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ACTIVE NOT RECRUITING Phase 2

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

NCT02016924 · View on ClinicalTrials.gov ↗

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.

Interventions

  • DRUG BR
  • DRUG ATV
  • DRUG DRV
  • DRUG Cobicistat
  • DRUG F/TAF

Study Locations (20)

Other

  • Hospital General de Agudos Cosme Argerich — Buenos Aires
  • Helios Salud — Buenos Aires
  • University of the Free State — Bloemfontein
  • University of Stellenbosch — Cape Town
  • King Edward VIII Hospital — Durban
  • Rahima Clinical Trials, a Division of Wits Health Consortium (Pty) Ltd — Johannesburg
  • The Aurum Institute: Pretoria Clinical Research Centre — Pretoria
  • Perinatal HIV Research Unit — Soweto
  • HIV-NAT — Bangkok
  • Siriraj Hospital — Bangkok
  • Srinagarind Hospital — Khon Kaen
  • MU-JHU Research Collaboration/MU-JHU Care Ltd — Kampala
  • SICRA-TASO Mulago National Referral Hospital — Kampala

California

  • Pediatric Infectious Disease Associates — Long Beach
  • Peter Morton Medical Building — Los Angeles

Colorado

  • University of Colorado Denver — Aurora

District of Columbia

  • The George Washington University — Washington D.C.

Florida

  • University of South Florida — Tampa

Tennessee

  • St. Jude Children's Research Hospital — Memphis

Texas

  • University of Texas Health Science Center of Houston — Houston

Trial Details

FieldValue
Enrollment Target 133 participants
Start Date 2014-01-16
Est. Completion 2027-03
Phase Phase 2

Sponsor

Gilead Sciences

190 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02016924

The ClinicalTrials.gov registry entry for NCT02016924 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 133 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gilead Sciences, which has 190 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with HIV Infections appearing as the primary indexed condition, and to 5 interventions — of which BR is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02016924 reports 20 study locations spanning 7 distinct geographic areas — top geographies include Other, California, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT02016924 about?

NCT02016924 is a clinical study titled "Study of Cobicistat-Boosted Atazanavir (ATV/co), Cobicistat-Boosted Darunavir (DRV/co) and Emtricitabine/Tenofovir Alafenamide (F/TAF) in Children With HIV". 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.

What is the current status of trial NCT02016924?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 133 participants. The study started on 2014-01-16. Estimated completion is 2027-03.

What conditions does trial NCT02016924 study?

This clinical trial studies the following conditions: HIV Infections, Acquired Immune Deficiency Syndrome (AIDS). These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02016924?

The interventions under investigation include: BR (DRUG), ATV (DRUG), DRV (DRUG), Cobicistat (DRUG), F/TAF (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02016924?

This trial is sponsored by Gilead Sciences, which has 190 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT02016924 being conducted?

This trial has 20 study locations across California, Colorado, District of Columbia, Florida, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial