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NCT02881320 · ClinicalTrials.gov registry record · Phase 2
Study of Bictegravir/Emtricitabine/Tenofovir Alafenamide Fixed Dose Combination in Adolescents and Children With Human Immunodeficiency Virus-1
A Phase 2 study of HIV-1-infection, sponsored by Gilead Sciences.
- Active
- Registry status
- Phase 2
- Development phase
- 177
- Enrollment target
- 20
- Study locations
NCT02881320: Active Phase 2 study of HIV-1-infection, sponsored by Gilead Sciences.
NCT02881320 is a Phase 2 study of HIV-1-infection that is active but no longer recruiting, run by Gilead Sciences. The registered enrollment target is 177 participants, below the 349-participant average among 71 other HIV-1-infection trials with a reported enrollment target (49% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02881320, a Phase 2 study of HIV-1-infection, is active but no longer recruiting, sponsored by Gilead Sciences.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 177 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval). Cohorts 1 \& 2 Part A will participate in an Intensive PK Evaluation at Week 2 or Week 4. Samples will be collected at 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, and 24 hours post-dose. Cohort 3 Part A will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose. Cohort 4 Gr
Conditions Studied
Interventions
- DRUG B/F/TAF (Adult Strength)
- DRUG B/F/TAF (Low Dose)
- DRUG B/F/TAF (TOS)
Study Locations (20)
Other
- Department of Paediatrics and Child Health - Bloemfontein
- Be Part Ypluntu Centre - Cape Town
- FAMCRU, Ward J8 - CapeTown
- Dr. J Fourie Medical Centre - Dundee
- Enhancing Care Foundation, Durban International Clinical Research Site - Durban
- Wits RHI Shandukani Research Centre, Wits Reproductive Health & HIV Institute - Johannesburg
- Empilweni Service and Research Unit (ESRU) - Johannesburg
- VX Pharma(Pty) Ltd - Pretoria
- Perinatal HIV Research Unit - Soweto
- The HIV Netherlands Australia Thailand Research Collaboration - Bangkok
Florida
- Midway Immunology and Research Center - Ft. Pierce
- University of Florida Health - Gainesville
- USF Clinic at Children's Medical Services (study visits and drug storage) - Tampa
District of Columbia
- Children's National Health System - Washington D.C.
Georgia
- Grady Health System Ponce Center Family and Youth Clinic - Atlanta
Michigan
- Wayne Pediatric Clinic - Detroit
New York
- Bellevue Hospital - New York
North Carolina
- Duke Children's Health Center, Pediatric Infectious Diseases - Durham
Pennsylvania
- St. Christopher's Hospital for Children/Section of Immunology - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 177 participants |
| Start Date | 2016-09-21 |
| Est. Completion | 2026-11 |
| Phase | Phase 2 |
What the registry record for NCT02881320 still lists
NCT02881320 is an interventional study that assigns participants to a tested intervention. The registered 177 participants enrollment target is mid-sized for trials with a published cap, below the 349-participant average among 71 other HIV-1-infection trials with a reported enrollment target (49% lower).
The record links to 1 condition, with HIV-1-infection appearing as the primary indexed condition, and to 3 interventions - of which B/F/TAF (Adult Strength) is the first listed.
NCT02881320 names 20 study sites across 9 states, led by Other, Florida, District of Columbia.
Frequently Asked Questions
What is clinical trial NCT02881320 about?
NCT02881320 is a clinical study titled "Study of Bictegravir/Emtricitabine/Tenofovir Alafenamide Fixed Dose Combination in Adolescents and Children With Human Immunodeficiency Virus-1". 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...
What is the current status of trial NCT02881320?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 177 participants. The study started on 2016-09-21. Estimated completion is 2026-11.
What conditions does trial NCT02881320 study?
This clinical trial studies the following conditions: HIV-1-infection.
What interventions are being tested in trial NCT02881320?
The interventions under investigation include: B/F/TAF (Adult Strength) (DRUG), B/F/TAF (Low Dose) (DRUG), B/F/TAF (TOS) (DRUG).
Who is sponsoring clinical trial NCT02881320?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02881320 being conducted?
This trial has 20 study locations across District of Columbia, Florida, Georgia, Michigan, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02881320's enrollment target sits among peer trials
177 20th of 71 higher than 52 of 71 other HIV-1-infection trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV-1-infection trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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