Request History

• Restore to current request
• applications/index/page:99/sort:study_title/direction:desc/approved:1
• applications/index/page:88/approved:2/sort:study_title/direction:asc
• applications/index/page:90/approved:2/sort:study_title/direction:asc
• applications/index/page:94/approved:2

Session

• Config(array)
  • userAgent9c3d2c89526db53b7b69e8c9faa06145
  • time1746234660
  • countdown10

Request

Cake Params

• plugin(null)
• controllerapplications
• actionindex
• named(array)
  • page99
  • sortprotocol_no
  • directionasc
  • approved1
• pass(empty)
• isAjax(false)
• paging(array)
  • Application(array)
    • page99
    • current5
    • count502
    • prevPage(true)
    • nextPage(true)
    • pageCount101
    • order(array)
      • Application.protocol_noasc
    • limit5
    • options(array)
      • page99
      • order(array)
        • Application.protocol_noasc
      • sortprotocol_no
      • directionasc
    • paramTypenamed

Post data

• Application(array)
  • approved1

Query string

No querystring data.

Cookie

To view Cookies, add CookieComponent to Controller

Current Route

• keys(array)
  • 0controller
  • 1action
• options(empty)
• defaults(array)
  • plugin(null)
• template/:controller/:action/*

Sql Logs

Logs

View Variables

• trial_statuses(array)
  • 1Recruiting
  • 2Not yet recruiting
  • 3Suspended
  • 4Stopped
  • 5Completed
  • 6In follow-up
  • 7Analysing
  • 8Writing-up
  • 9Application withdrawn
• applications(array)
  • 0(array)
    • Application(array)
      • id1474
      • user_id263
      • trial_status_id(null)
      • 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
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical0
      • product_type_medical_device1
      • product_type_chemical_name
      • product_type_medical_device_nameEDE scanner
      • 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_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd0
      • applicant_prev_data1
      • applicant_stability_data0
      • 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_plan0
      • applicant_contractual_agreement1
      • 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
      • 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_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
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted14-10-2024
      • is_child0
      • unsubmitted1
      • initial_date_submitted14-10-2024
      • 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)
      • modified2025-04-07 15:26:34
      • created2024-10-08 10:21:23
      • total_sites2
      • ecitizen_invoice322203
    • InvestigatorContact(array)
      • 0(array)
        • id1171
        • application_id1474
        • given_nameVIDELIS
        • middle_name
        • 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
      • 1(array)
        • id1172
        • application_id1474
        • given_nameBerngards
        • middle_name
        • family_nameOgutu
        • qualificationMBChB MPH
        • professional_addressP.O BOX 54-40100 KISUMU
        • telephone0733812613
        • emailOgutu6@gmail.com
        • created2024-10-08 11:11:02
        • modified2024-11-14 15:54:49
    • SiteDetail(array)
      • 0(array)
        • id1792
        • application_id1474
        • county_id42
        • site_nameAhero Clinical Trials Unit
        • physical_addressAhero clinical trial Unit insite ahero Sub-County Hospital along Kisumu Nairobi highway
        • contact_details0733812613
        • contact_personDr Bernhards Ogutu
        • site_capacity(null)
        • misc(null)
        • created2024-10-08 10:23:23
        • modified2024-11-14 15:54:49
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
      • 1(array)
        • id1793
        • application_id1474
        • county_id41
        • site_nameKEMRI/CRDR Siaya Clinical trials Annex
        • physical_addressSiaya Clinical trials annex Insite Siaya Country referral Hospital
        • contact_details0724522474
        • contact_personProf Videlis Nduba
        • site_capacity(null)
        • misc(null)
        • created2024-10-08 11:36:30
        • modified2024-11-14 15:54:49
        • County(array)
          • id41
          • county_nameSiaya
          • created2012-06-15 10:26:56
          • modified2012-06-15 10:26:56
      • 2(array)
        • id1794
        • application_id1474
        • county_id42
        • site_nameVICTORIA BIOMEDICAL RESEARCH INSTITUTE
        • physical_addressKisumu County Referral Hospital
        • contact_detailsP.O Box 2109, Kisumu, Kenya, Postal Code 40100
        • contact_personLucas Tina
        • site_capacity(null)
        • misc(null)
        • created2024-10-08 11:36:30
        • modified2024-11-14 15:54:49
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
    • Sponsor(array)
      • 0(array)
        • id785
        • application_id1474
        • 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
  • 1(array)
    • Application(array)
      • id1481
      • user_id263
      • trial_status_id(null)
      • 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)
      • modified2025-04-30 17:02:11
      • 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
  • 2(array)
    • Application(array)
      • id1445
      • user_id263
      • trial_status_id(null)
      • 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)
      • modified2025-04-29 11:50:37
      • 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)
      • id1489
      • user_id32
      • trial_status_id(null)
