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

NCT02016924 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 133

Last updated 2026-04-21

No results posted yet for this study

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

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

Sponsors & Collaborators

Principal Investigators

  • Gilead Study Director · Gilead Sciences

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
4 Weeks
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-16
Primary Completion
2025-06-13
Completion
2027-03-31
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • South Africa
  • Thailand
  • Uganda
  • United Kingdom
  • Zimbabwe

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02016924 on ClinicalTrials.gov