rollover study in participants living with HIV-1 infection who were treated in the parent studies.Based on the number of participants in the parent studies, a maximum of 710 participants (adults, adolescents and children) are expected to potentially rollover into the current study for continued access to CAB LA + RPV LA from study centers in Botswana, Kenya, South Africa, Uganda and Thailand.</span></p>\n
      • other_details_regulatory_notapproved<p>\n Uganda National Drug Authority</p>\n
      • other_details_regulatory_approved<p>\n <strong>Regulatory Authority: </strong></p>\n<p>\n Botswana Medicines & Regulatory Authority</p>\n<p>\n <strong>Country:</strong> Botswana</p>\n<p>\n <strong>Dates of Approval:</strong> 18 June 2024.</p>\n<p>\n <strong>Sites: </strong></p>\n<ol>\n <li>\n Gaborone CRS, Botswana Harvard AIDS Institute Partnership.</li>\n <li>\n Princess Marina Hospital Grounds & Botswana, Molepolole Princess Marina Hospital Grounds, Gaborone, Botswana</li>\n</ol>\n
      • other_details_regulatory_rejected<p>\n None</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration24 Months
      • design_controlled_randomised
      • design_controlled_open
      • design_controlled_single_blind
      • design_controlled_double_blind
      • design_controlled_parallel_group
      • design_controlled_cross_over
      • design_controlled_other
      • design_controlled_specify
      • design_controlled_comparator
      • design_controlled_other_medicinal
      • design_controlled_placebo
      • design_controlled_medicinal_other
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesYes
      • multiple_member_states6
      • number_of_sites5
      • multi_country_listBotswana, Uganda, Thailand & South Africa
      • data_monitoring_committeeNo
      • total_enrolment_per_site40
      • total_participants_worldwide1790
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenYes
      • population_adolescentYes
      • population_above_18Yes
      • population_adultYes
      • population_elderlyYes
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentYes
      • subjects_specifyMinors
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameReena
      • investigator1_middle_name
      • investigator1_family_nameShah
      • investigator1_qualificationMBBS
      • investigator1_professional_addressAga Khan University Hospital
      • investigator1_telephone+254735338003
      • investigator1_emailreena.shah@aku.edu
      • organisations_transferred_Yes
      • number_participants250
      • notification<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n  </p>\n<ul style=\"padding-right: 0px; padding-left: 0px; margin: 0px 0px 10px 25px; color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n <li style=\"line-height: 20px;\">\n Submission done by GSK on 21Oct24</li>\n <li style=\"line-height: 20px;\">\n Sender: Marwa Mohammed</li>\n <li style=\"line-height: 20px;\">\n Subject: Janssen rollover study - TMC278LAHTX4002 (Cabotegravir</li>\n</ul>\n
      • approval_date29-04-2025
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted24-10-2024
      • is_child0
      • unsubmitted1
      • initial_date_submitted24-10-2024
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonReviewer comments have been addressed.
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2025-09-19 13:46:48
      • created2024-07-18 15:11:38
      • total_sites1
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id1110
        • application_id1445
        • given_nameAbraham
        • middle_name
        • family_nameSiika
        • qualificationMD
        • professional_addressabrahamsiika@gmail.com
        • telephone+254721280785
        • emailabrahamsiika@gmail.com
        • created2024-07-18 15:18:51
        • modified2024-10-30 15:46:28
    • SiteDetail(array)
      • 0(array)
        • id1754
        • application_id1445
        • county_id47
        • site_nameAga Khan University Hospital Nairobi
        • physical_address3rd Parklands Avenue, off Limuru Road,
        • contact_details+254 20 366 2107/2109
        • contact_personProf Reena Shah
        • site_capacity(null)
        • misc(null)
        • created2024-07-18 15:18:51
        • modified2024-10-30 15:46:28
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
      • 1(array)
        • id1805
        • application_id1445
        • county_id27
        • site_nameSchool of Medicine, College of Health Sciences, Moi University
        • physical_addressSchool of Medicine, College of Health Sciences, Moi University
        • contact_details+254 53 2060850
        • contact_personProf Abraham Siika Site 10002
        • site_capacity(null)
        • misc(null)
        • created2024-10-19 02:29:42
        • modified2024-10-30 15:46:28
        • County(array)
          • id27
          • county_nameUasin Gishu
          • created2012-06-15 10:25:15
          • modified2012-06-15 10:25:15
      • 2(array)
        • id1806
        • application_id1445
        • county_id35
        • site_nameKenya Medical Research Institute-Walter Reed Program (KEMRI-WRP) Clinical Research Site, Kericho
        • physical_addressHospital Road, P.O. Box 1357. Kericho, Kenya
        • contact_detailsMobile (+254) 703 247 902 / 724 255 623
        • contact_personDr. Josphat Kosgei
        • site_capacity(null)
        • misc(null)
        • created2024-10-19 02:29:42
        • modified2024-10-30 15:46:28
        • County(array)
          • id35
          • county_nameKericho
          • created2012-06-15 10:26:16
          • modified2012-06-15 10:26:16
      • 3(array)
        • id1807
        • application_id1445
        • county_id47
        • site_nameUniversity of Nairobi - Kenyatta National Referral Hospital
        • physical_addressUniversity Way, Nairobi, PO Box 20723-00202, Kenya
        • contact_details+254709824100
        • contact_personDr Loice Achieng
        • site_capacity(null)
        • misc(null)
        • created2024-10-19 02:29:42
        • modified2024-10-30 15:46:28
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
      • 4(array)
        • id1808
        • application_id1445
        • county_id42
        • site_nameUniversity of Nairobi - Jaramogi Oginga Odinga Teaching and Referral Hospital
        • physical_addressJomo Kenyatta Highway, Kaloleni, Kisumu, PO Box 849-40100, Kenya
        • contact_details+254709824100
        • contact_personDr Loice Achieng
        • site_capacity(null)
        • misc(null)
        • created2024-10-19 02:29:42
        • modified2024-10-30 15:46:28
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
    • Sponsor(array)
      • 0(array)
        • id763
        • application_id1445
        • sponsorJanssen-Cilag
        • sponsor_typeIndustry
        • contact_personCatherine Michielsens
        • addressTurnhoutseweg 30 2340 Beerse Belgium
        • telephone_number+3214602111
        • fax_number
        • cell_number+3214602111
        • email_addressra-jcisupportoffice@its.jnj.com
        • created2024-07-18 15:18:51
        • modified2024-10-30 15:46:28
  • 3(array)
    • Application(array)
      • id1481
      • user_id263
      • trial_status_id1