      • abstract_of_study<div>\n <strong>Title:</strong> Delivery strategies for malaria chemoprevention in the post-discharge management of hospitalised children with severe anaemia or severe malaria: cluster and individually randomised controlled implementation trials with nested economic evaluation in Kenya and Benin.</div>\n<div>\n Short Title: PDMC-Saves Lives (PDMC-SL)</div>\n<div>\n <strong>Background and rationale:</strong> In June 2022, the World Health Organization (WHO) recommended PDMC for the post-discharge management of children with severe anaemia in settings with moderate to high perennial malaria transmission to reduce hospital readmissions and deaths after discharge. However, there is no obvious delivery platform for PDMC, unlike for intermittent preventive treatment in infants (IPTi) or pregnant women (IPTp). Furthermore, a potential limitation of PDMC is adherence to the 3-day dosing regimen, which is provided monthly three times after discharge. Therefore, implementation research is urgently needed to support the introduction and scale-up of PDMC. We propose to conduct two implementation trials to evaluate delivery strategies to optimise adherence to PDMC in different contexts: one in East Africa (Kenya) and one in West Africa (Benin). The actual interventions to be evaluated differ between the two trials as they have been co-designed with national stakeholders during an initial formative research stage, conducted under a separate protocol (LSTM Protocol #23-053, KEMRI-SERU #480/4870).</div>\n<div>\n <strong>Aim:</strong> To conduct implementation trials, co-designed with national stakeholders, to evaluate different delivery strategies to optimise health system delivery of PDMC drugs and adherence to PDMC to provide evidence-based data including acceptability, feasibility and cost-effectiveness that are useful to decision-makers.</div>\n<div>\n Study Type: Kenya: A multi-centre, 2-arm, cluster-randomised trial evaluating two health system delivery strategies and a 3-arm nested individually randomised trial evaluating two new intervention strategies to enhance end-user adherence to PDMC compared to the standard of care without adherence strategies. Benin: A multi-centre, 3-arm, individually randomised trial evaluating two intervention strategies to enhance end-user adherence to PDMC compared to a control arm of PDMC without specific adherence support strategies.</div>\n<div>\n <strong>Sites: </strong>Health facilities with blood transfusion services in malaria-endemic areas in Benin and western Kenya.</div>\n<div>\n <div>\n Study Population:</div>\n <div>\n <strong>Clusters (Kenya only) inclusion criteria:</strong> health facilities with blood transfusion services offering in-patient care for children with severe anaemia and severe malaria. Exclusion criteria: primary health facilities without subservient lower-level health facilities. Individuals (Kenya and Benin) inclusion criteria: convalescent children aged <10 years, weighing ≥5 kg admitted with severe anaemia (haemoglobin<5g/dL) or severe malaria; clinically stable, able to take or switch to oral medication; post-transfusion Hb >5g/dL. Exclusion criteria: blood loss due to trauma, malignancy, known bleeding disorders or sickle cell disease, known hypersensitivity to study drug, known heart conditions, non-resident in the study area, previous participation in the study, known need at enrolment for prohibited medication and scheduled surgery during the 4-month course of the study. HIV infection and cotrimoxazole prophylaxis are not exclusion criteria.</div>\n <div>\n <strong>Study Interventions:</strong></div>\n <div>\n Cluster randomised trial (Kenya only): Hospitals will be randomised to one of two delivery platforms for PDMC (A or B). The choice of the two delivery strategies to be evaluated has been informed by formative research conducted under a separate standalone protocol (LSTM Protocol #23-053, KEMRI-SERU #480/4870) and stakeholder engagements. Strategy A comprises delivery of the initial PDMC course at the primary admitting facility two weeks after discharge during a post-discharge follow-up clinic visit. The subsequent 2 courses will be dispensed monthly at the closest health facility. Strategy B comprises delivery of all 3 PDMC courses at the primary admitting facility two weeks after discharge during a post-discharge follow-up clinic visit.</div>\n <div>\n Individually randomised trial (Kenya and Benin): The final choice of the adherence support strategies to be evaluated has been informed by formative research conducted under the same separate standalone protocol. In Kenya, these include: Arm a - SMS reminders to caregivers, Arm b - Community Health Promoter (CHP) support through monthly home visits and Arm c - no reminders (control). In Benin, these include: Arm a- a telephone reminder to the community health worker (CHW)/qualified community health worker (ASCQ); Arm b - regional social mobilisation research and support officer (CRAMS) reminder through monthly visits to CHW/ASCQ; and Arm c - no reminder (control).</div>\n <div>\n All participating children will receive standard in-hospital care for severe anaemia or severe malaria (blood transfusion, often combined parenteral artesunate, followed by a 3-day course of AL whether they initially had malaria or not), which will be started in-hospital as soon as they are able to take oral medication. Many children are likely to receive parenteral antibiotics as well as part of the standard of care.</div>\n <div>\n <strong>Endpoints:</strong> Cluster randomised trial (Kenya only): The primary endpoint will be the proportion of eligible participants who were not prescribed the full 3 courses of dpoints:PDMC. Individually randomised trial (Kenya and Benin): Primary endpoint: proportion of children with incomplete adherence to the 9 doses of PDMC (three courses of 3-day treatments 3x3=9). Secondary endpoints include 1) clinical effectiveness (all-cause and malaria-specific sick-child clinic visits, all-cause and cause-specific readmissions and all-cause mortality by the end of week 14 after discharge, 2) safety (incidence of serious adverse events), 3) cost-effectiveness, and 4) acceptability and feasibility.</div>\n <div>\n <strong>Follow-up procedures:</strong> Children will be followed for 14 weeks (i.e., four weeks after the last PDMC course) through passive surveillance of clinic visits and hospitalisations. Each child will then be seen for an end-of-study visit towards the end of week 14. Children will also be visited at home for unannounced home visits one to three days from the last day of the last dose of each 3-day course of PDMC medication to assess adherence.