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      • id1389
      • user_id567
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      • abstract_of_study<p>\n <strong>Background</strong></p>\n<p>\n Three drug regimens for the treatment of HIV are widely used and successful in achieving viral suppression. However, they are associated with various adverse events including renal and bone disease, anemia, mitochondrial toxicity, and possible association with increased cardiovascular events. Data from the ongoing BFTAF Elderly Switch Study has demonstrated high rates of renal insufficiency and osteoporosis in people living with HIV aged 60 years or more, hence the need for safe treatment options. Two drug regimens (2DR) have demonstrated non-inferiority to three drug regimens in patients who are treatment naïve as well as in those who are virally suppressed on a first-line regimen and potentially have lower toxicity, fewer adverse drug events and a lower drug burden.</p>\n<p>\n <strong>Objectives</strong></p>\n<p>\n To assess the efficacy and safety of switch to dolutegravir and lamivudine (DTG/3TC) single tablet regimen from bictegravir, emtricitabine and tenofovir alafenamide (B/F/TAF) in persons living with HIV aged 60 years old or more.</p>\n<p>\n <strong>Methods</strong></p>\n<p>\n This is a phase 3b, multi-center, open-label, single arm clinical trial over 96 weeks. The study will take place at two sites in Kenya: Kenyatta National Hospital (KNH) and Jaramogi Oginga Odinga Teaching and Referral Hospital (JOOTRH). Study visits will take place at screening, baseline, and weeks 4, 12, 24, 36, 48, 60, 72, 84, and 96 (with a 6-week extension as required for confirming HIV-1 RNA levels). A target of 240 participants from the ongoing BFTAF Elderly Switch Study will be enrolled. Eligible participants will be switched from B/F/TAF to DTG/3TC at enrollment and followed up for 96 weeks. The primary endpoint will be the proportion of participants with plasma HIV-1 RNA ≥ 50 copies/mL (Snapshot algorithm) at Week 48. Analysis of the primary endpoint will be performed for the ITT-E population using the FDA snapshot method.</p>\n<p>\n Data Management: The collection and processing of personal data from s enrolled in this study will be limited to those data that are necessary to investigate the primary and secondary objectives. These data will be collected using electronic Case Report Forms and processed with adequate precautions to ensure confidentiality and compliance with data privacy and protection laws and regulations</p>\n<p>\n <strong>Study Utility</strong></p>\n<p>\n The Kenyan national HIV program currently recommends tenofovir disoproxil fumarate (TDF) as the preferred nucleoside reverse transcriptase inhibitor (NRTI). TDF is associated with both renal and bone toxicity and in the absence of safer tenofovir pro-drugs such as tenofovir alafenamide (TAF), it is important to consider regimens that exclude the toxic NTRIs such as the two-drug regimen of lamivudine and dolutegravir, especially in populations that are at risk of multiple comorbidities. This will provide useful data to inform policy and programming.</p>\n
      • study_title<p>\n Efficacy, Safety and Tolerability of Switching to DTG/3TC Single Tablet Regimen from B/F/TAF in Older Persons Living with HIV in Kenya</p>\n
      • laymans_summary<p align=\"center\" style=\"margin: 0cm 0cm 7.5pt; font-size: 12pt; font-family: "Times New Roman", serif; color: rgb(0, 0, 0); text-align: center; background-image: initial; background-position: initial; background-size: initial; background-repeat: initial; background-attachment: initial; background-origin: initial; background-clip: initial;\">\n <strong><span style=\"font-size: 10.5pt; font-family: Arial, sans-serif; color: rgb(51, 51, 51);\">Efficacy, Safety and Tolerability of Switching to DTG/3TC Single Tablet Regimen from B/F/TAF in Older Persons Living with HIV in Kenya</span></strong><span style=\"font-size: 9.5pt; font-family: "Trebuchet MS", sans-serif; color: rgb(51, 51, 51);\"><o:p></o:p></span></p>\n<p style=\"margin: 0cm 0cm 7.5pt; font-size: 12pt; font-family: "Times New Roman", serif; color: rgb(0, 0, 0); background-image: initial; background-position: initial; background-size: initial; background-repeat: initial; background-attachment: initial; background-origin: initial; background-clip: initial;\">\n <span style=\"font-size: 9.5pt; font-family: "Trebuchet MS", sans-serif; color: rgb(51, 51, 51);\"> <o:p></o:p></span></p>\n<p style=\"margin: 0cm 0cm 7.5pt; font-size: 12pt; font-family: "Times New Roman", serif; color: rgb(0, 0, 0); text-align: justify; background-image: initial; background-position: initial; background-size: initial; background-repeat: initial; background-attachment: initial; background-origin: initial; background-clip: initial;\">\n <strong><span style=\"font-size: 10.5pt; font-family: Arial, sans-serif; color: rgb(51, 51, 51);\">Background: </span></strong><span style=\"font-size: 10.5pt; font-family: Arial, sans-serif; color: rgb(51, 51, 51);\">The standard treatment for HIV comprises three or four drugs in order to achieve viral suppression. However, the use of some of these drugs may affect the kidneys, bone and other body systems. For example, an ongoing study in Kenya has demonstrated high rates of kidney and bone disease in older persons living with HIV aged 60 years old or more.<o:p></o:p></span></p>\n<p style=\"margin: 0cm 0cm 7.5pt; font-size: 12pt; font-family: "Times New Roman", serif; color: rgb(0, 0, 0); text-align: justify; background-image: initial; background-position: initial; background-size: initial; background-repeat: initial; background-attachment: initial; background-origin: initial; background-clip: initial;\">\n <span style=\"font-size: 10.5pt; font-family: Arial, sans-serif; color: rgb(51, 51, 51);\">Recent studies have shown that two-drug regimens such as a combination of dolutegravir (DTG) and lamivudine (3TC) may achieve the same rates of viral suppression after switching from other treatment regimens containing three drugs. The use of a two-drug regimen means that there will be a lower drug burden that may have less harmful effects including improving bone health and kidney function.</span><span style=\"font-size: 9.5pt; font-family: "Trebuchet MS", sans-serif; color: rgb(51, 51, 51);\"> </span><span style=\"font-size: 10.5pt; font-family: Arial, sans-serif; color: rgb(51, 51, 51);\"><o:p></o:p></span></p>\n<p style=\"margin-right: 0cm; margin-left: 0cm; font-size: 12pt; font-family: "Times New Roman", serif; color: rgb(0, 0, 0); text-align: justify; background-image: initial; background-position: initial; background-size: initial; background-repeat: initial; background-attachment: initial; background-origin: initial; background-clip: initial;\">\n <strong><span style=\"font-size: 10.5pt; font-family: Arial, sans-serif; color: rgb(51, 51, 51);\">Objective: </span></strong><span style=\"font-size: 10.5pt; font-family: Arial, sans-serif; color: rgb(51, 51, 51);\">The purpose of the study is to determine whether older persons living with HIV (60 years old or above) who are currently virally suppressed on their first line antiretroviral regimen containing bictegravir, emtricitabine and tenofovir alafenamide (B/F/TAF) can safely be switched to a two-drug regimen of dolutegravir (DTG) and lamivudine (3TC).<o:p></o:p></span></p>\n<p style=\"margin: 0cm 0cm 7.5pt; font-size: 12pt; font-family: "Times New Roman", serif; color: rgb(0, 0, 0); text-align: justify; background-image: initial; background-position: initial; background-size: initial; background-repeat: initial; background-attachment: initial; background-origin: initial; background-clip: initial;\">\n <strong><span style=\"font-size: 10.5pt; font-family: Arial, sans-serif; color: rgb(51, 51, 51);\">Participants and Methods: </span></strong><span style=\"font-size: 10.5pt; font-family: Arial, sans-serif; color: rgb(51, 51, 51);\">We will enroll 240 participants in two sites in Kenya: Kenyatta National Hospital in Nairobi and Jaramogi Oginga Odinga Teaching and Referral Hospital in Kisumu. After providing written informed consent, participants will be evaluated for eligibility. Those who are enrlled will have their treatment regimen changed to a combined pill containing DTG and 3TC taken once daily for the duration of the study. Thereafter, each person will be followed up for 96 weeks (about two years). All participants will have scheduled visits at weeks 4, 12, 24, 36, 48, 60, 72, 84 and 96. During follow-up, the amount of HIV virus in blood will be checked alongside other laboratory and radiological tests assessing for safety.<o:p></o:p></span></p>\n
      • short_titleB/F/TAF to DTG/3TC Switch Stud
      • protocol_noECCT/24/04/01
      • version_no1.2
      • date_of_protocol07-03-2024
      • study_drugDolutegravir (DTG) and Lamivudine (3TC)
      • disease_conditionHIV
      • 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_nameAvridela
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressloisea@uonbi.ac.ke
      • 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_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 Loice Achieng Ombajo
      • declaration_date103-04-2024
      • declaration_principal_investigatorDr Loice Achieng Ombajo
      • declaration_date203-04-2024
      • placebo_presentNo
      • study_objectives<p border:=\"\" class=\"BodyBA\" color:=\"\" new=\"\" style=\"margin: 0cm; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <span class=\"NoneA\"><b><span lang=\"EN-US\" style=\"font-family: Calibri, sans-serif;\">Primary Objective</span></b></span><b><span lang=\"EN-US\" style=\"font-family: Calibri, sans-serif;\"><o:p></o:p></span></b></p>\n<p border:=\"\" class=\"BodyBA\" color:=\"\" new=\"\" style=\"margin: 0cm; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <span class=\"NoneA\"><span lang=\"EN-US\" style=\"font-family: Calibri, sans-serif;\">To evaluate the maintenance of virologic suppression of DTG/3TC at Week 48 post-switch from BIC/FTC/TAF</span></span><span lang=\"EN-US\" style=\"font-family: Calibri, sans-serif;\"><o:p></o:p></span></p>\n<p border:=\"\" class=\"BodyBA\" color:=\"\" new=\"\" style=\"margin: 0cm; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <span class=\"None\"><span lang=\"EN-US\" style=\"font-family: Calibri, sans-serif;\"> </span></span></p>\n<p border:=\"\" class=\"BodyBA\" color:=\"\" new=\"\" style=\"margin: 0cm; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <span class=\"NoneA\"><b><span lang=\"EN-US\" style=\"font-family: Calibri, sans-serif;\">Secondary Objectives</span></b></span><b><span lang=\"EN-US\" style=\"font-family: Calibri, sans-serif;\"><o:p></o:p></span></b></p>\n<ul>\n <li border:=\"\" class=\"BodyBA\" color:=\"\" new=\"\" style=\"margin: 0cm; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <span class=\"NoneA\"><span lang=\"EN-US\" style=\"font-family: Calibri, sans-serif;\">To evaluate the antiviral activity, immunologic effects, and incidence of disease progression (HIV-associated conditions, AIDS and death) of DTG/3TC over time</span></span><span lang=\"EN-US\" style=\"font-family: Calibri, sans-serif;\"><o:p></o:p></span></li>\n <li border:=\"\" class=\"BodyBA\" color:=\"\" new=\"\" style=\"margin: 0cm; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <span class=\"NoneA\"><span lang=\"EN-US\" style=\"font-family: Calibri, sans-serif;\">To assess viral resistance in participants experiencing protocol-defined virologic failure over time</span></span><span lang=\"EN-US\" style=\"font-family: Calibri, sans-serif;\"><o:p></o:p></span></li>\n <li border:=\"\" class=\"BodyBA\" color:=\"\" new=\"\" style=\"margin: 0cm; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <span class=\"NoneA\"><span lang=\"EN-US\" style=\"font-family: Calibri, sans-serif;\">To evaluate the safety and tolerability of DTG/3TC over time</span></span><span lang=\"EN-US\" style=\"font-family: Calibri, sans-serif;\"><o:p></o:p></span></li>\n <li border:=\"\" class=\"BodyBA\" color:=\"\" new=\"\" style=\"margin: 0cm; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <span class=\"NoneA\"><span lang=\"EN-US\" style=\"font-family: Calibri, sans-serif;\">To evaluate the efficacy and immunologic response of DTG/3TC by participant characteristics subgroups (e.g., demographic factors, Baseline CD4, CD4 nadir) and pre-specified target population (≥65 years old, CV risk, women, co-medication) over time</span></span><span lang=\"EN-US\" style=\"font-family: Calibri, sans-serif;\"><o:p></o:p></span></li>\n <li border:=\"\" class=\"BodyBA\" color:=\"\" new=\"\" style=\"margin: 0cm; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <span class=\"NoneA\"><span lang=\"EN-US\" style=\"font-family: Calibri, sans-serif;\">To evaluate renal (in urine and blood) biomarkers over time</span></span><span lang=\"EN-US\" style=\"font-family: Calibri, sans-serif;\"><o:p></o:p></span></li>\n <li border:=\"\" class=\"BodyBA\" color:=\"\" new=\"\" style=\"margin: 0cm; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <span class=\"NoneA\"><span lang=\"EN-US\" style=\"font-family: Calibri, sans-serif;\">To evaluate cardiovascular risk over time</span></span><span lang=\"EN-US\" style=\"font-family: Calibri, sans-serif;\"><o:p></o:p></span></li>\n <li border:=\"\" class=\"BodyBA\" color:=\"\" new=\"\" style=\"margin: 0cm; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <span class=\"NoneA\"><span lang=\"EN-US\" style=\"font-family: Calibri, sans-serif;\">To evaluate fasting lipids over time</span></span><span lang=\"EN-US\" style=\"font-family: Calibri, sans-serif;\"><o:p></o:p></span></li>\n <li border:=\"\" class=\"BodyBA\" color:=\"\" new=\"\" style=\"margin: 0cm; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <span class=\"NoneA\"><span lang=\"EN-US\" style=\"font-family: Calibri, sans-serif;\">To evaluate weight and body morphology evolution over time</span></span><span lang=\"EN-US\" style=\"font-family: Calibri, sans-serif;\"><o:p></o:p></span></li>\n <li border:=\"\" class=\"BodyBA\" color:=\"\" new=\"\" style=\"margin: 0cm; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <span class=\"NoneA\"><span lang=\"EN-US\" style=\"font-family: Calibri, sans-serif;\">To assess health-related quality of life</span></span><span lang=\"EN-US\" style=\"font-family: Calibri, sans-serif;\"><o:p></o:p></span></li>\n <li border:=\"\" class=\"BodyBA\" color:=\"\" new=\"\" style=\"margin: 0cm; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <span class=\"NoneA\"><span lang=\"EN-US\" style=\"font-family: Calibri, sans-serif;\">To assess patient treatment satisfaction</span></span><span lang=\"EN-US\" style=\"font-family: Calibri, sans-serif;\"><o:p></o:p></span></li>\n</ul>\n