      • abstract_of_study<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n This rollover study will be conducted primarily to enable continued access to CAB LA + RPV LA and also to</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n collect long-term safety and tolerability data as specified in the Schedule of Activities in</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n participants who completed the parent studies and who at the time of rollover, experience and are</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n expected to continue to experience clinical benefit from the regimen, and have no other access to</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n locally available CAB LA + RPV LA.</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n At the time of rollover, the investigator should assess whether the participant still benefit</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n clinically from CAB LA + RPV LA treatment according to the antiviral activity and safety criteria</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n as set out in the protocol of the parent study that the participant was participating in prior to this</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n rollover study. The investigator should also be confident that the participant is expected to continue</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n to experience clinical benefit from CAB LA + RPV LA treatment.</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n Participation in the rollover study is voluntary, and the decision to participate must be made jointly</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n by the investigator and the participant or legally acceptable representative. Participants who do not</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n opt to transition to the rollover study at the end of the CAREs study will be switched to SOC ART</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n per local regulations and availability.</p>\n
      • study_title<p>\n A Phase 4, Open-Label, Rollover Study to Provide Continued Access to Cabotegravir Long-acting Injection and Rilpivirine Long-acting Injection to Participants Living with Human Immunodeficiency Virus Type 1 (HIV-1) Infection Who Participated in Long-acting Combination Therapy Studies</p>\n
      • laymans_summary<p>\n <span style=\"color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">Cabotegravir (CAB) is a potent integrase strand transfer inhibitor (INSTI) with attributes allowing formulation and delivery as a long-acting (LA) parenteral product. Rilpivirine (RPV), also formulated as a LA product, is a diarylpyrimidine derivative and a potent non-nucleoside reverse transcriptase inhibitor (NNRTI) with in vitro activity against wild type HIV-1 and select NNRTI-resistant mutants. The combination of CAB LA and RPV LA has been shown in clinical trials in virologically suppressed adults living with HIV to be safe, well-tolerated and efficacious as a complete injectable antiretroviral regimen. This study enables continued CAB LA + RPV LA access to participants who were included in the clinical development studies for CAB LA + RPV LA (IMPAACT 2017 [MOCHA], IMPAACT 2036 [CRAYON], IMPAACT 2040 [CREATE], TMC278LAHTX3002 [CARES], TMC278LAHTX3005 [IMPALA], in the following sections referred to as the parent studies) and who continue to benefit clinically from the regimen but do not have access to locally available CAB LA + RPV LA to continue treatment. The rollover study will be reviewed periodically to evaluate other access options. </span></p>\n
      • short_titleCabotegravir + Rilpivirine Inj
      • protocol_noECCT/24/10/04
      • version_noOriginal Version
      • date_of_protocol12-01-2024
      • study_drugCabotegravir + Rilpivirine Inj
      • disease_conditionHIV AIDS
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device0
      • product_type_chemical_nameTMC 278
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressamina.salim@iqvia.com
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter0
      • applicant_statement1
      • applicant_participating_countries(null)
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample0
      • applicant_gcp_training1
      • applicant_dsmb_charter0
      • applicant_detailed_budget1
      • applicant_indemnity_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan1
      • applicant_contractual_agreement1
      • declaration_applicantJoyce Chelulei
      • declaration_date123-10-2024
      • declaration_principal_investigatorDr. Josphat Kosgei
      • declaration_date223-10-2024
      • placebo_presentNo
      • study_objectives<div>\n  </div>\n<div>\n <table class=\"table table-condensed\" font-size:=\"\" style=\"max-width: 100%; border-collapse: collapse; border-spacing: 0px; width: 917.271px; margin-bottom: 20px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <tbody>\n <tr>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top-style: solid; border-top-color: rgb(221, 221, 221);\">\n <p style=\"margin: 0px 0px 10px;\">\n Primary Objective</p>\n <p style=\"margin: 0px 0px 10px;\">\n The primary objective of the study is to provide continued CAB LA + RPV LA access to participants who were enrolled and treated with CAB LA + RPV LA in the parent studies, and who, at the time of rollover, experience and are expected to continue to experience clinical benefit from this treatment.</p>\n <p style=\"margin: 0px 0px 10px;\">\n  </p>\n <p style=\"margin: 0px 0px 10px;\">\n Secondary Objective</p>\n <p style=\"margin: 0px 0px 10px;\">\n The secondary objective is to assess the long-term safety and tolerability of CAB LA + RPV LA by evaluating the incidence of serious adverse events (SAEs), pregnancies, adverse events (AEs) leading to discontinuation of CAB LA + RPV LA and AEs considered to be related to the study intervention.</p>\n </td>\n </tr>\n </tbody>\n </table>\n</div>\n<p>\n  </p>\n
      • principal_inclusion_criteria<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 1. Participants (or their legally acceptable representative) must sign an ICF indicating that they understand the purpose of, and procedures required for the study and are willing to participate in the study. Assent is also required of children capable of understanding the nature of the study (in keeping with local regulations) as described in Section 10.2.3. TMC278(rilpivirine) Clinical Protocol TMC278LAHTX4002 Original CONFIDENTIAL –FOIA Exemptions Apply in U.S. 15 Status: Approved, Date: 12 January 2024</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 2. Participants living with HIV-1 infection who were treated with CAB LA + RPV LA in any of the following parent studies: TMC278LAHTX3002 (CARES), TMC278LAHTX3005 (IMPALA), IMPAACT 2017 (MOCHA), IMPAACT 2036 (CRAYON), IMPAACT 2040 (CREATE), and completed the protocol-defined treatment period.</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 3. Has benefited clinically from treatment with CAB LA + RPV LA in the opinion of the investigator and will continue to benefit clinically from this intervention.</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 4. Must be able and willing to comply with the rollover protocol requirements.</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 5. Participant’s general medical condition, in the opinion of the investigator, does not interfere with participation in this study.</p>\n
      • principal_exclusion_criteria<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Any potential participant who meets any of the following criteria will be excluded from participating in the study:</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 1. Participants using disallowed concomitant treatment (see Section 6.9).</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 2. Participants who were withdrawn from the previous parent study with CAB LA + RPV LA that they were participating in prior to this rollover study, based on any of the mandatory withdrawal criteria.</p>\n
      • primary_end_points<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n The end of study is considered as the last visit for the last participant in the study. The final data from the study site will be sent to the sponsor (or designee) after completion of the final participant visit at that study site, in the time frame specified in the Clinical Trial Agreement.</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Participants who prematurely discontinue study intervention for any reason before study completion can be considered to have completed the study if they have completed all the scheduled assessments at that time-point.</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy1
      • scope_safety0
      • scope_efficacy0
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use1
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p style=\"margin-left:.5pt;\">\n The U.S. Army Medical Research Directorate-Africa (USAMRD-A) is a Special Foreign Activity of the Walter Reed Army Institute of Research (WRAIR), Washington, DC. USAMRD-</p>\n<p style=\"margin-left:.5pt;\">\n K is affiliated through a Cooperative Agreement with the Kenya Medical Research Institute (KEMRI). The unit was activated on a temporary basis in 1969 at the invitation of the Government of Kenya to study trypanosomiasis. The success of that initial venture led to the establishment of a permanent activity in 1973. Over the past 46 years, research has been conducted on malaria, polio, trypanosomiasis, leishmaniasis, entomology, HIV/AIDS, enteric diseases and arboviruses, with more than 250 manuscripts published. Kericho is located among the African Highlands in the Kenya’s Rift Valley region and well known for the growing of tea that forms the rolling “seas of green” within the tea plantations. The primary industry in this region is tea farming, with two large international tea companies namely Finlay’s Kenya Ltd. and Unilever Tea Kenya Ltd. being centered in Kericho County. Income in Kericho comes mainly from agricultural activities, with about 40-50% of the population living below the poverty line. The annual national gross domestic product per capita in 2005 averaged Kenyan shillings (Kshs) 35,045 (equivalent to 350.45 United States dollar (USD) at current exchange rates of 1 USD = Ksh 100). According to 2019 population census, Kericho County has a population of 901,777 and an area of 2,111 km2 , with a population density of 365.40 persons/km2 . In Kenya, the age of majority (i.e. legal age of recognized adulthood or independence) is 18 years. The Kenyan national literacy level according the Kenya Adult Literacy Survey report published in March 2007 by the Kenya National Bureau of Statistics was 64%. In Kericho, the literacy level is 74.3% in men and 68.9% in women. The healthcare system in the larger Kericho area (southern Rift Valley) is primarily provided by the government through a network of public hospitals, health centers, and dispensaries ran by the Kenya Ministry of Health. The government health facilities do not charge for treatment but levy a small fee for facility maintenance, which can be waived for those not able to pay. In addition to government health care facilities, there are a few faith based and private health care facilities providing services at a small fee. Access to most health care facilities is good given that there exists a fairly reliable public transport system in the region. The site has a long-standing experience in conducting several studies including clinical trials, ranging from therapeutics that included a study of the safety and impact of broadly neutralizing monoclonal antibody therapy with VRC01 on viremia in acute HIV infection, alone or in combination with antiretroviral therapy (ART), vaccines (HIV, Polio, Ebola, Shigella) and cohort studies. The clinical trials range from phase I to IV with age ranges from birth to the elderly, some of which are randomized double blind, placebo controlled and United States Investigational New Drug (IND)/ Food and Drug Administration (FDA)- regulated. The Kericho CRC is equipped with two emergency rooms with equipment and medications to provide immediate emergency care in the event of emergencies and provisions (resuscitation equipment) are in place for immediate resuscitation on site. Additionally, the Kericho site has a standby, fully equipped ambulance for evacuation of participants for more specialized care when necessary. The study staff (clinicians/nurses) are trained on handling emergencies. For inpatient services, participants will be hospitalized at Unilever Tea Kenya (UTK) Central Hospital which is a private company facility owned by the UTK tea company. The site has been using UTK hospital as a satellite site for inpatient admissions of participants requiring inpatient services. The hospital is located about two kilometers from the CRC and has both outpatient and inpatient services.</p>\n
      • other_details_explanation<p>\n <span font-size:=\"\" style=\"color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">This is a Phase 4, non-randomized, open-label, multicenter, multicountry, rollover study in participants living with HIV-1 infection who were treated in the parent studies.Based on the number of participants in the parent studies, a maximum of 710 participants (adults, adolescents and children) are expected to potentially rollover into the current study for continued access to CAB LA + RPV LA from study centers in Botswana, Kenya, South Africa, Uganda and Thailand.</span></p>\n
      • other_details_regulatory_notapproved<p>\n Uganda National Drug Authority</p>\n
      • other_details_regulatory_approved<p>\n <strong>Regulatory Authority:</strong></p>\n<p>\n Botswana Medicines & Regulatory Authority</p>\n<p>\n <strong>Country:</strong> Botswana</p>\n<p>\n <strong>Dates of Approval:</strong> 18 June 2024.</p>\n<p>\n <strong>Sites:</strong></p>\n<ol>\n <li>\n Gaborone CRS, Botswana Harvard AIDS Institute Partnership.</li>\n <li>\n Princess Marina Hospital Grounds & Botswana, Molepolole Princess Marina Hospital Grounds, Gaborone, Botswana</li>\n</ol>\n
      • other_details_regulatory_rejected<p>\n None</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration24 Months
      • design_controlled_randomised
      • design_controlled_open
      • design_controlled_single_blind
      • design_controlled_double_blind
      • design_controlled_parallel_group
      • design_controlled_cross_over
      • design_controlled_other
      • design_controlled_specify
      • design_controlled_comparator
      • design_controlled_other_medicinal
      • design_controlled_placebo
      • design_controlled_medicinal_other
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesYes
      • multiple_member_states6
      • number_of_sites5
      • multi_country_listBotswana, Uganda, Thailand, South Africa
      • data_monitoring_committeeNo
      • total_enrolment_per_site40
      • total_participants_worldwide1790
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenYes
      • population_adolescentYes
      • population_above_18Yes
      • population_adultYes
      • population_elderlyYes
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentYes
      • subjects_specifyMinors
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameReena
      • investigator1_middle_name
      • investigator1_family_nameShah
      • investigator1_qualificationMBBS
      • investigator1_professional_addressAga Khan University Hospital
      • investigator1_telephone+254735338003
      • investigator1_emailreena.shah@aku.edu
      • organisations_transferred_Yes
      • number_participants250
      • notification<p>\n Please find below sponsor information regarding Cabotegravir-related files submission status sent on email as per sponsor request. </p>\n<ul>\n <li>\n Submission done by GSK on 21Oct24</li>\n <li>\n Sender: Marwa Mohammed</li>\n <li>\n Subject: Janssen rollover study - TMC278LAHTX4002 (Cabotegravir</li>\n</ul>\n
      • approval_date30-04-2025
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted24-10-2024
      • is_child0
      • unsubmitted1
      • initial_date_submitted24-10-2024
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonReviewer comments have been addressed.
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2025-09-19 13:48:35
      • created2024-10-19 01:40:38
      • total_sites1
      • ecitizen_invoice324402
    • InvestigatorContact(array)
      • 0(array)
        • id1180
        • application_id1481
        • given_nameJosphat
        • middle_name
        • family_nameKosgei
        • qualificationMD
        • professional_addressKenya Medical Research Institute/Walter Reed Project Clinical Research Centre
        • telephone0729110122
        • emailJosphat.Kosgei@usamru-k.org
        • created2024-10-19 01:41:56
        • modified2025-04-30 15:52:42
    • SiteDetail(array)
      • 0(array)
        • id1804
        • application_id1481
        • county_id35
        • site_nameKenya Medical Research Institute/Walter Reed Project Clinical Research Centre
        • physical_addressOff Hospital Road, Kericho
        • contact_details P.O.BOX 1357-20200
        • contact_personDr. Josphat Kosgei
        • site_capacity(null)
        • misc(null)
        • created2024-10-19 01:41:56
        • modified2025-04-30 15:52:42
        • County(array)
          • id35
          • county_nameKericho
          • created2012-06-15 10:26:16
          • modified2012-06-15 10:26:16
      • 1(array)
        • id1809
        • application_id1481
        • county_id27
        • site_nameSchool of Medicine, College of Health Sciences, Moi University
        • physical_addressSchool of Medicine, College of Health Sciences, Moi University
        • contact_details+254 53 2060850
        • contact_personProf Abraham Siika Site 10002
        • site_capacity(null)
        • misc(null)
        • created2024-10-19 02:43:04
        • modified2025-04-30 15:52:42
        • County(array)
          • id27
          • county_nameUasin Gishu
          • created2012-06-15 10:25:15
          • modified2012-06-15 10:25:15
      • 2(array)
        • id1810
        • application_id1481
        • county_id47
        • site_nameAga Khan University Hospital Nairobi
        • physical_address3rd Parklands Avenue, off Limuru Road
        • contact_details+254 20 366 2107/2109
        • contact_personProf Reena Shah
        • site_capacity(null)
        • misc(null)
        • created2024-10-19 02:43:04
        • modified2025-04-30 15:52:42
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
      • 3(array)
        • id1811
        • application_id1481
        • county_id47
        • site_nameUniversity of Nairobi - Kenyatta National Referral Hospital
        • physical_addressUniversity Way, Nairobi, PO Box 20723-00202, Kenya
        • contact_details+254709824100
        • contact_personDr Loice Achieng
        • site_capacity(null)
        • misc(null)
        • created2024-10-19 02:43:04
        • modified2025-04-30 15:52:42
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
      • 4(array)
        • id1812
        • application_id1481
        • county_id42
        • site_nameUniversity of Nairobi - Jaramogi Oginga Odinga Teaching and Referral Hospital
        • physical_addressJomo Kenyatta Highway, Kaloleni, Kisumu, PO Box 849-40100, Kenya
        • contact_details+254709824100
        • contact_personDr Loice Achieng
        • site_capacity(null)
        • misc(null)
        • created2024-10-19 02:43:04
        • modified2025-04-30 15:52:42
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
    • Sponsor(array)
      • 0(array)
        • id789
        • application_id1481
        • sponsorJanssen-Cilag
        • sponsor_typeIndustry
        • contact_personCatherine Michielsens
        • addressTurnhoutseweg 30 2340 Beerse Belgium
        • telephone_number+3214602111
        • fax_number
        • cell_number+3214602111
        • email_addressra-jcisupportoffice@its.jnj.com
        • created2024-10-19 01:41:56
        • modified2025-04-30 15:52:42
  • 4(array)
    • Application(array)
      • id1474
      • user_id263
      • trial_status_id1
      • abstract_of_study<div>\n Early and accurate diagnosis of an infectious disease such as HIV, TB and malaria is very important in helping control the burden the such an infectious disease. Early andaccurate diagnosis enables early initiation of treatment before the start of complications.</div>\n<div>\n The current mainstay of diagnosis in all these infectious diseases involve invasive techniques and which do not give real time results. The mainstay of malaria, HIV and TB diagnosis has been blood smear for malaria microscopy, HIV antibody testing and sputum for microscopy (acid fast bacilli) and culture or gene expert respectively. The need for waiting time to get the results makes the diagnostic tests above not very useful for screening, especially in the community.</div>\n<div>\n As a consequence of the unmet need for an ideal screening test for these highly prevalent diseases, EDE research institute is investigating a device, that has a potential to diagnose malaria, TB and HIV in both asymptomatic and symptomatic individuals.</div>\n<div>\n This is a multinational, multicenter, cross-sectional observational study in which approximately 2320 eligible participants, male and female, aged 18 years and above will be recruited in 3 groups. We propose to recruit at about 500 participants, 18 years and above at the ACTU site. The duration of participation for each participant will be approximately 1 day, inclusive of recruitment and follow up of the participants until study conclusion.</div>\n<div>\n All statistical analyses described in the main protocol will be applied based on the same methodology independently, unless otherwise specified.</div>\n<div>\n The publication of the results of the trial will be done in peer reviewed scientific journals in accordance with the governing clinical trial agreement, presented at scientific conferences and findings communicated to the local community through the Community Health Volunteers, Ministries of Health. Individual participants may also be reached and provided with the information if they wish to receive it individually.</div>\n<div>\n The data obtained in this study will be used to validate the EDE scanner for the diagnosis of malaria, tuberculosis and HIV.</div>\n