</div>\n <div>\n Sample size: Cluster randomised trial (Kenya only): Approximately 60 participants per cluster (cluster size will vary between clusters), or approximately 600 overall (300 in each of the two study arms) is estimated to provide over 80% power to detect a risk difference of 20% from 35% in the control arm to 15% in the intervention clusters (RR=0.43), using a two-sided alpha of 0.05, and assuming an intra-cluster correlation coefficient (ICC) of 0.03, a coefficient of variation of 0.39,15% loss to follow-up and small-sample correction to account for the small number of clusters. Individually randomised trial (Kenya and Benin): A sample size of 147 participants in the control arm (c) and 147 in each of the two intervention arms (a and b), totalling 441 participants, would provide 90% power to detect a 50% reduction in the primary endpoint (proportion of children with incomplete adherence to the 9 doses of PDMC) from 36.8% in the control arm to 18.4% (RR=0.50) in any of the two intervention arms using a 1:1:1 allocation after accounting for the multiple comparisons (α = 0.025). A total of 519 participants (173 per arm) will be recruited to allow for a 15% loss to follow-up.</div>\n <div>\n <strong>Data Analysis:</strong> Risk ratios and corresponding 95% confidence intervals will be computed to compare treatment effects using multi-level mixed models (Kenya) or mixed models (Benin) accounting for clustering effects.</div>\n <div>\n <strong>Partners institutions</strong>: IRCB, Benin; KEMRI Kisumu, Kenya; LSTM, UK; Epicentre, France; IRD, France; Centers for Disease Control and Prevention, US; TRUE, Malawi.</div>\n</div>\n<div>\n  </div>\n
      • study_title<p>\n Delivery strategies for malaria chemoprevention in the post-discharge management of hospitalised children with severe anaemia or severe malaria: cluster and individually randomised controlled implementation trials with nested economic evaluation in Kenya and Benin</p>\n
      • laymans_summary<div>\n <strong>Background:</strong> The World Health Organization (WHO) recommended post-discharge malaria chemoprevention (PDMC) in June 2022 for managing children with severe anaemia in areas with moderate to high perennial malaria transmission. The goal is to reduce hospital readmissions and deaths after discharge. However, there is no clear delivery platform for PDMC, and adherence to the 3-day dosing regimen, provided monthly three times after discharge, is a potential limitation. Implementation research is necessary to support the introduction and scale-up of PDMC.</div>\n<div>\n <strong>Aim: </strong>Implementation trials in Kenya and Benin will be co-designed with national stakeholders to evaluate alternative health system delivery strategies for optimizing delivery of PDMC drugs and adherence to PDMC. The trials will provide evidence on the acceptability, feasibility, and cost-effectiveness of each strategy to inform effective implementation and scale-up of PDMC in different country and health system contexts.</div>\n<div>\n <strong>Methods:</strong> The project involves two separate trials, one in each country. Formative research with the Ministries of Health in the two countries and their stakeholders has informed the delivery strategy interventions selected to be evaluated in each trial. In Kenya, a multi-centre, 2-arm cluster randomised trial will compare two “delivery strategies” for the 3 courses of monthly PDMC with dihydroartemisinin-piperaquine (DP). The trial will randomize 10 hospitals (the clusters) to one of two delivery platforms (A and B) in a 1:1 ratio, with the final choice of intervention informed by formative research. The primary endpoint will be the proportion of eligible participants prescribed with incomplete courses of PDMC. A nested 3-arm individually randomised trial involving 600 children ( 200 per arm) will evaluate 3 different “adherence support” strategies, including SMS reminders to caregivers, Community Health Worker (CHW) support through home visits, and a control arm comprising of provision of all 3 PDMC courses by the hospital where the child was admitted i.e. standard of care. The primary endpoint will be the proportion of children with incomplete adherence (i.e. not receiving all 9 doses of PDMC).</div>\n<div>\n Secondary endpoints include clinical effectiveness, cost-effectiveness, acceptability and feasibility, provision of adherence support mechanisms, and linkage to subsequent levels of service provision along the PDMC delivery continuum. All participating children will receive standard in-hospital care for severe anaemia or severe malaria and a 3-day course of artemether-lumefantrine (AL), started in-hospital as soon as they can take oral medication.</div>\n<div>\n In Benin, a 3-arm individually randomised trial involving 519 children (173 per arm) will be conducted to evaluate different “adherence support” strategies only, including: mobile phone reminders to CHW/ASCQ , monthly reminder visits to CHW/ASCQ by the regional social mobilisation research and support officer (CRAMS), and a control arm without any reminder intervention.</div>\n<div>\n LSTM-UK will act as the legal sponsor of the trials in Kenya. The Institut de Recherche Clinique du Bénin (IRCB) will act as the sponsor for the trial in Benin.</div>\n
      • short_titlePDMC-Saves Lives (PDMC-SL)
      • protocol_noECCT/24/12/01
      • version_no1.3
      • date_of_protocol06-09-2024
      • study_drugDihydroartemisinin-piperaquine
      • disease_conditionMalaria
      • 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_nameDihydroartemisinin-piperaquine
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressruth.njoroge@ke.lstmed.ac.uk
      • 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_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. Ruth Njoroge - Pharmacist
      • declaration_date105-12-2024
      • declaration_principal_investigatorDr. Juliet Otieno Awori - Principal Investigator
      • declaration_date205-12-2024
      • placebo_presentNo