      • principal_inclusion_criteria<ol>\n <li>\n <p>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Able and willing to understand and comply with the protocol requirements, instructions and restrictions</span></span></p>\n </li>\n <li>\n <p>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Able and willing to give informed consent</span></span></p>\n </li>\n <li>\n <p>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Have been randomised to the B/F/TAF arm and completed the B/F/TAF-elderly study.  Participant should be on B/F/TAF until day 1 of entry into the current study</span></span></p>\n </li>\n <li>\n <p>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">HIV-1 RNA viral load < 50 copies/ml at screening (within 28 days prior to enrollment)</span></span></p>\n </li>\n</ol>\n
      • principal_exclusion_criteria<ol>\n <li>\n Confirmed treatment failure as defined by two consecutive HIV-1 RNA viral loads ≥ 50 copies/ml separated by at least 2 weeks, after at least 6 months on ART or after a documented HIV-1 RNA viral load < 50 copies/ml</li>\n <li>\n Using any protocol-defined prohibited medicine where the participant is unwilling or unable to switch to an alternative (see Section 5.2. under Prohibited medications and non-drug therapies)</li>\n <li>\n Evidence of hepatitis B virus (HBV) infection based on the results of testing at screening for hepatitis B surface antigen (HBsAg), hepatitis B core antibody (anti-HBc), hepatitis B surface antibody (anti-HBs) and HBV DNA as follows:\n <ul>\n <li>\n a) Participants positive for HBsAg are excluded;</li>\n <li>\n b) Participants negative for anti-HBs but positive for anti-HBc (negative HBsAg status), whether negative or positive for HBV DNA, are excluded;</li>\n <li>\n c) Participants positive for anti-HBc (negative HBsAg status) and positive for anti-HBs (past and/or current evidence) are immune to HBV and are not excluded.</li>\n </ul>\n </li>\n <li>\n Has AST and/or ALT at least 5-times greater than the upper limit of normal</li>\n <li>\n Severe hepatic impairment (Class C) as determined by Child-Pugh classification</li>\n <li>\n Has a CrCl below 30 ml/min (as estimated using the Cockcroft-Gault estimate for glomerular filtration rate)</li>\n <li>\n Documented opportunistic infection within 4 weeks prior to the study enrolment</li>\n <li>\n Any condition (including illicit drug use or alcohol abuse) or laboratory results which, in the investigator’s opinion, interfere with assessments or completion of the study</li>\n <li>\n Untreated syphilis infection (positive rapid plasma reagin [RPR] at Screening without clear documentation of treatment). Participants who are at least 7 days post completed treatment are eligible.</li>\n <li>\n History or presence of allergy or intolerance to the study treatment or their components or drugs of their class or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation.</li>\n <li>\n Ongoing malignancy other than cutaneous Kaposi’s sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical, anal or penile intraepithelial neoplasia.</li>\n <li>\n Participants who in the investigator’s judgment, poses a significant suicidality risk. Participant’s history of suicidal behavior and/or suicidal ideation should be considered when evaluating for suicide risk</li>\n <li>\n Any evidence of any major 3TC resistance associated mutations (M184V/I and/or K65R and/or MDR) or presence of any major INSTI resistance associated mutation</li>\n</ol>\n<div>\n  </div>\n
      • primary_end_points<p>\n Participants with plasma HIV-1 RNA ≥ 50 copies/mL (snapshot algorithm) at week 48</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • 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_controlledNo
      • site_capacity(null)
      • staff_numbers<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 7.5pt; font-size: 12pt; font-family: \" times=\"\">\n <strong><span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">CAPABILITY STATEMENT FOR KNH COMPREHENSIVE CARE CENTRE TO CONDUCT CLINICAL RESEARCH</span></strong><span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\"><o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 7.5pt; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">Kenyatta National Hospital Comprehensive Care Centre (CCC) was established in December 2002 as the pioneer care and treatment centre for HIV/AIDS. The Centre was established with the support of the USAID/FHI/KNH cooperative agreement with the main objective of mitigating the effects of HIV/AIDS nationally by participating in the national HIV/AIDS response. Since 2005, services and expansion of the Centre have been supported by Center for Disease Prevention and Control (CDC) through the University of Nairobi, AIDS Care and Treatment Services (ACTS), Partnership for Advanced Care and Treatment – Centre of Excellence (PACT - CoE) and Centers’ of Excellence - HIV Medicine (CoEHM) Programs, and the Center for International Health, Education, and Biosecurity (CIHEB) - Kenya. It has evolved over time to be a centre of excellence for ambulatory HIV medicine in the country dealing with both complicated referral patients and stable patients.  <o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 7.5pt; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">The CCC offers a one-stop-shop approach in the management of HIV/AIDS. In order to achieve this goal, a multidisciplinary team with different specializations in HIV/AIDS management runs the centre. This team consists of Consultants, Medical Specialists, Medical Officers, Registered Clinical Officers, Pharmacists and Pharmaceutical Technologists, Counsellors, Laboratory Staff, Nursing Officers, Nutritionists and social workers among others.<o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 7.5pt; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\"> The services offered at the Comprehensive Care Centre include the following:<o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 0cm 58.75pt; font-size: 12pt; font-family: \" text-align:=\"\" text-indent:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">1.<span new=\"\" style=\"font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-alternates: normal; font-kerning: auto; font-optical-sizing: auto; font-feature-settings: normal; font-variation-settings: normal; font-variant-position: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: \" times=\"\">       </span></span><span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">Diagnosis and Treatment of opportunistic infections and other HIV/AIDS related co-morbidities<o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 0cm 58.75pt; font-size: 12pt; font-family: \" text-align:=\"\" text-indent:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">2.<span new=\"\" style=\"font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-alternates: normal; font-kerning: auto; font-optical-sizing: auto; font-feature-settings: normal; font-variation-settings: normal; font-variant-position: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: \" times=\"\">       </span></span><span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">Anti-Retroviral Therapy both 1^st line; 2^nd line and 3^rd line regimens as per the WHO guidelines<o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 0cm 58.75pt; font-size: 12pt; font-family: \" text-align:=\"\" text-indent:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">3.<span new=\"\" style=\"font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-alternates: normal; font-kerning: auto; font-optical-sizing: auto; font-feature-settings: normal; font-variation-settings: normal; font-variant-position: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: \" times=\"\">       </span></span><span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">Laboratory monitoring and evaluation of the patients - The centre has an ISO 15189:2012 standard accredited laboratory which has equipment that can do the following analytical procedures:<o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 0cm 72pt; font-size: 12pt; font-family: \" text-align:=\"\" text-indent:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">a.<span new=\"\" style=\"font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-alternates: normal; font-kerning: auto; font-optical-sizing: auto; font-feature-settings: normal; font-variation-settings: normal; font-variant-position: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: \" times=\"\">     </span></span><span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">Flow Cytometry <o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 0cm 72pt; font-size: 12pt; font-family: \" text-align:=\"\" text-indent:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">b.<span new=\"\" style=\"font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-alternates: normal; font-kerning: auto; font-optical-sizing: auto; font-feature-settings: normal; font-variation-settings: normal; font-variant-position: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: \" times=\"\">     </span></span><span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">Hematology <o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 0cm 72pt; font-size: 12pt; font-family: \" text-align:=\"\" text-indent:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">c.<span new=\"\" style=\"font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-alternates: normal; font-kerning: auto; font-optical-sizing: auto; font-feature-settings: normal; font-variation-settings: normal; font-variant-position: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: \" times=\"\">      </span></span><span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">Chemistry <o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 0cm 72pt; font-size: 12pt; font-family: \" text-align:=\"\" text-indent:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">d.<span new=\"\" style=\"font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-alternates: normal; font-kerning: auto; font-optical-sizing: auto; font-feature-settings: normal; font-variation-settings: normal; font-variant-position: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: \" times=\"\">     </span></span><span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">TB Diagnosis <o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 0cm 72pt; font-size: 12pt; font-family: \" text-align:=\"\" text-indent:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">e.<span new=\"\" style=\"font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-alternates: normal; font-kerning: auto; font-optical-sizing: auto; font-feature-settings: normal; font-variation-settings: normal; font-variant-position: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: \" times=\"\">     </span></span><span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">HIV EID <o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 0cm 72pt; font-size: 12pt; font-family: \" text-align:=\"\" text-indent:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">f.<span new=\"\" style=\"font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-alternates: normal; font-kerning: auto; font-optical-sizing: auto; font-feature-settings: normal; font-variation-settings: normal; font-variant-position: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: \" times=\"\">      </span></span><span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">HIV Viral Load <o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 0cm 58.75pt; font-size: 12pt; font-family: \" text-align:=\"\" text-indent:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">4.<span new=\"\" style=\"font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-alternates: normal; font-kerning: auto; font-optical-sizing: auto; font-feature-settings: normal; font-variation-settings: normal; font-variant-position: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: \" times=\"\">       </span></span><span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">Research: Since its inception the centre has actively been involved in research which has informed HIV/AIDS national policy. Some of the research conducted in the facility by both the University of Nairobi and Kenyatta National Hospital in collaboration with international partners include: <o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 0cm 72pt; font-size: 12pt; font-family: \" text-align:=\"\" text-indent:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">a.<span new=\"\" style=\"font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-alternates: normal; font-kerning: auto; font-optical-sizing: auto; font-feature-settings: normal; font-variation-settings: normal; font-variant-position: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: \" times=\"\">     </span></span><span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">A clinical trial with almost 400 participants at the site to determine the efficacy of a switch to DTG-based ART from the standard PI/r-based ART for PLHIV on second-line ART<o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 0cm 72pt; font-size: 12pt; font-family: \" text-align:=\"\" text-indent:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">b.<span new=\"\" style=\"font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-alternates: normal; font-kerning: auto; font-optical-sizing: auto; font-feature-settings: normal; font-variation-settings: normal; font-variant-position: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: \" times=\"\">     </span></span><span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">A clinical trial with over 300 participants evaluating the effectiveness of switching older PLHIV on first-line ART to bictegravir, emtricitabine and tenofovir alafenamide (B/F/TAF)<o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 0cm 72pt; font-size: 12pt; font-family: \" text-align:=\"\" text-indent:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">c.<span new=\"\" style=\"font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-alternates: normal; font-kerning: auto; font-optical-sizing: auto; font-feature-settings: normal; font-variation-settings: normal; font-variant-position: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: \" times=\"\">      </span></span><span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">Effectiveness of Non-nucleoside Reverse-Transcriptase Inhibitor-Based Antiretroviral Therapy in Women Previously Exposed to a Single Intrapartum Dose of Nevirapine:  A Multi-country, Prospective Cohort Study<o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 0cm 72pt; font-size: 12pt; font-family: \" text-align:=\"\" text-indent:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">d.<span new=\"\" style=\"font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-alternates: normal; font-kerning: auto; font-optical-sizing: auto; font-feature-settings: normal; font-variation-settings: normal; font-variant-position: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: \" times=\"\">     </span></span><span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">Optimizing Pediatric HAART Study<o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 0cm 72pt; font-size: 12pt; font-family: \" text-align:=\"\" text-indent:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">e.<span new=\"\" style=\"font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-alternates: normal; font-kerning: auto; font-optical-sizing: auto; font-feature-settings: normal; font-variation-settings: normal; font-variant-position: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: \" times=\"\">     </span></span><span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">Evaluation of the Kenya ARV scale-up program:  Surveillance for emergence of antiretroviral resistant genotypes among treatment experienced patients<o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 0cm 72pt; font-size: 12pt; font-family: \" text-align:=\"\" text-indent:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">f.<span new=\"\" style=\"font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-alternates: normal; font-kerning: auto; font-optical-sizing: auto; font-feature-settings: normal; font-variation-settings: normal; font-variant-position: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: \" times=\"\">      </span></span><span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">Treatment outcomes of HIV infected adolescents attending a National Referral Hospital in Kenya:<o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 0cm 72pt; font-size: 12pt; font-family: \" text-align:=\"\" text-indent:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">g.<span new=\"\" style=\"font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-alternates: normal; font-kerning: auto; font-optical-sizing: auto; font-feature-settings: normal; font-variation-settings: normal; font-variant-position: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: \" times=\"\">     </span></span><span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">Trends, treatment outcomes and determinants of attrition among adult patients in care in a large tertiary HIV clinic in Nairobi Kenya<o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 0cm 72pt; font-size: 12pt; font-family: \" text-align:=\"\" text-indent:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">h.<span new=\"\" style=\"font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-alternates: normal; font-kerning: auto; font-optical-sizing: auto; font-feature-settings: normal; font-variation-settings: normal; font-variant-position: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: \" times=\"\">     </span></span><span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">Predicted HIV-1 co receptor usage among Kenya patients shows a high tendency for subtype d to be cxcr4 tropic<o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 0cm 58.75pt; font-size: 12pt; font-family: \" text-align:=\"\" text-indent:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">5.<span new=\"\" style=\"font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-alternates: normal; font-kerning: auto; font-optical-sizing: auto; font-feature-settings: normal; font-variation-settings: normal; font-variant-position: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: \" times=\"\">       </span></span><span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">Training of undergraduate and postgraduate students in the departments of Clinical Medicine and Therapeutics and Pediatrics and Child Health at the University of Nairobi<o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 0cm 58.75pt; font-size: 12pt; font-family: \" text-align:=\"\" text-indent:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">6.<span new=\"\" style=\"font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-alternates: normal; font-kerning: auto; font-optical-sizing: auto; font-feature-settings: normal; font-variation-settings: normal; font-variant-position: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: \" times=\"\">       </span></span><span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">Adherence Counseling<o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 0cm 58.75pt; font-size: 12pt; font-family: \" text-align:=\"\" text-indent:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">7.<span new=\"\" style=\"font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-alternates: normal; font-kerning: auto; font-optical-sizing: auto; font-feature-settings: normal; font-variation-settings: normal; font-variant-position: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: \" times=\"\">       </span></span><span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">Nutritional Counseling<o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 0cm 58.75pt; font-size: 12pt; font-family: \" text-align:=\"\" text-indent:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">8.<span new=\"\" style=\"font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-alternates: normal; font-kerning: auto; font-optical-sizing: auto; font-feature-settings: normal; font-variation-settings: normal; font-variant-position: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: \" times=\"\">       </span></span><span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">Social Work Support<o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 0cm 58.75pt; font-size: 12pt; font-family: \" text-align:=\"\" text-indent:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">9.<span new=\"\" style=\"font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-alternates: normal; font-kerning: auto; font-optical-sizing: auto; font-feature-settings: normal; font-variation-settings: normal; font-variant-position: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: \" times=\"\">       </span></span><span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">Physiotherapy services<o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 0cm 58.75pt; font-size: 12pt; font-family: \" text-align:=\"\" text-indent:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">10.<span new=\"\" style=\"font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-alternates: normal; font-kerning: auto; font-optical-sizing: auto; font-feature-settings: normal; font-variation-settings: normal; font-variant-position: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: \" times=\"\">    </span></span><span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">Supportive Counseling<o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 7.5pt; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\"> <o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 7.5pt; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">The CCC currently serves an average of 150-200 patients per day. Currently, adult patients on ART are 9,400 with 8,150 on first-line regimens and 1,230 on second-line regimens and 20 patients on third-line regimens. There are 4 co-investigators in the B/F/TAF to 2DR Switch Study who are based at the site and 2 site-based study staff (study nurse/counsellor and study clinical officer) have been engaged and are currently working at the CCC. The site currently has 138 PWH aged 60 years or older on B/F/TAF.<o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 7.5pt; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\"> </span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 7.5pt; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <strong><span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">CAPABILITY STATEMENT FOR JOOTRH TO CONDUCT CLINICAL RESEARCH</span></strong><span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\"><o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 7.5pt; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">Jaramogi Oginga Odinga Teaching & Referral Hospital (JOOTRH), formerly known as New Nyanza Provincial General Hospital or Russia was built in 1965 by the Russian Government (then Soviet Union) through the Government of Kenya. <o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 7.5pt; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">The hospital has been named Jaramogi Oginga Odinga in honour of one of the founding fathers of this Nation, Jaramogi Oginga Odinga who played a pivotal role in convincing the Russian Government to fund and build the facility. Henceforth, the hospital will be known as Jaramogi Oginga Odinga Teaching & Referral Hospital (JOOTRH). <o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 7.5pt; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">JOOTRH has been in operation since 1969. It is located in Kisumu city on acreage of 22.6 hectares along Kisumu - Kakamega highway. It is the main referral centre to 10 counties in western Kenya and Rift Valley with a population of more than 7 million people. It has a bed capacity of 530. <o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 7.5pt; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">The main mandate of JOOTRH is to provide curative, preventive, promotive and rehabilitative health services. <o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 7.5pt; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">It provides specialized clinical services in the areas of renal medicine, critical care, oncology, orthopaedic surgery, paediatric surgery and specialized diagnostic services—both radiological and laboratory services. It serves as a centre for research activities, medical training for midlevel health workers and medical students for Maseno University and Uzima university. <o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 7.5pt; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">The hospital has a total of 640 staff consisting of 486 regular staff, 154 donor-supported staff (for HIV care services) as on 1st June 2019.<o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 7.5pt; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">JOOTRH Patient Support Centre (PSC) was started in the year 2002 and has ever enrolled approximately 28,000 clients. Current active on care is 6,842 by the end of June 2019. Total number of clients on first-line are 6,203, on second-line are 600, and 11 clients are on third-line. <o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 7.5pt; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">Out of the 154 staff employed by the CDC-funded implementing partner at the site, 39 are stationed at the PSC and 6 are MOH staff. There is 1 medical officer, 1 pharmacist, 8 nurses, 7 clinical officers, 3 pharmaceutical technologists, 2 social workers, 4 adherence councilors, 8 peer educators, 3 health records information officers, 5 data clerks, 1 nutritionist and 1 laboratory technician. There are 3 co-investigators in the IMPALA Study who are based at the site and 2 site-based study staff (study nurse/counsellor and study clinical officer) have been engaged and are currently working at the PSC.<o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 7.5pt; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">The daily workload of the clinic is between 250 to 300 per regular clinic day (Monday, Tuesday and Friday) comprising adults 35 years old and above. 180 to 250 youths are seen on Wednesday (youth day age 20- 35 yrs) and 70 to 150 adolescents are seen on Thursdays.<o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 7.5pt; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">The CCC also runs viremia clinics for patient with high viral loads on first-line therapy every Wednesday while Fridays are reserved for clients failing second-line treatment.<o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 7.5pt; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">The medical officer is the in-charge of the clinic and works closely with the matron and the pharmacist in charge of the PSC Pharmacy. <o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 7.5pt; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">The clinic has been integrated and most of the services are offered within CCC which includes, clinical, nursing, adherence counseling, nutrition, community and linkage to OVC, cervical cancer screening amongst others. <o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 7.5pt; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">JOOTRH is also the hub center for the regional Nyanza-Western technical working group meetings held every 2^nd Monday of the month. It is also the spokes hub for ECHO sessions held every Thursday at 3pm.<o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 7.5pt; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">There are 4 co-investigators in the B/F/TAF to 2DR Switch Study who are based at the site and 3 site-based study staff (2 study nurse/counsellors and a study clinical officer) have been engaged and are currently working at the CCC. The site currently has 105 PWH aged 60 years or older on B/F/TAF.<o:p></o:p></span></p>\n
      • other_details_explanation<p>\n Not applicable</p>\n
      • other_details_regulatory_notapproved<p>\n Not applicable</p>\n
      • other_details_regulatory_approved<p>\n Not applicable</p>\n
      • other_details_regulatory_rejected<p>\n Not applicable</p>\n
      • other_details_regulatory_halted<p>\n Not applicable</p>\n
      • estimated_duration2.5 years
      • 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_countriesNo
      • multiple_member_states
      • number_of_sites2
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_site105 at JOOTRH and 135 in KNH
      • total_participants_worldwide240
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyYes
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameLoice
      • investigator1_middle_nameAchieng
      • investigator1_family_nameOmbajo
      • investigator1_qualificationMBChB, MMED Internal Medicine, MSc Infectious Diseases
      • investigator1_professional_addressMBChB, MMED Internal Medicine, MSc Infectious Diseases
      • investigator1_telephone+254722576984
      • investigator1_emailloisea@uonbi.ac.ke
      • organisations_transferred_No
      • number_participants240
      • notification
      • approval_date02-06-2024
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted03-04-2024
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonReviewer comments have been addressed adequately.