      • study_title<p>\n A non-interventional clinical validation study of the Exponential Deep Examination (EDE) scanner in the detection of human immunodeficiency virus (HIV), tuberculosis (TB) and malaria</p>\n
      • laymans_summary<div>\n Exponential Deep Examination (EDE) scanner is an innovative device designed to detect infectious diseases and antimicrobial resistance, developed by the parent company of Servizi EDE Research LLC, which has been carrying out research and scouting technology for more than 10 years, developing, among the others, a technology for noninvasive genome detection. Such technology can detect electromagnetic (EM) waves from individuals within a 2–5 meter radius. As EM waves differ among healthy (noninfected) versus infected individuals due to presence of pathogenic DNA/RNA sequences, the technology classifies these EM waves based on their spectral signatures and subsequently identifies the pathogen based on its corresponding sequence.</div>\n<div>\n The technology researched and fine-tuned by the parent company of Servizi EDE Research LLC comprises three main elements:</div>\n<div>\n (1) An EDE detector (sensor) to measure EM waves;</div>\n<div>\n (2) A portable targeting device: Android based device (smartphone) connected to the internet to transmit information and point to a certain individual and display</div>\n<div>\n information; and</div>\n<div>\n (3) A machine learning (ML) model to identify the spectral signature compatible with the specific pathogen.</div>\n<div>\n The same technology was used by the parent company of Servizi EDE Research LLC as a component to develop and fine-tune another type of scanner, which demonstrated high accuracy in detecting the Coronavirus Disease 2019 (COVID-19) (i.e., the COVID-19 EDE scanner). When tested in the Emirate of Abu Dhabi in the United Arab Emirates (UAE), the COVID-19 EDE scanner showed device sensitivity and specificity of 96.7% and 98.12%, respectively, against the gold standard COVID-19 polymerase chain reaction (PCR) test. Moreover, similar results were shown in a study conducted by the Abu Dhabi Health Services Company (SEHA) and Union 71 laboratory testing firm, whereby analysis of 1,093 patient samples yielded a sensitivity and specificity of 93.5% and 83.0%, respectively, in the detection of COVID-19 using the COVID-19 EDE scanner.</div>\n<div>\n Based on these data, the Health Department of Abu Dhabi approved the use of COVID-19 EDE scanner as a screening technology in the detection of COVID-19, whereby individuals screened positive for COVID-19 via the scanner would subsequently undergo RT-PCR testing to confirm the diagnosis of COVID-19. The COVID-19 EDE Scanner was widely used as a mandatory screening tool to detect COVID-19 at land/air entry points, shopping malls and residential areas in Abu Dhabi during the COVID-19 pandemic.</div>\n<div>\n The EDE scanner has the potential to detect other pathogens as well, including human immunodeficiency virus (HIV), tuberculosis (TB), and hepatitis C (HCV), as</div>\n<div>\n demonstrated through a preliminary study by Servizi EDE Research LLC (100% sensitivity and specificity in detection of HIV, TB, and HCV). This preliminary study was conducted among 74 patients from hospitals across the UAE that included patients suspected of HIV as well as confirmed cases of HCV and TB. The EDE scanner successfully detected all the suspected and symptomatic patients with HIV, HCV, and TB, as confirmed against the standard diagnostic tests performed for each of these infections (HIV: HIV viral load and HIV antibody test; HCV: anti-HCV antibody test and nucleic acid test; TB: acid fast bacilli test). Furthermore, EDE scanner may be used to detect antimicrobial resistance. Thus, with prospects to detect a wide range of pathogens and antimicrobial resistance, the EDE scanner has the potential to be used in various settings, including visa screening centers, hospitals, clinics, laboratories, airports, malls, land/air entry points, as well as for other commercial purposes.</div>\n<div>\n Unique features of the EDE scanner include its ability to generate results in real-time (immediately), and its non-invasiveness (no direct contact is required). The device can be used as a screening tool to prompt further diagnostic testing. Such novel diagnostic screening technology is even more important in countries with limited resources and limited access to conventional diagnostic laboratory infrastructure. These technological advancements may reduce the existing gap between diagnostic needs and diagnostic access especially in the middle- and low- income countries (such as African countries), where despite the substantial burden of infectious diseases, only 19% of patients have access to appropriate diagnostics at the primary health care level.</div>\n<div>\n The African continent bears the largest burden of infectious diseases worldwide. Of the estimated 10 million deaths globally per year caused by infectious diseases, the majority occur in Africa. Key contributors to this excessive burden include widespread HIV, malaria, and TB infections, which together account for nearly over 1.2 million deaths per year on the continent. Within the continent, HIV and malaria are highly prevalent across South Africa and Kenya, which are also among the 30 countries worldwide with high burden of TB and MDR-TB.</div>\n
      • short_titleEDE Scanner Study
      • protocol_noECCT/24/10/03
      • version_no1.1
      • date_of_protocol17-07-2024
      • study_drugN/A
      • disease_conditionMalaria, Tuberculosis, HIV and Hepatitis C virus
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
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      • product_type_medical_device1
      • product_type_chemical_name
      • product_type_medical_device_nameEDE scanner
      • comparatorNo
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      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressamina.salim@iqvia.com
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      • declaration_applicantElizabeth Miron
      • declaration_date114-10-2024
      • declaration_principal_investigatorBernhards Ogutu- NPI
      • declaration_date214-10-2024
      • placebo_presentNo