      • study_objectives<div>\n <div>\n <strong>Primary Objectives</strong></div>\n</div>\n<div>\n <strong>1. Cluster RCT of health systems delivery mechanism:</strong></div>\n<div>\n - To determine the effectiveness of different delivery strategies to optimise health system delivery of PDMC</div>\n<div>\n <div>\n <strong>2. Individually RCT of end-user adherence support</strong></div>\n <div>\n - To determine the effectiveness of different adherence support strategies to optimise end-user adherence to PDMC</div>\n <div>\n  </div>\n <div>\n <strong>Secondary Objectives</strong></div>\n</div>\n<div>\n <strong>1. Cluster RCT of health systems delivery mechanism:</strong></div>\n<div>\n - To evaluate the adoption of the health system delivery mechanisms and adherence support mechanisms for the 3 courses of PDMC</div>\n<div>\n <div>\n <strong>2. Individually RCT of end-user adherence support:</strong></div>\n <div>\n To determine the clinical effectiveness of the different PDMC delivery strategies (all-cause and malaria-specific readmissions and sick-child clinic visits, all-cause mortality).</div>\n <div>\n 3. To evaluate the effectiveness of the linkage mechanisms between the various health facility levels along the PDMC delivery continuum</div>\n</div>\n<p>\n  </p>\n
      • principal_inclusion_criteria<div>\n 1. Aged <10 years of both sexes</div>\n<div>\n 2. Hospitalised with severe anaemia or severe malaria: Initially hospitalised with haemoglobin <5.0 g/dl or PCV <15%, or requirement for blood transfusion for other clinical reasons on or during admission to the hospital, or severe malaria, defined as a requirement for parenteral artesunate in the opinion of the treating clinician and the presence of microscopy or RDT confirmed Plasmodium infection</div>\n
      • principal_exclusion_criteria<div>\n 1. Recognised specific other causes of severe anaemia (i.e., trauma, haematological malignancy, known bleeding disorders, such as haemophilia)</div>\n<div>\n 2. Sickle cell anaemia/sickle cell disease</div>\n<div>\n 3. Body weight <5 kg</div>\n
      • primary_end_points<div>\n 1. The proportion of participants receiving an incomplete set of PDMC courses</div>\n<div>\n 2. The proportion of participants with incomplete adherence to the 9 doses of PDMC</div>\n
      • scope_diagnosis0
      • scope_prophylaxis1
      • 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_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use1
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<div>\n <strong>INVESTIGATORS AND INSTITUTIONS</strong></div>\n<div>\n <strong>Chief Investigators</strong></div>\n<div>\n Dr Jenny Hill, PhD - Liverpool School of Tropical Medicine (LSTM)</div>\n<div>\n Prof Feiko ter Kuile, MD, PhD - KEMRI/CDC and LSTM</div>\n<div>\n <strong>Country Principal Investigator</strong></div>\n<div>\n Dr Juliet Otieno Awori, MBChB, PhD - Kenya Medical Research Institute (KEMRI), Centre for Global Health Research (CGHR) and CDC Collaboration</div>\n<div>\n <strong>Country Co- Principal Investigator</strong></div>\n<div>\n Dr Simon Kariuki, PhD - Kenya Medical Research Institute (KEMRI), Centre for Global Health Research (CGHR) and CDC Collaboration</div>\n<div>\n <strong>Co-Investigators</strong></div>\n<div>\n Dr Titus Kwambai, MBChB, PhD - Centers for Disease Control and Prevention, Kenya (CDC-Kenya), KEMRI Centre for Global Health Research (CGHR) and CDC Collaboration</div>\n<div>\n Dr. Ruth Njoroge, BPharm, Dr Prisca Oria, PhD - Kenya Medical Research Institute (KEMRI), Centre for Global Health Research (CGHR) and CDC Collaboration</div>\n<div>\n Dr Eve Worrall, PhD, Carole Khairallah, Jenna Hoyt, Dr Tao Chen, MD, MSc, PhD, Amanda McCoy, MSc - Liverpool School of Tropical Medicine (LSTM)</div>\n<div>\n <strong>Collaborators</strong></div>\n<div>\n Dr. Sammy Mahugu, MBChB, MPH,MBA, Ms. Regina Kandie, MSc - Ministry of Health Kenya, National Malaria Control Programe</div>\n<div>\n Dr Valérie Briand, Dr Adrian Luty - Epicentre, Paris, France</div>\n<div>\n Prof Kamija Phiri, MD, PhD; Dr Lucinda Manda-Taylor - Training Research Unit of Excellence, Blantyre, Malawi</div>\n
      • other_details_explanation<p>\n N/A</p>\n
      • other_details_regulatory_notapproved<p>\n N/A</p>\n
      • other_details_regulatory_approved<p>\n N/A</p>\n
      • other_details_regulatory_rejected<p>\n N/A</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration17 months
      • 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_comparatorDiff. delivery strategies
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaHealth facilities with blood transfusion services in malaria-endemic areas in Western Kenya
      • single_site_physical_addressKEMRI-CGHR P.O. Box 1578-40100, Kisumu, Kenya.
      • single_site_contact_personJuliet Otieno Awori
      • single_site_telephone+254721432548
      • multiple_sites_member_stateNo
      • multiple_countriesYes
      • multiple_member_states2
      • number_of_sites
      • multi_country_listKenya\nBenin
      • data_monitoring_committeeYes
      • total_enrolment_per_site600
      • total_participants_worldwide1119
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerYes
      • population_childrenYes
      • population_adolescentNo
      • population_above_18No
      • population_adultNo
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentYes
      • subjects_specifyChildren aged under 10 years
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameFeiko
      • investigator1_middle_nameter
      • investigator1_family_nameKuile
      • investigator1_qualificationMD, PhD
      • investigator1_professional_addressKEMRI CGHR 1578-40100 Kisumu, Kenya
      • investigator1_telephone+254708739228
      • investigator1_emailFeiko.terkuile@lstmed.ac.uk
      • organisations_transferred_No
      • number_participants600
      • notification
      • approval_date16-04-2025
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted05-12-2024
      • is_child0
      • unsubmitted1
      • initial_date_submitted05-12-2024
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonReviewer comments have ben 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)
      • modified2025-04-16 19:37:28
      • created2024-11-18 15:41:01
      • total_sites1
      • ecitizen_invoice330507
    • InvestigatorContact(array)
      • 0(array)
        • id1202
        • application_id1489
        • given_nameJuliet
        • middle_nameOtieno
        • family_nameAwori
        • qualificationMBChB
        • professional_addressKEMRI CGHR 1578-40100 Kisumu, Kenya
        • telephone+254721432548
        • emailJuliet.Otieno@lstmed.ac.uk
        • created2024-12-04 16:37:28
        • modified2025-02-03 10:22:51
      • 1(array)
        • id1203
        • application_id1489
