Study of Bictegravir/Emtricitabine/Tenofovir Alafenamide Fixed Dose Combination in Adolescents and Children With Human Immunodeficiency Virus-1
Public ClinicalTrials.gov record NCT02881320. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2/3, Open-Label Study of the Pharmacokinetics, Safety, and Antiviral Activity of the GS-9883/Emtricitabine/Tenofovir Alafenamide (GS-9883/F/TAF) Fixed Dose Combination (FDC) in HIV-1 Infected Adolescents and Children
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The goals of this clinical study are to learn how Bictegravir/Emtricitabine/Tenofovir Alafenamide fixed dose combination (FDC) interacts with the body, confirm the dose, and also to learn more about the safety and tolerability of Bictegravir/Emtricitabine/Tenofovir Alafenamide FDC in adolescents and children with HIV-1.
Study identification
- NCT ID
- NCT02881320
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 177 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 1 Month to 17 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 20, 2016
- Primary completion
- Mar 23, 2025
- Completion
- Oct 31, 2026
- Last update posted
- Mar 23, 2026
2016 – 2026
United States locations
- U.S. sites
- 10
- U.S. states
- 8
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Children's National Health System | Washington D.C. | District of Columbia | 20010 | — |
| Midway Immunology and Research Center | Ft. Pierce | Florida | 34982 | — |
| University of Florida Health | Gainesville | Florida | 32209 | — |
| USF Clinic at Children's Medical Services (study visits and drug storage) | Tampa | Florida | 33606 | — |
| Grady Health System Ponce Center Family and Youth Clinic | Atlanta | Georgia | 30322 | — |
| Wayne Pediatric Clinic | Detroit | Michigan | 48201 | — |
| Bellevue Hospital | New York | New York | 10016 | — |
| Duke Children's Health Center, Pediatric Infectious Diseases | Durham | North Carolina | 27710 | — |
| St. Christopher's Hospital for Children/Section of Immunology | Philadelphia | Pennsylvania | 19134 | — |
| St. Jude Children's Research Hospital | Memphis | Tennessee | 38105 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 15 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02881320, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 23, 2026 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02881320 live on ClinicalTrials.gov.