      • study_objectives<div>\n <strong>Primary objective</strong></div>\n<div>\n To assess the sensitivity, specificity, PPV, and NPV of EDE scanner in the detection of infectious diseases of interest (HIV, TB,</div>\n<div>\n malaria)</div>\n<div>\n  </div>\n<div>\n <strong>Secondary objective</strong></div>\n<div>\n To determine the frequency of symptoms (at enrollment) among patients screened positive and screened negative via EDE</div>\n<div>\n scanner, for each infectious disease of interest (HIV, TB, malaria), among patients with confirmed disease*</div>\n<div>\n  </div>\n<div>\n <strong>Exploratory objectives</strong></div>\n<div>\n To assess the sensitivity, specificity, PPV, and NPV of EDE scanner in the detection of MDR-TB.</div>\n<div>\n To assess the sensitivity, specificity, PPV, and NPV of EDE scanner in the detection of HCV.</div>\n
      • principal_inclusion_criteria<div>\n <strong>Inclusion criteria</strong></div>\n<div>\n <strong>For Group 1 (symptomatic patients suspected of HIV/TB/malaria/HCV):</strong></div>\n<div>\n • Male or female, aged ≥18 years</div>\n<div>\n • Asymptomatic/symptomatic patients suspected of HIV, or symptomatic patients suspected of TB, malaria, or HCV based on</div>\n<div>\n physician’s clinical evaluation, which may include laboratory (eg, liver function tests, CBC) or radiological (eg, chest X-ray)</div>\n<div>\n tests per routine clinical practice</div>\n<div>\n • Patient agrees to undergo the non-invasive EDE scanner test and standard diagnostic testing for the respective infectious</div>\n<div>\n disease (HIV/TB/malaria/HCV) - per routine standard of care, in parallel</div>\n<div>\n • Provision of signed informed consent For Group 2 (healthy participants):</div>\n<div>\n • Male or female, aged ≥18 years</div>\n<div>\n • Healthy participant, as determined by physician’s judgment</div>\n<div>\n • Participant undergoing routine blood test as per standard of care</div>\n<div>\n • Participant agrees to undergo non-invasive EDE scanner test</div>\n<div>\n • Participant permits use of the routine blood sample to conduct a standard diagnostic test for HIV, malaria, or HCV; or,</div>\n<div>\n participant agrees to provide a sputum sample to conduct a standard diagnostic test for TB</div>\n<div>\n • No evidence of active infectious disease or any infectious disease in the past 8 weeks</div>\n<div>\n • No history of any of the following in the past 6 months (at minimum): close contact with infected patients or infectious</div>\n<div>\n disease department, open/unprotected relations, drug abuse, blood transfusions</div>\n<div>\n • Provision of signed informed consent</div>\n<div>\n For Group 3 (suspected MDR-TB patients):</div>\n<div>\n • Male or female, aged ≥18 years</div>\n<div>\n • Patients with documented pulmonary TB due to strains of Mycobacterium tuberculosis, currently on TB treatment as per</div>\n<div>\n routine clinical practice and suspected of MDR-TB based on physician’s clinical evaluation (eg, lack of treatment response to</div>\n<div>\n both isoniazid and rifampicin)</div>\n<div>\n • Patient agrees to undergo the non-invasive EDE scanner test and standard diagnostic testing for MDR TB (per routine</div>\n<div>\n standard of care), in parallel</div>\n<div>\n • Provision of signed informed consent</div>\n<div>\n <table align=\"left\" cellpadding=\"0\" cellspacing=\"0\" hspace=\"0\" vspace=\"0\">\n <tbody>\n <tr>\n <td align=\"left\">\n <p>\n <u>For Group 2 (healthy participants):</u></p>\n <p style=\"margin-left:.5in;\">\n ·       Male or female, aged ≥18 years</p>\n <p style=\"margin-left:.5in;\">\n ·       Healthy participant, as determined by physician’s judgment</p>\n <p style=\"margin-left:.5in;\">\n ·       Participant undergoing routine blood test as per standard of care</p>\n <p>\n ·       Participant agrees to undergo non-invasive EDE scanner test</p>\n <p>\n ·       Participant permits use of the routine blood sample to conduct a standard diagnostic test for HIV, malaria, or HCV; or, participant agrees to provide a sputum sample to conduct a standard diagnostic test for TB</p>\n <p style=\"margin-left:.5in;\">\n ·       No evidence of active infectious disease or any infectious disease in the past 8 weeks</p>\n <p style=\"margin-left:.5in;\">\n ·       No history of any of the following in the past 6 months (at minimum): close contact with infected patients or infectious disease department, open/unprotected relations, drug abuse, blood transfusions</p>\n </td>\n </tr>\n </tbody>\n </table>\n <div style=\"clear:both;\">\n Provision of signed informed consent</div>\n</div>\n<table align=\"left\" cellpadding=\"0\" cellspacing=\"0\" hspace=\"0\" vspace=\"0\">\n <tbody>\n <tr>\n <td align=\"left\">\n <p>\n <u>For Group 3 (suspected MDR-TB patients):</u></p>\n <ul>\n <li>\n Male or female, aged ≥18 years</li>\n <li>\n Patients with documented pulmonary TB due to strains of <em>Mycobacterium tuberculosis, </em>currently on TB treatment as per routine clinical practice and suspected of MDR-TB based on physician’s clinical evaluation (eg, lack of treatment response to both isoniazid and rifampicin)</li>\n <li>\n Patient agrees to undergo the non-invasive EDE scanner test and standard diagnostic testing for MDR-TB (per routine standard of care), in parallel</li>\n <li>\n Provision of signed informed consent</li>\n </ul>\n </td>\n </tr>\n </tbody>\n</table>\n<div style=\"clear:both;\">\n  </div>\n
      • principal_exclusion_criteria<table align=\"left\" cellpadding=\"0\" cellspacing=\"0\" hspace=\"0\" vspace=\"0\">\n <tbody>\n <tr>\n <td align=\"left\">\n <p>\n <strong><em>Exclusion criteria</em></strong></p>\n <p>\n <u>For Group 1 (symptomatic patients suspected of HIV/TB/malaria/HCV):</u></p>\n <ul>\n <li>\n Current or previous history of treatment for HIV, TB, malaria, or HCV</li>\n </ul>\n <p style=\"margin-left:.5in;\">\n ·       Patients suspected to be co-infected with more than one of the infectious diseases of interest (HIV/TB/malaria/HCV)</p>\n <ul>\n <li>\n Current or previous participation in any investigational drug or medical device study in the past 3 months</li>\n <li>\n Patients on any concomitant antibiotic or antiviral treatment</li>\n </ul>\n <p>\n <u>For Group 2 (healthy participants):</u></p>\n <ul>\n <li>\n Current or previous participation in any investigational drug or medical device study in the past 3 months</li>\n <li>\n Participants on any concomitant antibiotic or antiviral treatment</li>\n </ul>\n <p>\n <u>For Group 3 (suspected MDR-TB patients):</u></p>\n <ul>\n <li>\n Previous history of treatment for MDR-TB or extensive drug resistance TB (XDR-TB)</li>\n <li>\n Current or previous participation in any investigational drug or medical device study in the past 3 months</li>\n </ul>\n </td>\n </tr>\n </tbody>\n</table>\n<div style=\"clear:both;\">\n  </div>\n<p>\n Patients on any concomitant antibiotic or antiviral treatment</p>\n