        • given_nameSimon
        • middle_name
        • family_nameKariuki
        • qualificationPhD
        • professional_addressKEMRI CGHR 1578-40100 Kisumu, Kenya
        • telephone+254725389246
        • emailskariuki1578@gmail.com
        • created2024-12-05 11:57:10
        • modified2025-02-03 10:22:51
    • SiteDetail(array)
      • 0(array)
        • id1825
        • application_id1489
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2024-12-04 16:37:28
        • modified2025-02-03 10:22:51
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id795
        • application_id1489
        • sponsorLiverpool School of Tropical Medicine (LSTM
        • sponsor_typeResearch Institution
        • contact_personProf Feiko ter Kuile, MD, PhD
        • addressPembroke Place, Liverpool L3 5QA, UK.
        • telephone_number+44 0151 7053794
        • fax_number
        • cell_number+44 0151 7053794
        • email_addresslstmgov@lstmed.ac.uk
        • created2024-12-04 16:37:28
        • modified2025-02-03 10:22:51
  • 4(array)
    • Application(array)
      • id1492
      • user_id263
      • trial_status_id(null)
      • abstract_of_study<div>\n This is an interventional, multi-national, multi-centre, open-label, phase 3b study in adults (participants ≥ 18 years old), adolescents (participants ≥ 12 to < 18 years old) and children(participants ≥ 11 months to < 12 years old) with sickle cell disease (SCD), with SCD who have been on chronic transfusions to prevent primary stroke or recurrence of stroke (SCDTD), non-transfusion-dependent thalassaemia (NTDT) or transfusion-dependent thalassaemia (TDT).</div>\n<div>\n The purpose of this rollover study is to investigate the long-term safety of etavopivat in participants 11 months of age and older with SCD or thalassaemia who have completed a treatment period in previous etavopivat studies.  Long-term clinical efficacy measures of etavopivat treatment will also be assessed.</div>\n<div>\n Etavopivat is an orally bioavailable, selective activator of erythrocyte pyruvate kinase (PKR), currently under development in clinical studies as a potential treatment for inherited haemoglobinopathies, including SCD and thalassemia</div>\n<div>\n Approximately 325 participants are planned to be enrolled in the study in about 120 sites worldwide. All participants will receive etavopivat. Participants ≥ 12 years old will receive an oral dose of 400 mg QD administered as 2 × 200 mg tablets. Participants < 12 years old will receive an age- and weight-adjusted dose (400 mg QD equivalent dose) administered as granules </div>\n<div>\n  </div>\n
      • study_title<p>\n An open-label, multi-centre, rollover study to characterise long-term safety and efficacy of etavopivat in adults, adolescents and children who have sickle cell disease or thalassaemia and have completed a treatment period in an etavopivat study.</p>\n
      • laymans_summary<div>\n A research study looking at long-term treatment with etavopivat in people with sickle cell disease or thalassaemia.</div>\n<div>\n The purpose of this rollover study is to investigate the long-term safety of etavopivat in participants 11 months of age and older with SCD or thalassaemia who have completed a treatment period in previous etavopivat studies.</div>\n<div>\n <div>\n Long-term clinical efficacy measures of etavopivat treatment will also be assessed. This study will also ensure that participants who are benefiting from etavopivat treatment have prolonged access to the drug in the time before it is commercially available in their country.</div>\n <div>\n Etavopivat is an orally bioavailable, small-molecule activator of pyruvate kinase red blood cell (PKR) isozyme. The investigational medicinal product (IMP) is being developed for the treatment of inherited haemoglobinopathies, such as Sickle cell disease (SCD) and thalassemia.</div>\n <div>\n  </div>\n</div>\n<p>\n  </p>\n
      • short_titleFLORAL
      • protocol_noECCT/25/01/01
      • version_no1
      • date_of_protocol03-05-2024
      • study_drugEtavopivat
      • disease_conditionsickle cell disease
      • 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_nameetavopivat
      • 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_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_applicantSylvia Macharia
      • declaration_date108-01-2025
      • declaration_principal_investigatorBenhards Ogutu
      • declaration_date204-12-2024
      • placebo_presentNo
      • study_objectives<p>\n To investigate long-term safety of etavopivat in adults, adolescents and children with SCD, SCDTD, TDT or NTDT transferring from other studies with etavopivat</p>\n<p>\n To investigate long-term clinical efficacy measures of etavopivat treatment in adults, adolescents and children with SCD transferring from other studies with etavopivatb</p>\n<p>\n To evaluate the effects of etavopivat on hospitalisations in adults, adolescents and children with SCD transferring from other studies with etavopivatb</p>\n<p>\n To investigate long-term clinical efficacy measures of etavopivat treatment in adults and adolescents with NTDT transferring from other studies with etavopivat</p>\n<p>\n To investigate long-term clinical efficacy measures of etavopivat treatment in adults and adolescents with TDT or SCDTD, transferring from other studies with etavopivat</p>\n
      • principal_inclusion_criteria<p>\n Participants are eligible to be included in the study only if all the following criteria apply:</p>\n<p>\n 1. Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study. United Kingdom: Please see country-specific requirements in Appendix 8 (Section 10.8).</p>\n<p>\n 2. Participant must have ongoing participation in an etavopivat parent study (Table 4-1) for treatment of SCD or thalassaemia and have completed at least a treatment period of the parent study.</p>\n<p>\n  3. Participant must have derived clinical benefit from treatment with etavopivat, as determined by the investigator.</p>\n<p>\n 4. Any participant with dose reduction or temporary discontinuation will need to be rechallenged before transferring.</p>\n<p>\n  5. Participants on hydroxyurea (HU), crizanlizumab or l-glutamine oral powder (Endari®) treatment at the time of consent may be eligible if they:</p>\n<p>\n  a. Have been on a stable dose during participation in the parent study (i.e., no changes to the dose except for changes to weight or age reasons).</p>\n<p>\n b. Have been compliant with the treatment regimen at the discretion of the investigator during participation of the parent study.</p>\n<p>\n  </p>\n<p>\n  </p>\n