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2024-07-30 11:20:21
      • created2024-03-14 10:26:11
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id1049
        • application_id1389
        • given_nameLoice
        • middle_nameAchieng
        • family_nameOmbajo
        • qualificationMBChB, MMED Internal Medicine, MSc Infectious Diseases
        • professional_addressP.O. Box 2304 - 00202 Nairobi, Kenya
        • telephone+254722576984
        • emailloisea@uonbi.ac.ke
        • created2024-03-14 10:42:12
        • modified2024-04-03 13:18:57
    • SiteDetail(array)
      • 0(array)
        • id1685
        • application_id1389
        • county_id42
        • site_nameJaramogi Oginga Odinga Teaching and Referral Hospital
        • physical_addressPatient Support Centre, Jomo Kenyatta Highway, Kaloleni, Kisumu
        • contact_detailsP.O. Box 849 - 40100, Kisumu
        • contact_personDr Florentius Ndinya
        • site_capacity(null)
        • misc(null)
        • created2024-03-14 10:42:12
        • modified2024-04-03 13:18:57
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
      • 1(array)
        • id1686
        • application_id1389
        • county_id47
        • site_nameKenyatta National Hospital
        • physical_addressComprehensive Care Centre, Hospital Road, Nairobi
        • contact_detailsP.O. Box 20723 - 00202, Nairobi
        • contact_personDr Loice Achieng Ombajo
        • site_capacity(null)
        • misc(null)
        • created2024-03-14 11:48:06
        • modified2024-04-03 13:18:57
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
    • Sponsor(array)
      • 0(array)
        • id733
        • application_id1389
        • sponsorUniversity of Niarobi
        • sponsor_typeResearch Institution
        • contact_personProf Erastus Amayo
        • addressP.O. Box 19676 - 00202 Nairobi, Kenya
        • telephone_number+254204915041
        • fax_number
        • cell_number+254733611557
        • email_addresserastus.amayo@uonbi.ac.ke
        • created2024-03-14 10:42:12
        • modified2024-04-03 13:18:57
  • 1(array)
    • Application(array)
      • id1388
      • user_id613
      • trial_status_id1
      • abstract_of_study<p>\n Multidrug resistant TB (MDR TB) has been on the rise worldwide with WHO estimating that there were 480000 cases worldwide in the year 2015. MDR TB is of global significance due to associated high mortality rates and toxicity associated with drugs used for treatment. Therefore, there is need to prevent contacts of index cases from contracting the disease</p>\n<p>\n A5300B is a Phase III, open-label, multicenter trial with a cluster-randomized superiority design (eligible contacts in the same HH are a cluster) to compare the efficacy and safety of 26 weeks of DLM versus 26 weeks of INH for preventing confirmed or probable active TB during 96 weeks of follow-up among HIV-infected and other high-risk HHCs of adults with MDR-TB (index case).</p>\n<p>\n The study will enroll adults (≥18 years) with MDR TB and their house hold contacts. Index case is defined as patient with confirmed rifampicin and isoniazid resistance. House hold contacts are individuals who currently lives or lived in the same dwelling unit or plot of land and shares or has shared the same housekeeping arrangements as the index case and who report exposure within 90 days prior to index case starting MDR –TB treatment. The house hold contacts are children aged < 5years of age or adults, adolescents and children aged above 5 years who are LTBI positive.</p>\n<p>\n  </p>\n<p>\n Globally, a target of 5610 participants will be enrolled (1726 index cases and 3452 contacts) and each participant will remain in the study for a period of 96 weeks. Kericho site anticipates to screen 100 potential index cases to enroll 70 index cases and 280 contacts</p>\n
      • study_title<p align=\"center\">\n <strong><u>P</u></strong><strong>rotecting <u>H</u>ouseholds <u>O</u>n <u>E</u>xposure to <u>N</u>ewly Diagnosed <u>I</u>nde<u>x</u> Multidrug-Resistant Tuberculosis Patients (PHOENIx MDR-TB)</strong></p>\n
      • laymans_summary<p>\n <strong>Title: </strong>Protecting Households On Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients (PHOENIx MDR-TB)</p>\n<p>\n <strong>Lay title</strong>: A study comparing the safety and efficacy of two drugs for preventing confirmed or probable active TB among house hold contacts of patients with MDR-TB.</p>\n<p>\n A Phase III, open-label, multicenter trial with a cluster-randomized superiority design (eligible contacts in the same household [HH] are a cluster), to compare the efficacy and safety of 26 weeks of delamanid (DLM) versus 26 weeks of isoniazid (INH) for preventing confirmed or probable active TB during 96 weeks of follow-up among high-risk household contacts (HHCs) of adults with multidrug-resistant tuberculosis (MDR-TB). High-risk HHCs are those with HIV or non-HIV immunosuppression, latent TB infection, and young children below the age of 5 years.</p>\n<p>\n Approximately 5610 (2158 index cases and 3452 household contacts) will be enrolled into the study globally. The Kericho site anticipates to enroll up to 350 participants</p>\n
      • short_titlePHOENIx MDR-TB)
      • protocol_noECCT/24/03/06
      • version_no4.0
      • date_of_protocol30-11-2022
      • study_drugdelamanid
      • disease_conditionMDR TB
      • product_type_biologicals1
      • product_type_proteins1
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device0
      • product_type_chemical_nameDelamanid
      • product_type_medical_device_name
      • comparatorYes
      • comparator_nameStandard of care Isoniazid
      • comparator_registeredyes
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressKericho.DRS@usamru-k.org
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries(null)
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan1
      • applicant_contractual_agreement1
      • declaration_applicantDr Lucy Koech
      • declaration_date113-03-2024
      • declaration_principal_investigatorDr Lucy Koech
      • declaration_date213-03-2024
      • placebo_presentNo
      • study_objectives<h3>\n To compare the efficacy of 26 weeks of DLM versus 26 weeks of INH for preventing confirmed or probable active TB during 96 weeks of follow-up.</h3>\n<p>\n  </p>\n<h3>\n To compare the safety (permanently stopping study drug due to treatment-related adverse events) of 26 weeks of DLM versus 26 weeks of INH for the treatment of presumed latent TB infection (LTBI) with MDR-TB.</h3>\n<p>\n  </p>\n
      • principal_inclusion_criteria<div>\n  </div>\n<div>\n Started MDR-TB treatment within the past 90 days.</div>\n<div>\n Ability and willingness of the index case to provide informed consent to access</div>\n<div>\n the HH and approach HH members for evaluation</div>\n<div>\n Men and women age ≥18 years</div>\n
      • principal_exclusion_criteria<div>\n Has previously enrolled into the A5300B/I2003B/PHOENIx trial as an index case</div>\n<div>\n or HHC, or is a member of a HH which has previously enrolled into the</div>\n<div>\n A5300B/I2003B/PHOENIx trial.</div>\n<div>\n  </div>\n
      • primary_end_points<p>\n <em>The study endpoints are detailed in the parent protocol pages 72-83.</em></p>\n
      • scope_diagnosis1
      • scope_prophylaxis1
      • scope_therapy1
      • scope_safety0
      • scope_efficacy0
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic1
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other1
      • trial_other_specifyPhase 3
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory1
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n PhD - 1</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n MMED - 2</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n MSc - 10</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n BSc - 20</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Diploma - 50</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n CAP Certified Laboratory</p>\n
      • other_details_explanation
      • other_details_regulatory_notapproved<p>\n WRAIR and KEMRI SERU</p>\n
      • other_details_regulatory_approved<p>\n Awaiting KEMRI/SERU approval</p>\n
      • other_details_regulatory_rejected<p>\n None</p>\n
      • other_details_regulatory_halted<p>\n None</p>\n
      • estimated_durationParticipant followed up for 96 Weeks
      • design_controlled_randomisedYes
      • 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_comparatorISONIAZID
      • 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_statesAfrica. ASIA, South America
      • number_of_sites2
      • multi_country_listKenya, South Africa, Malawi, Botswana, Uganda, Peru, Haiti, Vietnam and Tanzania
      • data_monitoring_committeeYes
      • total_enrolment_per_site350
      • total_participants_worldwide5610
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornYes
      • population_newbornYes
      • population_infant_and_toddlerYes
      • population_childrenYes
      • population_adolescentYes
      • 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_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameDr Fredrick Sawe
      • investigator1_middle_name
      • investigator1_family_nameSAWE
      • investigator1_qualification MBChB, MMED
      • investigator1_professional_addressKenya Medical Research Institute/Walter Reed Project P.O Box 1357 – 20200,
      • investigator1_telephone+254 703247902
      • investigator1_emailFredrick.sawe@usamru-k.org
      • organisations_transferred_No
      • number_participants350
      • notification
      • approval_date21-05-2024
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted17-05-2024
      • unsubmitted1
      • initial_date_submitted07-05-2024
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonReviewer comments have been addressed and approved by two (2) reviewers.
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2024-09-24 10:03:43
      • created2024-03-13 08:59:16
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id1048
        • application_id1388
        • given_nameDr Lucy Chepkurui Koech
        • middle_name
        • family_nameKOECH
        • qualificationMBChB
        • professional_addressKenya Medical Research Institute/Walter Reed Project P.O Box 1357 – 20200,
        • telephone+254 719193275
        • emailLucy.koech@usamru-k.org
        • created2024-03-13 10:10:19
        • modified2024-05-17 12:46:39
    • SiteDetail(array)
      • 0(array)
        • id1684
        • application_id1388
        • county_id35
        • site_nameKenya medical Research Institute/ Walter Reed Project
        • physical_addressOFF Hospital Road
        • contact_detailsP.O. BOX 1357 Kericho
        • contact_personDr Lucy C. Koech
        • site_capacity(null)
        • misc(null)
        • created2024-03-13 10:10:19
        • modified2024-05-17 12:46:39
        • County(array)
          • id35
          • county_nameKericho
          • created2012-06-15 10:26:16
          • modified2012-06-15 10:26:16
      • 1(array)
        • id1712
        • application_id1388
        • county_id27
        • site_nameMoi university clinic research Centre
        • physical_addressAmpath Centre at MTRH
        • contact_detailsP.O.BOX 4604 Eldoret
        • contact_personDr Abraham Mosigisi Siika
        • site_capacity(null)
        • misc(null)
        • created2024-05-17 11:11:31
        • modified2024-05-17 12:46:39
        • County(array)
          • id27
          • county_nameUasin Gishu
          • created2012-06-15 10:25:15
          • modified2012-06-15 10:25:15
    • Sponsor(array)
      • 0(array)
        • id732
        • application_id1388
        • sponsorNational Institute of Allergy and Infectious Diseases National Institute of Child Health and Human Development
        • sponsor_typeResearch Institution
        • contact_person
        • addressACTGIMPAACT.COREPHOENIX@fstrf.org
        • telephone_number301-897-1707.
        • fax_number
        • cell_number301-897-1707.
        • email_addressACTGIMPAACT.COREPHOENIX@fstrf.org
        • created2024-03-13 10:10:19
        • modified2024-05-17 12:46:39
  • 2(array)
    • Application(array)
      • id1387
      • user_id667
      • trial_status_id1
      • abstract_of_study<p>\n <strong>Background: </strong>With availability of simplified and potent ART treatment regimens, HIV-1 infection has become a chronic, manageable condition, and PLWH receiving effective ART regimens can expect to live near-normal lifespans. Anticipating that individuals can receive decades of treatment during their lifetime, long-term tolerability and safety of antiretrovirals have become increasingly important considerations. The current standard-of-care for the treatment of HIV-1 is a combination of 2 Nucleoside Reverse Transcriptase Inhibitors with a third agent (e.g., integrase strand transfer inhibitors, Non-Nucleoside Reverse Transcriptase Inhibitor, or Protease Inhibitor). Although such regimens have become increasingly well tolerated and highly efficacious, the current paradigm of lifelong daily treatment is associated with a need for simpler and safer regimens that reduce overall drug exposure. There is evidence that 2-drug regimens can achieve efficacy that is comparable to that of 3-drug regimens, offer better tolerability, and improve quality of life, all of which can support adherence and help to sustain virologic suppression.</p>\n<p>\n <strong>Objectives:</strong>  The primary objective of this study is to evaluate the antiretroviral activity, safety and tolerability of Doravirine/Islatravir<strong> (</strong>DOR/ISL) compared to Bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF), as assessed by the percentage of participants with HIV-1 RNA <50 copies/mL at Week 48. These will be measured by laboratory-confirmed HIV-1 RNA, adverse events including adverse events leading to discontinuation of study intervention.</p>\n<p>\n <strong>Methods:</strong> This is a Phase 3, randomized, active-controlled, multi-site, double-blind study to evaluate the antiretroviral activity, safety, and tolerability of daily DOR/ISL in treatment naïve participants with HIV-1. The active control selected for this study is the 3-drug combination of daily BIC/FTC/TAF with demonstrated antiretroviral activity against HIV-1 in treatment naïve patients. Globally, approximately 500 participants will be randomized, stratified by screening HIV-1 RNA level (≤100,000 copies/mL, >100,000 copies/mL) and screening CD4+ T-cell count (<200 cells/mm³, ≥200 cells/mm³), in a 1:1 ratio into 1 of 2 treatment groups. All participants will receive 96 weeks of assigned therapy. Three sites in Kenya (Kisumu CGHR, KEMRI-CCR PHRD, Thika and KEMRI-CCR Nairobi) will take part in Part 2 of study enrolment that is planned to start in May 2024 and cumulatively enroll 30 participants, approximately 10 per site.</p>\n<p>\n <strong>Expected results:</strong> For our primary objectives, we hypothesize that DOR/ISL is non- inferior to BIC/FTC/TAF, as assessed by the percentage of participants with HIV-1 RNA <50 copies/mL at Week 48. A margin of 10 percentage points will be used to define non-inferiority.</p>\n