      • primary_end_points<div>\n Sensitivity, specificity (with 95% CI), PPV, and NPV of EDE scanner compared with reference standard diagnostic tests in the detection of infectious diseases of interest (HIV, TB, malaria).</div>\n
      • scope_diagnosis1
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety0
      • scope_efficacy0
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other1
      • trial_other_specifyObservational Study
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<div>\n  </div>\n<div>\n <strong>Site Siaya Clinical Trials Annex</strong></div>\n<div>\n 1. PI Prof. Videlis Nduba</div>\n<div>\n 2. Sub-Investigators</div>\n<div>\n Dr Mercy Muderi Mwale - Medical Officer</div>\n<div>\n Dr. Mike Odoyo: Medical Officer</div>\n<div>\n 3. Pharmacists</div>\n<div>\n Dr. Ian Mwangi</div>\n<div>\n Emily Naiserian</div>\n<div>\n  </div>\n<div>\n <strong>Ahero Clinical Trials Unit</strong></div>\n<div>\n 1. PI Dr Bernhards Nduba</div>\n<div>\n 2. Sub-Investigators.</div>\n<div>\n Dr. John Orimbo</div>\n<div>\n Dr. Fredrick Olewe</div>\n<div>\n Dr. Godfrey Allan Otieno</div>\n<div>\n Dr. John Michael Ong’echa</div>\n<div>\n 3. Pharmacists</div>\n<div>\n Dr. Ruth Wasuna</div>\n<div>\n Dr. Simeon Onyango</div>\n<div>\n  </div>\n<div>\n <div>\n <strong>VIBRI Site</strong></div>\n <div>\n <br />\n <div>\n 1. PI Dr. Lucas Otieno Tina, MBChB MSc. DLSHTM</div>\n <div>\n 2. Sub-Investigators- Dr. Walter Otieno, MBChB, MMED (Paeds), PhD</div>\n <div>\n Dr. Antony Oindo, MBChB</div>\n <div>\n Dr. Kenson Nyolmo Kipchumba, MBChB</div>\n <div>\n Dr. Diana Odhiambo, MBChB, MBA, MPH</div>\n <div>\n Dr. Grace Lanoi, MBChB, MMED (Paeds)</div>\n 3. Pharmacist: Dr. Melanie Miruka, BPharmI Dr. Lucas Otieno Tina, MBChB MSc. DLSHTM</div>\n <div>\n 2. Sub-Investigators- Dr. Walter Otieno, MBChB, MMED (Paeds), PhD</div>\n <div>\n Dr. Antony Oindo, MBChB</div>\n <div>\n Dr. Kenson Nyolmo Kipchumba, MBChB</div>\n <div>\n Dr. Diana Odhiambo, MBChB, MBA, MPH</div>\n <div>\n Dr. Grace Lanoi, MBChB, MMED (Paeds)</div>\n <div>\n 3. Pharmacist: Dr. Melanie Miruka, BPharm</div>\n</div>\n<p>\n  </p>\n
      • other_details_explanation<div>\n The Study Primary Objective is to assess the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of EDE scanner in the detection of infectious Sensitivity, specificity (with 95% CI), PPV, and NPV of EDE scanner compared with reference standard diseases of interest (HIV, TB, malaria).</div>\n<div>\n The African continent bears the largest burden of infectious diseases worldwide. Of the estimated 10 million deaths globally per year caused by infectious diseases, the majority occur in Africa. Key contributors to this excessive burden include widespread HIV, malaria, and TB infections, which together account for nearly over 1.2 million deaths per year on the continent. Within the continent, HIV and malaria are highly prevalent across South Africa and Kenya, which are also among the 30 countries worldwide with high burden of TB and MDR-TB.</div>\n<div>\n There is no pool of patients in the host country UAE for HIV, Malaria and TB.</div>\n<div>\n A previous study on this device was done in UAE on COVID 19. Protocol Synopsis of this study (protocol EDECOVID02) is included in this application. The study was designed for 5-7 sites and 1500 participants from UAE.</div>\n<div>\n Sponsor also investigated the epidemiological status of tuberculosis (TB), hepatitis C(HCV), and human immunodeficiency virus (HIV), in different hospitals inUAE.</div>\n<div>\n The EDE machine was tested on:</div>\n<div>\n • 14 people who were quarantined in the hospitals and suspected of having HIV.</div>\n<div>\n • 51 cases of Hepatitis C</div>\n<div>\n • 9 cases of TB infection</div>\n
      • other_details_regulatory_notapproved<p>\n None</p>\n
      • other_details_regulatory_approved<p>\n South Africa Health Product Regulatory Authority, approval was granted on 12 Aug 2024 for 2 sites in South Africa</p>\n
      • other_details_regulatory_rejected<p>\n None</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration6-8 months
      • design_controlled_randomised
      • design_controlled_open
      • design_controlled_single_blind
      • design_controlled_double_blind
      • design_controlled_parallel_group
      • design_controlled_cross_over
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      • design_controlled_other_medicinal
      • design_controlled_placebo
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      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
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      • multiple_sites_member_stateYes
      • multiple_countriesYes
      • multiple_member_states2
      • number_of_sites3
      • multi_country_listKenya and South Africa
      • data_monitoring_committeeNo
      • total_enrolment_per_siteA proximately 387 participants will be enrolled per site
      • total_participants_worldwide2320
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyYes
      • gender_female1
      • gender_male1
      • subjects_healthyYes
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenYes
      • subjects_nursing_womenYes
      • subjects_emergency_situationYes
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameBernhards
      • investigator1_middle_name
      • investigator1_family_nameOgutu
      • investigator1_qualificationMBChB MPH
      • investigator1_professional_addressP.O BOX 54-40100 KISUMU
      • investigator1_telephone0733812613
      • investigator1_emailOgutu6@gmail.com
      • organisations_transferred_Yes
      • number_participants1160
      • notification
      • approval_date07-04-2025
      • submitted1