      • principal_exclusion_criteria<table border=\"0\" cellpadding=\"0\" cellspacing=\"0\" style=\"width:677px;\" width=\"677\">\n <tbody>\n <tr>\n <td style=\"width:677px;height:242px;\">\n <p>\n  List them here;</p>\n <p>\n  Participants are excluded from the study if any of the following criteria apply:</p>\n <p>\n 1. Previous participation in this study. Participation is defined as signed informed consent.</p>\n <p>\n 2. Female who is pregnant or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method, as defined in Appendix 4 (Section 10.4).</p>\n <p>\n 3. Any disorder, except for conditions associated with SCD or thalassaemia, which in the investigator’s opinion might jeopardise participant’s safety or compliance with the protocol.</p>\n <p>\n 4. Participant withdrew or had permanent treatment discontinuation from an etavopivat clinical study.</p>\n <p>\n 5. Participants on permanent treatment dose reduction or temporary treatment discontinuation.</p>\n <p>\n 6. Use of any of the following within the timeframes prior to the transfer visit as stated:</p>\n <p>\n      a. Use of voxelotor within participation of the parent study or anticipated need for this agent during this study</p>\n <p>\n      b. Use of an experimental selectin antagonist (e.g., monoclonal antibody or small molecule) within the parent study or anticipated need for such agents during this study.</p>\n <p>\n      c. Use of erythropoietin or other haematopoietic growth factor treatment within the parent study or anticipated need for such agents during this study.</p>\n <p>\n     d. Receiving or use of concomitant medications that are strong inducers of cytochrome P450 (CYP) 3A4 within 2 weeks of the transfer visit or anticipated need for such agents during the study.</p>\n <p>\n 7. Current participation in a study that is not a designated parent study, or planned participation in any other clinical trial, for the duration of FLORAL</p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n
      • primary_end_points<p>\n ·       Number of TEAEs, reported for each indication and age group separately.</p>\n<p>\n Number of adverse reactions, reported for each indication and age group separately </p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy1
      • scope_safety1
      • scope_efficacy1
      • 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_confirmatory1
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n The study will be conducted at Ahero Clinical Trials Unit (ACTU), a satellite unit of Centre for Clinical Research of the Kenya Medical Research Institute (KEMRI) and also affiliated to the Center for Research in Therapeutic Sciences (CREATES), Strathmore University. The unit was set up in the year 2008 for the conduct of clinical trials in malaria as the area is within an area of all year transmission of malaria.</p>\n<p>\n The site has a well-equipped consultation office with coaches, emergency tray and drugs including oxygen with the ability to manage appropriately medical emergencies. There is also a pharmacy, well equipped laboratory with the ability to perform routine tests and a spacious archive and data entry rooms.</p>\n<p>\n The site has 2 pediatricians assisted by 4 medical officers and a number of clinical officers, nurses and laboratory technicians to conduct the clinical trials and offer medical care to research participants.</p>\n<p>\n The ACTU is capable of conducting regulated clinical trials to evaluate vaccines, drugs, or diagnostic platforms for a variety of pathogens found in the area and the other emerging infectious diseases such as COVID-19. Recently, the site began conducting epidemiological studies in various fields. The ACTU is located within Ahero County Hospital along Nairobi – Kisumu Road. The research team has a close affiliation with the Kenyan Ministry of Health at the county and national levels and has personnel working in the Ministry of Health facilities within the study area. Trained unit field workers and Ministry of Health Community Health Workers assist with study activities conducted in the field and in satellite facilities </p>\n
      • other_details_explanation<p style=\"margin-left:-.25pt;\">\n The trial is to be conducted in the host country.</p>\n<p>\n  </p>\n
      • other_details_regulatory_notapproved<p style=\"margin-left:-.25pt;\">\n Turkey JA Submitted 11 Jul 2024</p>\n<p style=\"margin-left:-.25pt;\">\n US FDA submitted 26 June 2024</p>\n<p>\n Nigeria National Foods and Drugs Authority submitted 15 October 2024</p>\n
      • other_details_regulatory_approved<p style=\"margin-left:-.25pt;\">\n Health Canada Submitted 16 Jul 2024 received an approval on 12 Aug 2024</p>\n<p style=\"margin-left:-.25pt;\">\n EMA Submitted 31 Jul 2024 received approval on 22 Nov 2024</p>\n<p>\n  </p>\n
      • other_details_regulatory_rejected<p>\n Not Applicable</p>\n
      • other_details_regulatory_halted<p>\n This trial has not been halted by any regulatory authorities.</p>\n
      • estimated_durationup to 260 weeks.
      • design_controlled_randomisedNo
      • design_controlled_openYes
      • design_controlled_single_blindNo
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorNon Randomised
      • 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_states17
      • number_of_sites7
      • multi_country_listCanada, Egypt, France, Germany, Ghana, Greece, India, Italy, Lebanon, Nigeria, Oman, Saudi Arabia, Spain, Turkey, USA, United Kingdom, Kenya
      • data_monitoring_committeeNo
      • total_enrolment_per_siteTotal enrolment in each Kenyan site: (if competitive enrolment, state minimum and maximum number per site.) As this is a rollover trial, we cannot predict the enrollment in each site as the parent trials have competitive enrollment
      • total_participants_worldwide325
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerYes
      • 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_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentYes
      • subjects_specifyConsent of pediatric participants (below 18 years of age) is obtained by means of parents or legally acceptable representatives
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameBernhards
      • investigator1_middle_name
      • investigator1_family_nameOgutu
      • investigator1_qualificationMD
      • investigator1_professional_addressStrathmore University- CREATES Ole Sangale Road, Madaraka Estate, P.O BOX 59857-00200, Nairobi, Kenya
      • investigator1_telephone254733812613/254733966065
      • investigator1_emailogutu6@gmail.com
      • organisations_transferred_Yes
      • number_participants25
      • notification<p>\n Attached above are reponses to second round of screening comments also attached in the checklist section.</p>\n
      • approval_date24-04-2025
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted08-01-2025
      • is_child0
      • unsubmitted1
      • initial_date_submitted08-01-2025
      • 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)
      • modified2025-04-30 16:31:26
      • created2024-11-27 17:42:24
      • total_sites1
      • ecitizen_invoice332522
    • InvestigatorContact(array)
      • 0(array)
        • id1195
        • application_id1492
        • given_nameBernhard
        • middle_name
        • family_nameOgutu
        • qualificationMD
        • professional_addressStrathmore University- CREATES Ole Sangale Road, Madaraka Estate, P.O BOX 59857-00200, Nairobi, Kenya
        • telephone254733812613/254733966065
        • emailogutu6@gmail.com
        • created2024-11-27 17:43:29
        • modified2025-01-30 11:46:31
    • SiteDetail(array)
      • 0(array)
        • id1822
        • application_id1492
        • county_id42
        • site_nameCenter for Research in Therapeutic Sciences (CREATES)
        • physical_addressAhero County Hospital
        • contact_detailsogutu6@gmail.com
        • contact_personDr Benhards Ogutu
        • site_capacity(null)
        • misc(null)
        • created2024-11-27 17:43:29
        • modified2025-01-30 11:46:31
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
      • 1(array)
        • id1824
        • application_id1492
        • county_id47
        • site_nameGertrude’s Children’s Hospital
        • physical_addressGertrude\'s Children\'s Hospital 34 Muthaiga road
        • contact_detailsjgithanga3@gmail.com
        • contact_personProf Jessie Githanga
        • site_capacity(null)
        • misc(null)
        • created2024-12-04 08:43:37
        • modified2025-01-30 11:46:31
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
      • 2(array)
        • id1829
        • application_id1492
        • county_id41
        • site_nameKEMRI Siaya Clinical Research Annex
        • physical_addressSiaya County Referral hospital grounds
        • contact_detailsvduba@gmail.com
        • contact_personProf V Nduba
        • site_capacity(null)
        • misc(null)
        • created2024-12-16 10:17:16
        • modified2025-01-30 11:46:31
        • County(array)
          • id41
          • county_nameSiaya
          • created2012-06-15 10:26:56
          • modified2012-06-15 10:26:56
      • 3(array)
        • id1830
        • application_id1492
        • county_id42
        • site_nameKEMRI/ WRAIR-Africa, Kombewa Clinical Research Center
        • physical_addressPO Box 54-40100, Kisumu , Kenya
        • contact_detailsjanet.oyieko@usamru-k.org or janet.oyieko@gmail.com
        • contact_personDr Janet Oyieko
        • site_capacity(null)
        • misc(null)
        • created2024-12-16 10:17:16
        • modified2025-01-30 11:46:31
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
      • 4(array)
        • id1831
        • application_id1492
        • county_id35
        • site_nameKEMRI WALTER REED KERICHO
        • physical_addressP.O. BOX 1357- 20200
        • contact_detailsisaac.tsikhutsu@usamru-k.org or itsikhutsu@yahoo.com
        • contact_personDr Isaac Tsikhutsu
        • site_capacity(null)
        • misc(null)
        • created2024-12-16 10:17:16
        • modified2025-01-30 11:46:31
        • County(array)
          • id35
          • county_nameKericho
          • created2012-06-15 10:26:16
          • modified2012-06-15 10:26:16
      • 5(array)
        • id1832
        • application_id1492
        • county_id42
        • site_nameKEMRI Kondele Children\'s Hospital
        • physical_addressCentre for Clinical Research Within Jaramogi Oginga Odinga Hospital
        • contact_detailsogutu6@gmail.com
        • contact_personDr Benhards Ogutu
        • site_capacity(null)
        • misc(null)
        • created2024-12-16 10:17:16
        • modified2025-01-30 11:46:31
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
      • 6(array)
        • id1833
        • application_id1492
        • county_id42
        • site_nameKEMRI/ WRAIR-Africa, Kombewa Clinical Research Center
        • physical_addressPO Box 54-40100, Kisumu , Kenya
        • contact_detailswalter.otieno@usamru-k.org
        • contact_personDr Walter Otieno
        • site_capacity(null)
        • misc(null)
        • created2024-12-16 10:17:16
        • modified2025-01-30 11:46:31
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
    • Sponsor(array)
      • 0(array)
        • id793
        • application_id1492
        • sponsorNovo Nordisk A/S
        • sponsor_typeOthers
        • contact_personIsabella Andreotti
        • addressNovo Allé, 2880 Bagsvaerd, Denmark
        • telephone_number+45-34481755
        • fax_number
        • cell_number+45-34481755
        • email_address7822-HQ-TM@novonordisk.com
        • created2024-11-27 17:43:29
        • modified2025-01-30 11:46:31
• page_options(array)
  • 55
  • 1010
• redir
• $request->data(array)
  • Application(array)
    • approved1
• $this->validationErrors(array)
  • Permission(empty)
  • Aro(empty)
  • Aco(empty)
  • Application(empty)
  • User(empty)
  • TrialStatus(empty)
  • InvestigatorContact(empty)
  • Sponsor(empty)
  • SiteDetail(empty)
  • County(empty)
• Loaded Helpers(array)
  • 0Html
  • 1Form
  • 2Session
  • 3Text
  • 4Number
  • 5SimpleGraph
  • 6Paginator
  • 7DebugTimer
  • 8Toolbar
  • 9HtmlToolbar