      • study_title<div>\n A Phase 3, Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate the Antiretroviral Activity, Safety, and Tolerability of Doravirine/Islatravir (DOR/ISL 100 mg/0.25 mg) Once-Daily in HIV-1 Infected Treatment-Naïve Participants</div>\n
      • laymans_summary<p>\n There has been evolution in the medications for treating HIV-1 infection with life expectancy among persons living with HIV (PLWH) getting closer to those of the uninfected population. Currently, the standard of care for treating of HIV-1 infection is a 3-drug combination. Although these medications are working well, the potential for long-term toxicity cannot be excluded. Therefore, there is need for simpler and safer combinations that reduce overall drug exposure. There is evidence that 2-drug combination works in a comparable way to the 3-drug combination.</p>\n<p>\n We are conducting a phase 3 trial to look at the antiretroviral activity, safety and tolerability of a 2-drug combination of Doravirine/Islatravir compared to 3-drug combination of Bictegravir/emtricitabine/tenofovir alafenamide. This will be a clinical trial of approximately 500 participants newly diagnosed with HIV-1 infection and not started on any ART treatment across 24 treatment sites globally, with our site expected to enroll a minimum of 10 participants. Participants will be in two groups, i.e., a treatment group and a control group. The treatment group will receive the 2-drug combination while the control group will receive the 3-drug combination. All participants will be followed up for 96 weeks.</p>\n<p>\n At the end of the trial, we expect that the 2-drug combination will be non-inferior to the 3-drug combination in the treatment of HIV-1 infection.</p>\n
      • short_titleMK8591A-053 Trial
      • protocol_noECCT/24/03/04
      • version_no053-01
      • date_of_protocol24-10-2023
      • study_drugDoravirine/Islatravir (DOR/ISL) 100 mg/0.25 mg
      • disease_conditionHIV
      • 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_nameDoravirine + Islatravir
      • product_type_medical_device_name
      • comparatorYes
      • comparator_nameBictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) 50 mg/200 mg/25 mg
      • comparator_registeredYes
      • comparator_countriesKenya, Uganda, South Africa, USA, European Union, Australia, Canada, Argentina, Caribbean Regulatory System, Costa Rica, Dominican Republic, Mexico, Panama,
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressebukusi@kemri.go.ke
      • 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_applicantGreshon Rota
      • declaration_date108-03-2024
      • declaration_principal_investigatorElizabeth Anne Bukusi
      • declaration_date208-03-2024
      • placebo_presentYes
      • study_objectives<p>\n Primary Objectives:</p>\n<ol>\n <li>\n To evaluate the antiretroviral activity of DOR/ISL compared to BIC/FTC/TAF, as assessed by the percentage of participants with HIV-1 RNA <50 copies/mL at Week 48.</li>\n <li>\n To evaluate the safety and tolerability of DOR/ISL compared with BIC/FTC/TAF as assessed by review of the accumulated safety data through Week 48.</li>\n</ol>\n<p>\n SecondaryObjectives:</p>\n<ol>\n <li>\n To evaluate the antiretroviral activity of DOR/ISL compared with BIC/FTC/TAF, as assessed by the percentage of participants with HIV-1 RNA <50 copies/mL at Week 96.</li>\n <li>\n To evaluate the antiretroviral activity of DOR/ISL compared with BIC/FTC/TAF, as assessed by the percentage of participants with HIV-1 RNA <200 copies/mL at Week 48 and Week 96.</li>\n <li>\n To evaluate the immunologic effect of DOR/ISL compared with BIC/FTC/TAF, as assessed by the mean change from baseline in CD4+ T-cell count at Week 48 and Week 96.</li>\n <li>\n To evaluate the development of viral drug resistance in participants who receive DOR/ISL and in those who receive BIC/FTC/TAF.</li>\n <li>\n To evaluate the effect of DOR/ISL compared with BIC/FTC/TAF on weight, as assessed by the mean change from baseline to Week 48 and Week 96.</li>\n <li>\n To evaluate the safety and tolerability of DOR/ISL compared with BIC/FTC/TAF as assessed by review of the accumulated safety data through study duration.</li>\n</ol>\n<p>\n Tertiary/Exploratory Objectives:</p>\n<ol>\n <li>\n To evaluate the effects on body composition, fasting lipid and metabolic profiles, renal function, and inflammation of DOR/ISL compared with BIC/FTC/TAF, as assessed by the mean change from baseline to Week 48 and Week 96 in these parameters.</li>\n <li>\n To evaluate the pharmacokinetics of ISL when administered as a component of DOR/ISL.</li>\n <li>\n To describe PROs (assessing HRQoL and HIV symptoms) for participants who receive DOR/ISL compared with BIC/FTC/TAF at Week 48 and Week 96.</li>\n <li>\n To explore the relationship between genetic variation and response to the treatment(s) administered, and mechanism of disease. Variation across the human genome may be analyzed for association with clinical data collected in this study.</li>\n</ol>\n<p>\n  </p>\n
      • principal_inclusion_criteria<p>\n A participant is eligible for inclusion in the study if the participant meets all of the following criteria:</p>\n<p>\n <strong>Type of Participant and Disease Characteristics</strong></p>\n<p style=\"margin-left:54.0pt;\">\n 1        Is HIV-1 positive with plasma HIV-1 RNA ≥500 copies/mL at initial screening.</p>\n<p style=\"margin-left:54.0pt;\">\n 2        Is naïve to ART defined as having received no prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection.</p>\n<p>\n <strong>Demographics</strong></p>\n<p style=\"margin-left:54.0pt;\">\n 3        Is an individual of any sex/gender, at least 18 years of age, at the time of providing documented informed consent.</p>\n<p>\n <strong>Participants Assigned Female Sex at Birth</strong></p>\n<p style=\"margin-left:54.0pt;\">\n 4        A participant assigned female sex at birth is eligible to participate if not pregnant or breastfeeding, and at least one of the following conditions applies:</p>\n<p style=\"margin-left:24.0pt;\">\n •         Is not a participant(s) of childbearing potential (POCBP)</p>\n<p style=\"margin-left:24.0pt;\">\n OR</p>\n<p style=\"margin-left:24.0pt;\">\n •         Is a POCBP and:</p>\n<p style=\"margin-left:42.0pt;\">\n -          Uses an acceptable contraceptive method or is abstinent from penile-vaginal intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis), as described in Appendix 5 during the intervention period and for at least 6 weeks after the last dose of study intervention. The investigator should evaluate the potential for contraceptive method failure (i.e., noncompliance, recently initiated) in relationship to the first dose of study intervention. Contraceptive use by POCBPs should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. If the contraception requirements in the local label for any of the study interventions are more stringent than the requirements above, the local label requirements are to be followed.</p>\n<p style=\"margin-left:42.0pt;\">\n -          Has a negative highly sensitive pregnancy test (urine or serum as required by local regulations) within 24 hours (for urine test) or 72 hours (for serum test) before the first dose of study intervention. If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy test result is positive.</p>\n<p style=\"margin-left:42.0pt;\">\n -          Medical history, menstrual history, and recent sexual activity has been reviewed by the investigator to decrease the risk for inclusion of a POCBP with an early undetected pregnancy.</p>\n<p>\n <strong>Informed Consent</strong></p>\n<p>\n The participant (or legally acceptable representative) has provided documented informed consent for the study. The participant may also provide consent for future biomedical research. However, the participant may participate in the study without participating in future biomedical research.</p>\n
      • principal_exclusion_criteria<p>\n The participant must be excluded from the study if the participant meets any of the following criteria:</p>\n<p>\n <strong>Medical Conditions</strong></p>\n<ol>\n <li>\n Has HIV-2 infection.</li>\n <li>\n Has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator.</li>\n <li>\n Has a diagnosis of an active AIDS-defining opportunistic infection within 30 days prior to screening.</li>\n <li>\n Has active hepatitis B virus (HBV) infection (defined as HBsAg-positive or HBV DNA-positive).</li>\n <li>\n Has chronic hepatitis C virus (HCV) infection (detectable HCV RNA) with laboratory values consistent with cirrhosis (serum albumin <2.8 g/dL or INR >1.7 or platelets <100 x 10⁹ cells/L).</li>\n <li>\n Has a history of malignancy ≤5 years prior to providing documented informed consent except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or cutaneous Kaposi’s sarcoma.</li>\n <li>\n Has a history or current evidence of any condition (including active tuberculosis infection), therapy, any laboratory abnormality, or other circumstance (including drug or alcohol use or dependence) that might, in the opinion of the investigator, confound the results of the study or interfere with the participant’s participation for the full duration of the study, such that it is not in the best interest of the participant to participate.</li>\n</ol>\n<p>\n <strong>Prior/Concomitant Therapy</strong></p>\n<ol>\n <li value=\"8\">\n Has been treated for a viral infection other than HIV-1, such as hepatitis B, with an agent that is active against HIV-1, including, but not limited to, the following: adefovir, TDF, TAF, FTC, or 3TC.</li>\n <li value=\"9\">\n Is taking or is anticipated to require systemic immunosuppressive therapy, immune modulators, or strong and moderate CYP3A inducers (or any other prohibited therapies outlined in Section 6.5 of the main protocol) from 45 days prior to Day 1 through the study treatment period.</li>\n</ol>\n<p>\n <strong>Prior/Concurrent Clinical Study Experience</strong></p>\n<ol>\n <li value=\"10\">\n Is currently participating in or has participated in a clinical study and received (or is receiving) an investigational compound or device from 45 days prior to Day 1 through the study treatment period.</li>\n</ol>\n<p>\n <strong>Diagnostic Assessments</strong></p>\n<ol>\n <li value=\"11\">\n Has a documented or known virologic resistance to any approved HIV-1 reverse transcriptase inhibitor, or any study intervention, as demonstrated by any of the following resistance substitutions (according to the 2017 IAS-USA drug resistance mutations list) [Wensing, A. M., et al 2017]:\n <ul>\n <li>\n FTC: K65R/E/N or M184I/V</li>\n <li>\n TAF: K65R/E/N or K70E</li>\n <li>\n NRTI resistance substitutions: T69insert, Q151M, or 3 or more of thymidine analogue-associated mutations (M41L, D67N, K70R, L210W, T215F/Y, K219E/Q).</li>\n <li>\n DOR resistance substitutions: V106A/M, V108I, Y188L, H221Y, P225H, F227C/ L/V, M230I/L, L234I, P236L, or Y318F.</li>\n </ul>\n </li>\n <li value=\"12\">\n Has exclusionary laboratory values within 45 days prior to Day 1 as listed in table below:</li>\n</ol>\n<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\" width=\"598\">\n <tbody>\n <tr>\n <td colspan=\"2\" style=\"width:598px;height:25px;\">\n <p>\n <strong>Table 1. Laboratory assessment and exclusion values</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:294px;height:25px;\">\n <p>\n <strong>Laboratory Assessment</strong></p>\n </td>\n <td style=\"width:304px;height:25px;\">\n <p>\n <strong>Exclusionary Values</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:294px;height:25px;\">\n <p>\n ALP</p>\n </td>\n <td style=\"width:304px;height:25px;\">\n <p>\n >3 × ULN</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:294px;height:25px;\">\n <p>\n AST</p>\n </td>\n <td style=\"width:304px;height:25px;\">\n <p>\n >5 × ULN</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:294px;height:25px;\">\n <p>\n ALT</p>\n </td>\n <td style=\"width:304px;height:25px;\">\n <p>\n >5 × ULN</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:294px;height:42px;\">\n <p>\n Calculated CrCL</p>\n </td>\n <td style=\"width:304px;height:42px;\">\n <p>\n ≤30 mL/min based on the Cockcroft-Gault equation (Appendix 8)</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:294px;height:25px;\">\n <p>\n Hemoglobin</p>\n </td>\n <td style=\"width:304px;height:25px;\">\n <p>\n <9.0 g/dL (female) or <10.0 g/dL (male)</p>\n </td>\n </tr>\n <tr>\n <td colspan=\"2\" style=\"width:598px;height:39px;\">\n <p>\n ALP=alkaline phosphatase; ALT=alanine aminotransferase; AST=aspartate aminotransferase; CrCL=creatinine clearance; ULN=upper limit of normal.</p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n
      • primary_end_points<ol>\n <li>\n HIV-1 RNA <50 copies/mL measured at Week 48.</li>\n <li>\n Adverse events</li>\n <li>\n Adverse events leading to discontinuation of study intervention</li>\n</ol>\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 Site 8650 Kisumu: The site has 43 Staff with 14 deciated to the study activities</p>\n<p>\n Site 8651 Thika: The site has 52 Staff with 12 dedicated to the study activities</p>\n<p>\n Site 8652 Nairobi: The site has 63  Staff with 15 deciated to the study activities</p>\n<p>\n  </p>\n<p>\n For the specific roles and site capacity, kindly see the site-specific addendum attached.</p>\n