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      • deleted_date(null)
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      • date_submitted14-10-2024
      • is_child0
      • unsubmitted1
      • initial_date_submitted14-10-2024
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      • admin_stopped_reason(null)
      • approved2
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      • modified2025-11-10 13:20:30
      • created2024-10-08 10:21:23
      • total_sites2
      • ecitizen_invoice322203
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        • given_nameVIDELIS
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        • family_nameNduba
        • qualificationMBChB MPH PHD
        • professional_addressP.O BOX 254 NAIROBI
        • telephone0724522474
        • emailvnduba@kemri.go.ke
        • created2024-10-08 10:23:23
        • modified2024-11-14 15:54:49
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        • emailOgutu6@gmail.com
        • created2024-10-08 11:11:02
        • modified2024-11-14 15:54:49
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        • contact_details0733812613
        • contact_personDr Bernhards Ogutu
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          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
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        • contact_details0724522474
        • contact_personProf Videlis Nduba
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        • created2024-10-08 11:36:30
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        • site_nameVICTORIA BIOMEDICAL RESEARCH INSTITUTE
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        • contact_detailsP.O Box 2109, Kisumu, Kenya, Postal Code 40100
        • contact_personLucas Tina
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          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
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        • sponsorServizi EDE Research LLC,
        • sponsor_typeIndustry
        • contact_personSalvatore Spagna
        • addressSharjah Media City, Sharjah, United Arab Emirates
        • telephone_number+971562240274
        • fax_number
        • cell_number+971562240274
        • email_addresssalvo.spagna@ede.ae
        • created2024-10-08 10:23:23
        • modified2024-11-14 15:54:49
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    • 1CORE/Model/Permission.php
    • 2CORE/Model/Model.php
    • 3CORE/Model/BehaviorCollection.php
    • 4CORE/Model/Aro.php
    • 5CORE/Model/AclNode.php
    • 6CORE/Model/Aco.php
    • 7CORE/Model/ModelBehavior.php
  • Network(array)
    • 0CORE/Network/CakeRequest.php
    • 1CORE/Network/CakeResponse.php
  • Other(array)
    • 0CORE/bootstrap.php
    • 1CORE/basics.php
    • 2CORE/Core/App.php
    • 3CORE/Core/Configure.php
    • 4CORE/Core/CakePlugin.php
    • 5CORE/Event/CakeEventListener.php
    • 6CORE/Event/CakeEvent.php
    • 7CORE/Event/CakeEventManager.php
    • 8CORE/Core/Object.php
  • Routing(array)
    • 0CORE/Routing/Dispatcher.php
    • 1CORE/Routing/Filter/AssetDispatcher.php
    • 2CORE/Routing/DispatcherFilter.php
    • 3CORE/Routing/Filter/CacheDispatcher.php
    • 4CORE/Routing/Router.php
    • 5CORE/Routing/Route/CakeRoute.php
    • 6CORE/Routing/Route/PluginShortRoute.php
  • Utility(array)
    • 0CORE/Utility/Hash.php
    • 1CORE/Utility/Inflector.php
    • 2CORE/Utility/ObjectCollection.php
    • 3CORE/Utility/Debugger.php
    • 4CORE/Utility/String.php
    • 5CORE/Utility/ClassRegistry.php
    • 6CORE/Utility/Set.php
    • 7CORE/Utility/Sanitize.php
  • View(array)
    • 0CORE/View/HelperCollection.php
• app(array)
  • Behavior(array)
    • 0APP/Model/Behavior/SoftDeleteBehavior.php
  • Config(array)
    • 0APP/Config/core.php
    • 1APP/Config/bootstrap.php
    • 2APP/Config/routes.php
    • 3APP/Config/database.php
  • Controller(array)
    • 0APP/Controller/ApplicationsController.php
    • 1APP/Controller/AppController.php
  • Model(array)
    • 0APP/Model/AppModel.php
    • 1APP/Model/Application.php
    • 2APP/Model/User.php
    • 3APP/Model/TrialStatus.php
    • 4APP/Model/InvestigatorContact.php
    • 5APP/Model/Sponsor.php
    • 6APP/Model/SiteDetail.php
    • 7APP/Model/County.php
  • Other(array)
    • 0APP/webroot/index.php
• plugins(array)
  • CakePdf(array)
    • Config(array)
      • 0CakePdf/Config/bootstrap.php
      • 1CakePdf/Config/routes.php
  • CakeResque(array)
    • Config(array)
      • 0CakeResque/Config/bootstrap.php
    • Plugin(array)
      • 0CakeResque/Lib/CakeResque.php
      • 1CakeResque/vendor/kamisama/php-resque-ex/lib/Resque.php
      • 2CakeResque/vendor/kamisama/php-resque-ex/lib/Resque/Event.php
      • 3CakeResque/vendor/kamisama/php-resque-ex/lib/Resque/Exception.php
  • DebugKit(array)
    • Component(array)
      • 0DebugKit/Controller/Component/ToolbarComponent.php
    • Plugin(array)
      • 0DebugKit/Lib/DebugMemory.php
      • 1DebugKit/Lib/Panel/HistoryPanel.php
      • 2DebugKit/Lib/DebugPanel.php
      • 3DebugKit/Lib/Panel/SessionPanel.php
      • 4DebugKit/Lib/Panel/RequestPanel.php
      • 5DebugKit/Lib/Panel/SqlLogPanel.php
      • 6DebugKit/Lib/Panel/TimerPanel.php
      • 7DebugKit/Lib/Panel/LogPanel.php
      • 8DebugKit/Lib/Log/Engine/DebugKitLog.php
      • 9DebugKit/Lib/Panel/VariablesPanel.php
      • 10DebugKit/Lib/Panel/EnvironmentPanel.php
      • 11DebugKit/Lib/Panel/IncludePanel.php
      • 12DebugKit/Lib/DebugTimer.php
  • Media(array)
    • Config(array)
      • 0Media/Config/bootstrap.php
    • Plugin(array)
      • 0Media/Lib/mm/src/Mime/Type.php
      • 1Media/Lib/mm/src/Mime/Type/Magic/Adapter/Fileinfo.php
      • 2Media/Lib/mm/src/Mime/Type/Magic/Adapter.php
      • 3Media/Lib/mm/src/Mime/Type/Glob/Adapter/Memory.php
      • 4Media/Lib/mm/src/Mime/Type/Glob/Adapter.php
      • 5Media/Lib/mm/src/Media/Process.php
      • 6Media/Lib/mm/src/Media/Info.php
  • Search(array)
    • Component(array)
      • 0Search/Controller/Component/PrgComponent.php
    • Behavior(array)
      • 0Search/Model/Behavior/SearchableBehavior.php
  • Shim(array)
    • Config(array)
      • 0Shim/Config/bootstrap.php
  • Tools(array)
    • Config(array)
      • 0Tools/Config/bootstrap.php