NCT02016924

Study of Cobicistat-Boosted Atazanavir (ATV/co), Cobicistat-Boosted Darunavir (DRV/co) and Emtricitabine/Tenofovir Alafenamide (F/TAF) in Children With HIV

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

• Status: Active Not Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 133 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 4 Weeks – 17 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical study is to learn more about the safety and dosing of study drugs, cobicistat-boosted Atazanavir (ATV/co), cobicistat-boosted darunavir (DRV/co) and emtricitabine/tenofovir alafenamide (F/TAF), in children (age ≥ 4 weeks to \< 18 years) with HIV.

Conditions

• Acquired Immune Deficiency Syndrome (AIDS)
• HIV Infections

Interventions

Type	Name	Description
DRUG	ATV	Capsules administered once daily according to dosing recommendations per product monograph
DRUG	DRV	Tablets administered once daily according to dosing recommendations per product monograph
DRUG	Cobicistat	Tablets administered orally once daily with food
DRUG	BR	Background Regimen (BR) include Food and Drug Administration (FDA)-approved nucleos(t)ide reverse transcriptase inhibitors (NRTIs) including zidovudine (ZDV), stavudine (d4T), didanosine (ddI), abacavir (ABC), tenofovir disoproxil fumarate (TDF), tenofovir alafenamide (TAF), lamivudine (3TC), and emtricitabine (FTC).
DRUG	F/TAF	Tablets administered orally once daily
DRUG	LPV/r	Solution administered orally
DRUG	Third Unboosted Drug	ATV (administered orally), DRV (administered orally), and LPV/r (administered orally) would be general list but unspecified for sites.
DRUG	Cobicistat TOS	Tablets for oral suspension
DRUG	F/TAF TOS	Tablets for oral suspension

Timeline

• Start date: 2014-01-16
• Primary completion: 2025-06-13
• Completion: 2027-03-01
• First posted: 2013-12-20
• Last updated: 2026-03-20

Locations

23 sites across 7 countries: United States, Argentina, South Africa, Thailand, Uganda, United Kingdom, Zimbabwe

Regulatory

• FDA-regulated drug study