App Constants

CakePHP Constants

PHP Environment

Included Files

Include Paths

• 0/var/www/html/ctr/app/Plugin/Media/Lib/mm/src
• 1/var/www/html/ctr/lib
• 3/usr/share/php
• 4-> /var/www/html/ctr/lib/Cake/

Included Files

• core(array)
  • Behavior(array)
    • 0CORE/Model/Behavior/TreeBehavior.php
    • 1CORE/Model/Behavior/ContainableBehavior.php
    • 2CORE/Model/Behavior/AclBehavior.php
  • Cache(array)
    • 0CORE/Cache/Cache.php
    • 1CORE/Cache/Engine/FileEngine.php
    • 2CORE/Cache/CacheEngine.php
  • Component(array)
    • 0CORE/Controller/Component/AclComponent.php
    • 1CORE/Controller/Component/Acl/DbAcl.php
    • 2CORE/Controller/Component/Acl/AclInterface.php
    • 3CORE/Controller/Component/AuthComponent.php
    • 4CORE/Controller/Component/RequestHandlerComponent.php
    • 5CORE/Controller/Component/SessionComponent.php
    • 6CORE/Controller/Component/PaginatorComponent.php
  • Config(array)
    • 0CORE/Config/routes.php
    • 1CORE/Config/config.php
  • Controller(array)
    • 0CORE/Controller/Controller.php
    • 1CORE/Controller/ComponentCollection.php
    • 2CORE/Controller/Component.php
  • Datasource(array)
    • 0CORE/Model/Datasource/CakeSession.php
    • 1CORE/Model/Datasource/Database/Mysql.php
    • 2CORE/Model/Datasource/DboSource.php
    • 3CORE/Model/Datasource/DataSource.php
  • Error(array)
    • 0CORE/Error/exceptions.php
    • 1CORE/Error/ErrorHandler.php
  • I18n(array)
    • 0CORE/I18n/I18n.php
    • 1CORE/I18n/L10n.php
  • Log(array)
    • 0CORE/Log/CakeLog.php
    • 1CORE/Log/LogEngineCollection.php
    • 2CORE/Log/Engine/FileLog.php
    • 3CORE/Log/Engine/BaseLog.php
    • 4CORE/Log/CakeLogInterface.php
  • Model(array)
    • 0CORE/Model/ConnectionManager.php
    • 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