      • other_details_explanation<p>\n N/A</p>\n
      • other_details_regulatory_notapproved<p>\n None</p>\n
      • other_details_regulatory_approved<p>\n South African Health Products Regulatory Authority (SAHPRA)</p>\n
      • other_details_regulatory_rejected<p>\n None</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration36 months
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindNo
      • design_controlled_double_blindYes
      • design_controlled_parallel_groupYes
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorBIC/FTC/TAF
      • design_controlled_other_medicinalYes
      • design_controlled_placeboYes
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesYes
      • multiple_member_states14
      • number_of_sites3
      • multi_country_listSouth Africa\nKenya
      • data_monitoring_committeeYes
      • total_enrolment_per_site10
      • total_participants_worldwide500
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyYes
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameElizabeth
      • investigator1_middle_nameAnne
      • investigator1_family_nameBukusi
      • investigator1_qualificationMBChB, M.Med (ObGyn), MPH, PhD, PGD (Research Ethics), MBE (Research Ethics)
      • investigator1_professional_addressKenya Medical Research Institute (KEMRI) P.O. Box 54840 00200, Off Raila Odinga Way, Nairobi, Kenya
      • investigator1_telephone+254 733617503
      • investigator1_emailebukusi@kemri.go.ke
      • organisations_transferred_Yes
      • number_participants30
      • notification
      • approval_date19-06-2024
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted30-05-2024
      • unsubmitted1
      • initial_date_submitted21-03-2024
      • 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)
      • modified2024-09-30 19:40:09
      • created2024-03-08 06:49:24
      • total_sites(null)
      • ecitizen_invoice321058
    • InvestigatorContact(array)
      • 0(array)
        • id1046
        • application_id1387
        • given_nameElizabeth
        • middle_nameAnne
        • family_nameBukusi
        • qualificationMBChB, M.Med (ObGyn), MPH, PhD, PGD (Research Ethics), MBE (Research Ethics)
        • professional_addressKenya Medical Research Institute (KEMRI) P.O. Box 54840 00200, Off Raila Odinga Way, Nairobi, Kenya
        • telephone+254 733617503
        • emailebukusi@kemri.go.ke
        • created2024-03-08 07:24:56
        • modified2024-05-30 13:05:00
      • 1(array)
        • id1047
        • application_id1387
        • given_nameNelly
        • middle_nameRwamba
        • family_nameMugo
        • qualificationMBChB, MMED, MPH
        • professional_addressKenya Medical Research Institute (KEMRI) P.O. Box 54840 00200, Off Raila Odinga Way, Nairobi, Kenya
        • telephone+254 733629665
        • emailrwamba@uw.edu
        • created2024-03-08 07:33:20
        • modified2024-05-30 13:05:00
    • SiteDetail(array)
      • 0(array)
        • id1681
        • application_id1387
        • county_id42
        • site_nameSite 8650, KEMRI-CMR-RCTP, Kisumu
        • physical_addressLumumba Subcounty Hospital, Kisumu
        • contact_details+254799580808, P.O. Box 614, 40100, Kisumu, Kenya
        • contact_personDr Victor Omollo
        • site_capacity(null)
        • misc(null)
        • created2024-03-08 07:24:56
        • modified2024-05-30 13:05:00
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
      • 1(array)
        • id1682
        • application_id1387
        • county_id22
        • site_nameSite 8651, KEMRI-CCR-PHRD, Thika
        • physical_addressThika Section 9, OAU Road
        • contact_details+254722362219, P.O. Box 62000, 00200, Nairobi, Kenya
        • contact_personProf Kenneth Ngure
        • site_capacity(null)
        • misc(null)
        • created2024-03-08 08:15:52
        • modified2024-05-30 13:05:00
        • County(array)
          • id22
          • county_nameKiambu
          • created2012-06-15 10:24:37
          • modified2012-06-15 10:24:37
      • 2(array)
        • id1683
        • application_id1387
        • county_id47
        • site_nameSite 8652, KEMRI-CCR, NAIROBI
        • physical_addressOff Raila Odinga Way
        • contact_details+254722800693, P.O. Box 54840, 00200, Nairobi, Kenya
        • contact_personDr Betty Njoroge
        • site_capacity(null)
        • misc(null)
        • created2024-03-08 08:15:52
        • modified2024-05-30 13:05:00
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
    • Sponsor(array)
      • 0(array)
        • id731
        • application_id1387
        • sponsorMSD (PTY) LTD
        • sponsor_typeIndustry
        • contact_personZablon Omungo
        • address117 16th Road, Midrand, 1685, Gauteng, South Africa; Private Bag 3, Halfway House, 1685, Gauteng, South Africa
        • telephone_number+254734610909
        • fax_number
        • cell_number+254725873088
        • email_addresszablon.omungo@merck.com
        • created2024-03-08 07:24:56
        • modified2024-05-30 13:05:00
  • 3(array)
    • Application(array)
      • id1386
      • user_id693
      • trial_status_id2
      • abstract_of_study<div>\n Respiratory syncytial virus (RSV) is the most important cause of severe acute lower respiratory illness in infants and children and the most common cause of severe</div>\n<div>\n pneumonia requiring hospital admission in children worldwide. According to global estimates, RSV caused approximately 33 million cases of lower respiratory illness and approximately 118,000 deaths in children < 5 years of age in 2015.Infants and young children are at increased risk for RSV infections because of their maturing immune system and lack of prior exposure to RSV.</div>\n<div>\n A genetically stable live-attenuated RSV ΔNS2/Δ1313/I1314L vaccine has been shown to be safe and immunogenic in RSV-seronegative children in Phase I studies with further research ongoing in RSV-seropositive children. Sanofi is conducting clinical studies with a similar RSV ΔNS2/Δ1313/I1314L vaccine, referred to as RSVt vaccine, as part of the Phase III development of the RSVt vaccine (the VAD0004 study).</div>\n<div>\n  </div>\n<div>\n The VAD0004 study, is a Phase III, randomized, observer-blind, placebo-controlled, multi-center, multinational study to evaluate the efficacy, immunogenicity, and safety of a Respiratory Syncytial Virus vaccine in infants and toddlers. The study is designed to evaluate the efficacy, immunogenicity, and safety of RSVt vaccine administered by intranasal route and compared to placebo.</div>\n<div>\n Overall, a global sample size of approximately 6300 participants 6 months to < 22 months of age will be enrolled in the study. Kenya site will enroll approximately 1500 participants. Eligible participants will be randomized in a 1:1 ratio to receive 2 intranasal administrations of either the RSVt vaccine or placebo.Study duration will be 24months for each participant. The safety evaluation will start after the first vaccination and up to the end of the study. The trial will target recruitment of people from different races and ethnic groups that at a minimum will be representative of the countries in which the trial will be conducted.</div>\n
      • study_title<div>\n Phase III, randomized, observer-blind, placebo-controlled, multi-center, multinational study to evaluate the efficacy, immunogenicity, and safety of a Respiratory Syncytial Virus vaccine in infants and toddlers (PEARL</div>\n
      • laymans_summary<div>\n Respiratory Syncytial Virus (RSV) is a contagious virus (germ) that circulates particularly during the winter months and throughout the year in some parts of the world. It is transmitted through droplets containing the virus when someone infected sneezes or coughs. In most infants, the RSV infection will be a mild illness similar to a cold, with symptoms such as fever, runny nose, sore throat, ear infection, cough, and croup (barky cough with hoarseness). In some cases, RSV can cause serious lung illnesses such as pneumonia and bronchiolitis (an infection of small airways in the lung called bronchioles), which may lead to hospitalization. At this time, there is no approved vaccine to prevent RSV illness.</div>\n<div>\n  </div>\n<div>\n Sanofi Pasteur is developing a vaccine called the RSVt vaccine. The study is called VAD00004 and is a Phase III trial, with two study arms, multiple research sites in multiple countries. in Kenya there are a total of 7 sites. It will be conducted in infants and toddlers 6 months to less than 22 months of age to evaluate if the vaccine works, how safe it is and how the human body responds to protect itself following vaccination of 2 intranasal spray of RSVt vaccine. The trial is designed to demonstrate how the vaccine works in preventing the occurrence of respiratory syncytial Virus.</div>\n<div>\n  </div>\n<div>\n The investigational RSVt vaccine in this study contains a live, weakened form of the virus (that is, attenuated) and is given as a nasal spray. It is made to help a person’s body respond in a way that will protect them from getting sick from the virus. The vaccine has been tested in humans before, and other live attenuated RSV vaccines very similar to this one has also been tested in both adults and children.</div>\n<div>\n A total of 6300 children are planned to be enrolled worldwide. Eligible participants will be randomized in a 1:1 ratio to receive 2 intranasal administrations 56 days apart of either the RSVt vaccine or placebo at day 1 and day 57 of the study. Additional illness visits may occur during the study for those who develops RSV like symptoms. Each participant will be followed for 24 months in the study. Kenya will enroll approximately 15000 up to 1000 children.</div>\n<div>\n  </div>\n<div>\n The trial will target recruitment of people from different races and ethnic groups that at a minimum will be representative of the countries in which the trial will be conducted.</div>\n
      • short_titlePEARL RSVt Vaccine Study
      • protocol_noECCT/24/03/02
      • version_noVersion 2.0
      • date_of_protocol30-06-2023
      • study_drugRSVt _ Dr Oyieko Janet
      • disease_conditionRespiratory syncytial virus (RSV)
      • product_type_biologicals1
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines1
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical0
      • product_type_medical_device0
      • product_type_chemical_name
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressPPDSubmissionsMembers.SM@ppd.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_applicantMillicent Aketch
      • declaration_date106-03-2024
      • declaration_principal_investigatorDr Fredrick Sawe
      • declaration_date206-03-2024
      • placebo_presentYes
      • study_objectives<div>\n Efficacy</div>\n<div>\n 1. To demonstrate the clinical</div>\n<div>\n efficacy of RSVt vaccine for</div>\n<div>\n the prevention of RT-PCR</div>\n<div>\n confirmed RSV LRTD after</div>\n<div>\n 2 doses, over RSV Season 1</div>\n<div>\n Secondary Objective</div>\n<div>\n Efficacy</div>\n<div>\n 1. To demonstrate the clinical efficacy of RSVt vaccine for</div>\n<div>\n the prevention of RT-PCR confirmed RSV URTD after2 doses over RSV Season† 1</div>\n<div>\n 2. To demonstrate the clinical efficacy of RSVt vaccine for</div>\n<div>\n the prevention of RT-PCR confirmed RSV associated</div>\n<div>\n with the occurrence of LRTD, leading to hospitObjectives Endpoints</div>\n<div>\n 3. To describe the clinical efficacy of RSVt vaccine for the</div>\n<div>\n prevention of RT-PCR confirmed RSV severe LRTD after</div>\n<div>\n 2 doses over RSV Season 1</div>\n<div>\n 4. To describe the clinical efficacy of RSVt vaccine for the</div>\n<div>\n prevention of RT-PCR confirmed RSV LRTD after</div>\n<div>\n 2 doses over RSV Season 1, necessitating urgent care</div>\n<div>\n 5. To describe the clinical efficacy of RSVt vaccine for the</div>\n<div>\n prevention of RT PCR confirmed RSV ARD after 2 doses</div>\n<div>\n over RSV Season 1</div>\n<div>\n 6. To describe the clinical efficacy of RSVt vaccine for</div>\n<div>\n the prevention of RT-PCR confirmed RSV ARD after</div>\n<div>\n 2 doses over RSV Season 1, leading to hospitalization</div>\n<div>\n 7. To describe the clinical efficacy of RSVt vaccine for the</div>\n<div>\n prevention of RT-PCR confirmed RSV ARD after 2 doses</div>\n<div>\n over RSV Season 1, necessitating urgent care</div>\n<div>\n 8. To describe the clinical efficacy of RSVt vaccine for the</div>\n<div>\n prevention of RT-PCR confirmed RSV LRTD, by RSV</div>\n<div>\n strain after 2 doses over RSV Season 1</div>\n<div>\n 9. To describe the clinical efficacy of RSVt vaccine for the</div>\n<div>\n prevention of RT-PCR confirmed RSV URTD, by RSV</div>\n<div>\n strain after 2 doses over RSV Season 1</div>\n<div>\n 10. To describe the clinical efficacy of RSVt vaccine for the</div>\n<div>\n prevention of RT-PCR confirmed RSV ARD, by RSV</div>\n<div>\n strain after 2 doses over RSV Season 1</div>\n<div>\n 11. To describe the clinical efficacy of RSVt vaccine for the</div>\n<div>\n prevention of RT-PCR confirmed RSV LRTD after at least</div>\n<div>\n one dose, over RSV Season 1</div>\n<div>\n 12. To describe the clinical efficacy of RSVt vaccine for the</div>\n<div>\n Pharmaceutical</div>\n<div>\n form</div>\n<div>\n Route of administration</div>\n<div>\n Composition, apart from active</div>\n<div>\n substance(s)</div>\n<div>\n Is it otherwise identical to the</div>\n<div>\n INDP?