Africa Medical and Behavioral Sciences Organization
COBI is a Phase 2/3, multicenter, open-label, multicohort clinical trial to evaluate the pharmacokinetics, safety, tolerability, and efficacy of cobicistat (COBI)-boosted antiretroviral regimens and emtricitabine/tenofovir alafenamide (F/TAF) in HIV-1 infected paediatric participants.
The study seeks to establish appropriate weight-based dosing while maintaining virologic suppression and ensuring long-term treatment safety across different paediatric age and weight groups. The study also assesses treatment adherence, acceptability, and key clinical outcomes.
To evaluate the steady-state pharmacokinetics (PK) of cobicistat-boosted atazanavir (ATV/co) and confirm the appropriate dose in eligible Cohort 4 participants.
To evaluate the steady-state PK of emtricitabine/tenofovir alafenamide (F/TAF) and confirm appropriate weight-based dosing in Cohorts 4 and 5.
To assess the safety and tolerability of the study regimens through 24 weeks in paediatric participants. Secondary Objectives
To evaluate the virologic efficacy of F/TAF- containing regimens through 24 and 48 weeks, including combinations with ATV/co, DRV/co, LPV/r (Cohort 4), or an unboosted third antiretroviral agent (Cohort 5)
To assess the long-term safety, tolerability, and efficacy of the study regimens through 48 weeks
Evaluate the steady-state PK of F/TAF tablet for oral suspension (TOS) in eligible participants
Evaluate the steady-state PK of lopinavir (LPV) and ritonavir (RTV) in participants receiving LPV/r-containing regimens
Protocol Title
A Phase 2/3, Multicenter, Open-label, Multicohort Study Evaluating Pharmacokinetics (PK), Safety, and Efficacy of Cobicistat-boosted Atazanavir (ATV/co) or Cobicistat-boosted Darunavir (DRV/co) and Emtricitabine/Tenofovir Alafenamide (F/TAF) in HIV-1 Infected, Virologically Suppressed Pediatric Participants
Study Site
Masaka Site
Dr. Nakigozi Getrude
Board Member
Dr. Nalugoda Fred
Board Member
Dr. Noah Kiwanuka
Collaborator
Gilead Sciences, Inc
Contact our research team to learn about eligibility and how to get involved.
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