</div>\n<div>\n If not, specify major</div>\n<div>\n ingredients</div>\n<div>\n 1</div>\n<div>\n Liquid for nasal spray</div>\n<div>\n Intranasal</div>\n<div>\n Histidine-based formulation buffer (including monosodium glutamate, sodium chloride and L-histidine)</div>\n<div>\n Yes</div>\n<div>\n prevention of RT-PCR confirmed RSV URTD after at least</div>\n<div>\n one dose, over RSV Season 1</div>\n<div>\n 13. To describe the clinical efficacy of RSVt vaccine for the</div>\n<div>\n prevention of RT-PCR confirmed RSV ARD after at least</div>\n<div>\n one dose, over RSV Season 1</div>\n<div>\n 14. To describe the clinical efficacy of RSVt vaccine for the</div>\n<div>\n prevention of RT-PCR confirmed RSV LRTD after 2</div>\n<div>\n doses over RSV Season 2</div>\n<div>\n 15. To describe the clinical efficacy of RSVt vaccine for the</div>\n<div>\n prevention of RT-PCR confirmed RSV URTD after 2</div>\n<div>\n doses over RSV Season 2</div>\n<div>\n 16. To describe the clinical efficacy of RSVt vaccine for the</div>\n<div>\n prevention of RT-PCR confirmed RSV ARD after 2 doses</div>\n<div>\n over RSV Season 2</div>\n<div>\n Safety</div>\n<div>\n 17. To describe the safety profile of the RSVt vaccine</div>\n<div>\n Immunogenicity</div>\n<div>\n 18. To describe the RSV A and B serum neutralizing and RSV</div>\n<div>\n serum anti-F IgA and IgG antibody responses to the study</div>\n<div>\n intervention</div>\n<div>\n Exploratory</div>\n<div>\n Efficacy Efficacy</div>\n<div>\n 1. To describe the clinical efficacy of RSVt vaccine for the</div>\n<div>\n prevention of RT-PCR confirmed RSV URTD after 2</div>\n<div>\n doses over RSV Season 1, leading to outpatient medical</div>\n<div>\n care, urgent care, or hospitalization.</div>\n<div>\n 2. To describe the clinical efficacy of RSVt vaccine for the</div>\n<div>\n prevention of RT-PCR confirmed RSV URTD after 2</div>\n<div>\n doses over RSV Season 1, leading to outpatient medical</div>\n<div>\n care</div>\n<div>\n 3. To describe the clinical efficacy of RSVt vaccine for the</div>\n<div>\n prevention of RT-PCR confirmed RSV ARD after 2 doses</div>\n<div>\n over RSV Season 1, leading to outpatient medical care</div>\n<div>\n 4. To describe the clinical efficacy of RSVt vaccine for the</div>\n<div>\n prevention of RT-PCR confirmed RSV LRTD after 2</div>\n<div>\n doses over RSV Season 2, leading to hospitalization</div>\n<div>\n 5. To describe the clinical efficacy of RSVt vaccine for the</div>\n<div>\n prevention of RT-PCR confirmed RSV severe LRTD after</div>\n<div>\n 2 doses over RSV Season 2</div>\n<div>\n 6. To describe the clinical efficacy of RSVt vaccine for the</div>\n<div>\n prevention of RT-PCR confirmed RSV ARD after 2 doses</div>\n<div>\n over RSV Season 2, leading to hospitalization</div>\n<div>\n 7. To describe the clinical efficacy of RSVt vaccine for the</div>\n<div>\n prevention of all-cause acute otitis media (AOM) after 2</div>\n<div>\n doses over RSV Season 1 and Season 2.</div>\n<div>\n Long-Term Immunogenicity</div>\n<div>\n 8. To describe the RSV A and B serum neutralizing and RSV</div>\n<div>\n serum anti-F IgA and IgG antibody responses to the study</div>\n<div>\n intervention at 3 months, 6 months, 1 year and 1.5 years</div>\n<div>\n after dose 2</div>\n<div>\n Immunogenicity</div>\n<div>\n 9. To estimate an immunological correlate of protection</div>\n<div>\n against RT-PCR confirmed RSV LRTD</div>\n<div>\n Safety</div>\n<div>\n 10. To assess the evidence of vaccine-enhanced RSV disease</div>\n<div>\n upon natural infection during both RSV Season 1 and RSV</div>\n<div>\n Season 2</div>\n<div>\n 10. Presence of Grade 1, 2, and 3 LRTD or ARD episodes (during both RSV Season 1 and RSV</div>\n<div>\n Season 2) associated with any RT-PCR confirmed RSV strain</div>\n<div>\n Other</div>\n<div>\n 11. To describe in each study intervention group the following</div>\n<div>\n events that are associated with cases of RT-PCR confirmed</div>\n<div>\n RSV ARD, associated with any RSV strain, over Season 1:</div>\n<div>\n ▪ recurrent wheezing</div>\n<div>\n ▪ pneumonia</div>\n<div>\n ▪ bronchiolitis</div>\n<div>\n ▪ AOM</div>\n<div>\n ▪ febrile illness</div>\n
      • principal_inclusion_criteria<div>\n Participants are eligible for the study only if all of the following criteria are met:</div>\n<div>\n AGE</div>\n<div>\n 1. Aged 6 months to < 22 months on the day of inclusion</div>\n<div>\n  </div>\n<div>\n  </div>\n<div>\n  </div>\n
      • principal_exclusion_criteria<div>\n MEDICAL CONDITIONS</div>\n<div>\n  </div>\n<div>\n E01. Known or suspected congenital or acquired immunodeficiency; or receipt of</div>\n<div>\n immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within</div>\n<div>\n the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or</div>\n<div>\n equivalent for more than 2 consecutive weeks within the past 3 months)</div>\n<div>\n E02. Known systemic hypersensitivity to any of the study intervention components, or history</div>\n<div>\n of a life-threatening reaction to the study intervention used in the study or to a product</div>\n<div>\n containing any of the same substances</div>\n<div>\n E03. Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere</div>\n<div>\n with study conduct or completionc</div>\n<div>\n E04. History of medically diagnosed wheezing</div>\n<div>\n E05. Any acute febrile illness in the past 48 hours that according to investigator judgment is</div>\n<div>\n significant enough to interfere with successful inoculation on the day of vaccination. A</div>\n<div>\n prospective participant should not be included in the study until the condition has resolved</div>\n<div>\n or the febrile event has subsided.</div>\n<div>\n E06. Probable or confirmed ongoing case of viral respiratory infection (including COVID-19,</div>\n<div>\n influenza, rhinovirus, etc.) at the time of enrollment. A prospective participant should not</div>\n<div>\n be included in the study until the respiratory infection has resolved.</div>\n<div>\n E07. Member of a household that contains an immunocompromised individual, including, but</div>\n<div>\n not limited to:</div>\n<div>\n • a person who is HIV infected</div>\n<div>\n • a person who has received chemotherapy within the 12 months prior to study</div>\n<div>\n enrollment</div>\n<div>\n • a person who has received (within the past 6 months) or is receiving (at the time of</div>\n<div>\n enrollment) immunosuppressant agents</div>\n<div>\n • a person living with a solid organ or bone marrow transplant</div>\n<div>\n Potential close contact with other immunocompromised individual within 30 days after</div>\n<div>\n each vaccination as per investigator’s discretion</div>\n<div>\n  </div>\n<div>\n PRIOR/CONCOMITANT THERAPY</div>\n<div>\n E08. Participant’s biological mother’s previous receipt or planned administration of an</div>\n<div>\n investigational RSV vaccine during pregnancy and/or breastfeeding.</div>\n<div>\n E09. Receipt or planned receipt of any of the following vaccines prior to enrollment or after the</div>\n<div>\n first study intervention administration:</div>\n<div>\n • Any other intranasal live attenuated vaccine within the 28 days prior to and after Dose</div>\n<div>\n 1 study administration</div>\n<div>\n • Unless given on the day of Dose 1 study administration, any other injectable live</div>\n<div>\n attenuated vaccines within the 28 days prior to and after. Concomitant receipt on the</div>\n<div>\n day of Dose 1 study administration is allowed.</div>\n<div>\n E10. Previous receipt of an investigational RSV vaccine or receiving any anti-RSV product</div>\n<div>\n (such as ribavirin or RSV immune globulin) at the time of enrollment. Previous receipt of</div>\n<div>\n an RSV monoclonal antibody within 6 months prior to the first study vaccine</div>\n<div>\n administration.</div>\n<div>\n E11. Receipt of immune globulins, blood or blood-derived products in the past 3 months</div>\n<div>\n E12. Receipt of intranasal and intra-ocular medications within 3 days prior to study enrollment</div>\n<div>\n PRIOR/CONCURRENT CLINICAL STUDY EXPERIENCE</div>\n<div>\n E13. Participation at the time of study enrollment or planned participation during the present</div>\n<div>\n study period in another clinical study investigating a vaccine, drug, medical device, or</div>\n<div>\n medical procedure</div>\n<div>\n  </div>\n<div>\n OTHER EXCLUSIONS</div>\n<div>\n  </div>\n<div>\n E14. Deprived of freedom in an emergency setting, or hospitalized involuntarily</div>\n<div>\n E15. Identified as a natural or adopted child of the Investigator or employee with direct</div>\n<div>\n involvement in the proposed study</div>\n
      • primary_end_points<div>\n Efficacy</div>\n<div>\n 1. Occurrence of LRTD (during RSV</div>\n<div>\n Season 1) associated with any RT-PCR</div>\n<div>\n confirmed RSV strain > 21 days post-dose 2</div>\n
      • scope_diagnosis0
      • scope_prophylaxis1
      • scope_therapy0
      • scope_safety1
      • scope_efficacy0
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others1
      • scope_others_specifyImmunogenicity
      • 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<div>\n KEMRI CCR-Butere</div>\n<div>\n  </div>\n<div>\n The site is housed within the premises of Butere County Hospital (BCH). It is designed to provide preventive and curative care</div>\n<div>\n for patients and has the capacity for regulated clinical trials. It has a full clinical laboratory including hematology, chemistry</div>\n<div>\n and microbiology capability. It is located in Butere sub-county, of Kakamega County. The BCH serves as a referral health</div>\n<div>\n facility offering both out-patient and in-patient services. Feeder health facilities include Shikunga, Shiraha, Shitswistwi,</div>\n<div>\n Lukohe, Iranda, Eshimkoko, Shisaba, Mabole, Manyala, Imanga in Butere and Khwisero, Mulwanda. Mundoli, Emusetsa in</div>\n<div>\n Khwisero Sub-County. These referrals account for the approximately 1425 patients seeking care for various medical</div>\n<div>\n conditions per month in the facility.</div>\n<div>\n  </div>\n<div>\n Butere is one of largest sub-counties in Kakamega county. It has a population of approximately 168,780 people, and area of</div>\n<div>\n approximately 210.6 Square Kilometers. It comprises of five Wards namely Marama West, Marama Central, Marenyo- Shianda,</div>\n<div>\n Marama North and Marama South. BCH is located north of the Equator, along Butere-Shiatsala Road off Sabatia town.</div>\n<div>\n  </div>\n<div>\n The population in the study area is primarily black African, and the languages spoken are Luhya, Kiswahili and English. The</div>\n<div>\n sub-county is largely rural with most residents within the area living in farmlands. The households in these areas are mostly</div>\n<div>\n semi-permanent dwellings with minimal modern provision of electricity, hardly any water and sewerage services connected to</div>\n<div>\n these areas. Water supply to the sub-county is supplied by the Kakamega County Water and Sanitation Company which has a</div>\n<div>\n minimal network of water supply to the sub-county. Being a rural area, the commercial activities are mainly subsistence</div>\n<div>\n farming and small-scale trading.</div>\n<div>\n  </div>\n<div>\n N/B</div>\n<div>\n this submission is for Dr Oyieko, Janet, other sites  have been submitted - Dr Lucas, Dr JAoko and Dr Onono.</div>\n<div>\n  </div>\n<div>\n other sites to be submitted are Dr. Kariuki, Dr Walter and Dr Sawe. as explained on the cover letter </div>\n<div>\n  </div>\n
      • other_details_explanation<p>\n The study will also be done in USA.</p>\n
      • other_details_regulatory_notapproved<p>\n Kenya, submitted in 09 Sep 2023</p>\n<p>\n Argentina - submitted  04 Oct  2023</p>\n<p>\n Brazil - submitted 23 Feb 2024</p>\n<p>\n Chile  - submitted01 Nov  2023- </p>\n<p>\n Colombia_submitted  08 Sep 2023 </p>\n<p>\n thailand _submitted  02 Oct 2023 </p>\n<p>\n Ghana_submitted  19 Sep 2023 </p>\n
      • other_details_regulatory_approved<p>\n South Africa - submitted 11 Aug 2023- approved 18 Oct 2023 - 9 sites </p>\n<p>\n  </p>\n
      • other_details_regulatory_rejected<p>\n none</p>\n
      • other_details_regulatory_halted<p>\n none</p>\n
      • estimated_duration4years. - each participant will be followed up for 24months.
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindNo
      • design_controlled_double_blindYes
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overNo
      • design_controlled_otherYes
      • design_controlled_specifyplacebo
      • design_controlled_comparatorplacebo
      • design_controlled_other_medicinalNo
      • design_controlled_placeboYes
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesYes
      • multiple_member_states19 Countries
      • number_of_sites7
      • multi_country_listChina India South Korea Thailand Japan Finland Germany Ghana Kenya South Africa Spain Turkey United Kingdom Brazil\nColombia Honduras Mexico Canada United States (inc. Puerto Rico)
      • data_monitoring_committeeYes
      • total_enrolment_per_sitecompetitive enrollment
      • total_participants_worldwide6300
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornYes
      • population_infant_and_toddlerYes
      • population_childrenNo
      • population_adolescentNo
      • population_above_18No
      • population_adultNo
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentYes
      • subjects_specify6 months to < 22 months of age. Pediatric Population
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameDr Fredrick
      • investigator1_middle_nameSawe
      • investigator1_family_nameSawe
      • investigator1_qualificationMedical doctor
      • investigator1_professional_addressMedical Research Institute/Walter Reed, Hospital Road, Kericho, Kenya
      • investigator1_telephone+254703247902
      • investigator1_emailFredrick.sawe@usamru-k.org
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        • id1045
        • application_id1386
        • given_nameDr. Janet
        • middle_nameNyawira
        • family_nameOyieko
        • qualificationMedical doctor
        • professional_addressButere Clinical Research Centre
        • telephone+254721996988
        • emailjanet.oyieko@usamru-k.org
        • created2024-03-06 07:56:09
        • modified2024-03-06 15:10:01
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        • site_nameKEMRI CCR – Butere Clinical Research Centre
        • physical_addressWithin Butere County Hospital
        • contact_detailsP.O. Box 40, 50101 Butere
        • contact_personDr. Janet Nyawira Oyieko
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          • created2012-06-15 10:26:29
          • modified2012-06-15 10:26:29
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        • sponsorSanofi Pasteur Inc.
        • sponsor_typeIndustry
        • contact_personSomnath Mangarule _Global Clinical Development Strategic Expert vaccines.
        • address1541,Avenue Marcel Mérieux 69280 Marcy l’Etoile, France
        • telephone_number+33 (0)6 76 97 20 84
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        • email_addressSomnath.mangarule@sanofi.com
        • created2024-03-06 07:56:09
        • modified2024-03-06 15:10:01
  • 4(array)
    • Application(array)
      • id1385
      • user_id667
      • trial_status_id1
      • abstract_of_study<p>\n African women face disproportionate risk from overlapping epidemics of HIV and bacterial sexually transmitted infections (STIs). HIV pre-exposure prophylaxis (PrEP) is emerging into a global context with unprecedented rates of curable STIs. Post-exposure prophylaxis using the antibiotic doxycycline has been proposed as a novel STI prevention strategy. The first study of doxycycline postexposure prophylaxis for cisgender women did not reduce incident STIs likely due to low use of doxycycline. The overarching goal is to assess acceptability and adherence to once-weekly doxycycline dosing to prevent STIs. We will conduct a pilot study of once-weekly doxycycline to prevent bacterial STIs among Kenyan cisgender women using PrEP for HIV prevention. Approximately 50 (up to 60) sexually active, cisgender women ages 18-30 years will be enrolled in this study and followed for six months. Participants will receive doxycycline once-weekly dose as directly observed therapy (DOT). All participants will complete STI testing (chlamydia, gonorrhea, and syphilis)at enrollment, month-three and month-six. Prior to initiating treatment and at exit visit, all participants will have samples collected for future microbiome and resistance testing. Hair samples will be collected at follow-up visits for future pharmacokinetic model development. The primary endpoint is percentage of completed weekly DOT doxycycline doses. Secondary endpoint is quarterly incident rate of <em>Chlamydia trachomatis</em> compared with quarterly incidence among participants assigned to standard of care in the dPEP Kenya Study.</p>\n
      • study_title<p align=\"center\">\n Weekly doxycycline DOT for STI prevention among cisgender women taking HIV PrEP in Kisumu, Kenya</p>\n
      • laymans_summary<p>\n We propose to conduct research on weekly antibiotic, specifically doxyclycline, taken under the observation of trained research staff, for prevention of bacterial sexually transmitted infections (STIs) among Kenyan women. The study population will include up to sixty Kenyan women between 18 and 30 years old who are already using a medication called pre-exposure prophylaxis (PrEP) for prevention of HIV. The study will be conducted at the KEMRI-RCTP clinic at Lumumba Sub-County Hospital in Kisumu County, Kenya. The primary objectives of the study are to assess the acceptability and continued use of weekly doxycycline when given under direct observation. We will also measure rates of STIs when taking weekly doxycycline prophylaxis among HIV-uninfected Kenyan women compared with data from a similar population of participants in a recently completed study (dPEP Kenya Study) in Kisumu, Kenya. Participants will be followed for six months. Participants will receive doxycycline once-weekly dose with assistance from study staff to be taken under direct observation, and participants will have STI (chlamydia, gonorrhea, and syphilis) testing and treatment at enrollment, at month-three, and at month-six. The primary outcome is continuation of antibiotic prophylaxis, or the percentage of completed weekly doxycycline doses. Secondary outcomes include quarterly new infections with the bacterial STI, <em>Chlamydia trachomatis</em>. Before starting study medicine and at the final visit, all participants will have samples collected for future testing of bacteria that live in the reproductive and gastrointestinal tract and resistance to antibiotics. Hair samples will be collected at follow-up visits for future study of the amount of doxycycline in hair with once a week use of doxycycline.</p>\n
      • short_titleDoxyDOT Study
      • protocol_noECCT/24/03/03
      • version_no1.0
      • date_of_protocol03-01-2024
      • study_drugDoxycycline Hyclate 100mg capsules
      • disease_conditionBacterial STIs (Chlamydia, gonorrhoea, syphilis)
      • 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_nameDoxycycline 100mg Hyclate
      • product_type_medical_device_name
      • comparatorNo
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      • comparator_registered
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      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressebukusi@kemri.org
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      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi1
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      • statistical_analysis_plan1
      • applicant_contractual_agreement1
      • declaration_applicantGreshon Rota
      • declaration_date107-03-2024
      • declaration_principal_investigatorElizabeth Bukusi
      • declaration_date207-03-2024
      • placebo_presentNo
      • study_objectives<h2>\n <strong>Primary Study Objectives:</strong></h2>\n<ol>\n <li>\n Assess the acceptability of once weekly doxycycline prophylaxis</li>\n <li>\n Assess persistence in once weekly doxycycline DOT</li>\n</ol>\n<h2>\n <strong>Secondary Study Objectives:</strong></h2>\n<ol>\n <li>\n Evaluate incidence rate of STIs in women given once-weekly doxycycline DOT</li>\n <li>\n Assess the safety and tolerability of once weekly doxycycline prophylaxis</li>\n <li>\n Collect samples for future doxycycline hair drug level pharmacokinetic drug testing, rectal swabs and endocervical swabs for resistance testing, and rectal and vaginal swabs for microbiome evaluation.</li>\n</ol>\n
      • principal_inclusion_criteria<ol>\n <li>\n Willing and able to give written informed consent</li>\n <li>\n Age 18-30 years</li>\n <li>\n Female sex at birth</li>\n <li>\n HIV-seronegative, according to national HIV testing algorithm</li>\n <li>\n Has a current prescription for PrEP, according to the national guidelines of Kenya</li>\n <li>\n Able and willing to adhere to DOT dosing schedules</li>\n</ol>\n
      • principal_exclusion_criteria<ol>\n <li>\n Pregnant</li>\n <li>\n Breastfeeding a child</li>\n <li>\n Allergy to tetracycline class</li>\n <li>\n Current medications which may impact doxycycline metabolism or that are contraindicated with doxycycline, as per the prescribing information. These include systemic retinoids, barbiturates, carbamazepine, phenytoin, and warfarin.</li>\n <li>\n Active, clinically significant medical or psychiatric conditions that would interfere with study participation, at the discretion of the site investigator or designee.</li>\n <li>\n Prior enrollment in The dPEP Kenya Study</li>\n</ol>\n
      • primary_end_points<p>\n Percentage of completed doses of weekly doxycycline DOT (directly observed therapy) measured at week 26 which is the study exit visit.</p>\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_controlledNo
      • site_capacity(null)
      • staff_numbers<p>\n <strong>The study site is:</strong></p>\n<p>\n KEMRI-RCTP</p>\n<p>\n KEMRI CIS Building</p>\n<p>\n Lumumba Sub-County Hospital</p>\n<p>\n Along Ondiek Highway</p>\n<p>\n P.O Box 614-40100</p>\n<p>\n Kisumu</p>\n<p>\n  </p>\n<p>\n The facility has</p>\n<ol>\n <li>\n Reception and waiting bay</li>\n <li>\n Six Clinic rooms</li>\n <li>\n Pharmacy</li>\n <li>\n Laboratory</li>\n <li>\n Data room</li>\n <li>\n Administration office</li>\n <li>\n Open Office</li>\n <li>\n Washrooms</li>\n</ol>\n<p>\n  </p>\n<p>\n <u><strong>Personnel</strong></u></p>\n<p>\n The site has 16 Staff dedicated to this study. These are as follows</p>\n<p>\n <strong>Prof. Elizabeth Bukusi, Principal Investigator</strong></p>\n<p>\n She is the KEMRI PI and will work in association with the Co-investigators in the overall implementation of the Project. She is responsible for overseeing the progress of the study and also the chief liaison with the local government and other regulatory bodies. </p>\n<p>\n <strong>Dr. Zachary Kwena, Social Scientist/Co-Investigator</strong></p>\n<p>\n The Social Scientist will  support all the qualitative aspects of the study and also is a co-investigator. This is in line with the requirement of the KEMRI IRB to ensure that any qualitative study engages a social scientist.</p>\n<p>\n <strong>Dr Felix Mogaka, Study Coordinator and study doctor</strong></p>\n<p>\n The Study Coordinator will be responsible for the smooth functioning of the project, coordinating communications with regulatory boards, staff and investigators, assisting investigators with implementation, planning and problem-solving on behalf of the PI to ensure project goals are met. Providing protocol guidance to staff, supervising and monitoring staff performance general day-to-day study administration.</p>\n<p>\n <strong>Two  Lab Technologists</strong></p>\n<p>\n The Lab Technologists will be  responsible for performing all the lab tests required for the participants,maintaining and charting of the temperature logs in the laboratory, archiving samples and ensuring proper storage is done,  and maintaining the Study documents in files and folders appropriately.  Monitors abnormal results for participants and communicates the same to the  clinician.</p>\n<p>\n <strong>Recruitment Lead </strong></p>\n<p>\n The Recruitment lead will responsible for the day-to –day activities of the Outreach Workers including sensitizing the community and assisting in public relations for the study. He/She will be responsible for the development and distribution of recruitment materials, supervise community Health workers as they conduct follow-up mainly through calls to study participants who fail to keep their scheduled appointments; and document follow up calls.</p>\n<p>\n <strong>Administrator</strong></p>\n<p>\n This administrator will be responsible for assisting in overall planning for the project in liaison with the Project coordinator, budget preparation, maintaining of proper audit trail for study funds and expenditures, generate monthly invoices, and other financial reports as required in the subcontract. He will also be responsible for the handling and accounting for the field impress given to the project.</p>\n<p>\n <strong>Clinician</strong></p>\n<p>\n The clinician will be responsible for authoring clinic and updating SOPs for the study, ensuring that all applicable clinic staff follows the SOPs. Recognize, monitor and report study adverse events, perform clinical assessment carry out medical examinations including gynecological exams and prescribe medication as required to the participants. </p>\n<p>\n <strong>Pharmaceutical Technologist</strong></p>\n<p>\n The pharmaceutical technologists will assist in dispensing drugs and provide adherence counseling. He/She will  also responsible for tracking the amount of study drug kits and documentation of the same</p>\n<p>\n <strong>Three Nurse Counselors</strong></p>\n<p>\n The Nurse Counselors will be responsible for assessing and caring for participants in the study. He/She will also provide HIV, pre/post counseling and testing, contraception counseling and reinforce adherence. He/She  will also collect blood for laboratory testing and administer questionnaires when needed.</p>\n<p>\n <strong>Two Field Research Assistants</strong></p>\n<p>\n The field research assistant will be responsible for recruiting of the participants to the study by use of various strategies such as fliers, health talks among others. He/She will also be responsible for participants follow up by ensuring they are reminded of their scheduled visits through calls or physical tracing.</p>\n<p>\n <strong>Dr. Greshon Rota, Pharmacist of Records</strong></p>\n<p>\n The Pharmacist of records will be responsible for representation of the Pharmacy and Poisons Board IRB. He will ensure that the study gets approval from PPB and gets renewal every year as per the regulations.</p>\n<p>\n  <strong>Data Manager</strong></p>\n<p>\n The Data Manager will assist in Quality Assurance, Quality Control of data and also be involved in data collection and management. He/She will also be instrumental in adopting several datasets for the study site including creating additional site-specific access data sets for internal monitoring and evaluation. Ensures confidentiality of participant’s information (Consent forms, name charts, CRFs) by keeping link-logs under double lock system.</p>\n<p>\n  </p>\n
      • other_details_explanation<p>\n The study seeks to get information on sexually transmitted infection prevention among Kenyan women.</p>\n
      • other_details_regulatory_notapproved<p>\n None</p>\n
      • other_details_regulatory_approved<p>\n None</p>\n
      • other_details_regulatory_rejected<p>\n None</p>\n
      • other_details_regulatory_halted<p>\n None</p>\n
      • estimated_duration1 year
      • 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_stateYes
      • location_of_areaKEMRI CMR RCTP
      • single_site_physical_addressLumumba Subcounty Hospital
      • single_site_contact_personDr Felix Mogaka
      • single_site_telephone+254723686156
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeNo
      • total_enrolment_per_site50 to 60 women
      • total_participants_worldwide50 to 60 women
      • 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_elderlyNo
      • gender_female1
      • gender_male0
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameElizabeth
      • investigator1_middle_nameAnne
      • investigator1_family_nameBukusi
      • investigator1_qualificationMBChB, M.Med (ObGyn), MPH, PhD, PGD (Research Ethics), MBE (Research Ethics)
      • investigator1_professional_addressKenya Medical Research Institute, Raila Odinga Way, Nairobi
      • investigator1_telephone+254733617503
      • investigator1_emailebukusi@kemri.go.ke
      • organisations_transferred_Yes
      • number_participants50 to 60 women
      • notification
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      • initial_date_submitted07-03-2024
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      • modified2024-09-09 15:17:15
      • created2024-03-06 00:02:53
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        • professional_addressKenya Medical Research Institute, Raila Odinga Way, Nairobi
        • telephone+254733617503
        • emailebukusi@kemri.go.ke
        • created2024-03-06 00:19:32
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        • created2024-03-06 00:19:32
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        • telephone_number+1 206-543-2100
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        • created2024-03-06 00:19:32
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      • 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