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NCT02607930 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate the Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Abacavir/Dolutegravir/Lamivudine in Human Immunodeficiency Virus-1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults
A Phase 3 study of HIV-1-infection, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 3
- Development phase
- 631
- Enrollment target
- 20
- Study locations
NCT02607930: Completed Phase 3 study of HIV-1-infection, sponsored by Gilead Sciences.
NCT02607930 is a Phase 3 study of HIV-1-infection that has completed, run by Gilead Sciences. The registered enrollment target is 631 participants, above the 343-participant average among 71 other HIV-1-infection trials with a reported enrollment target (84% higher). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02607930, a Phase 3 study of HIV-1-infection, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 631 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary objective of this study is to evaluate the efficacy of a fixed dose combination (FDC) containing bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus a FDC containing abacavir/dolutegravir/lamivudine (ABC/DTG/3TC) in HIV-1 infected, antiretroviral treatment naive-adults.
Primary Outcome
The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Conditions Studied
Interventions
- DRUG B/F/TAF
- DRUG ABC/DTG/3TC
- DRUG ABC/DTG/3TC Placebo
- DRUG B/F/TAF Placebo
Study Locations (20)
California
- Kaiser Permanente Medical Center - Los Angeles
- Ruane Clinical Research Group, Inc. - Los Angeles
- Anthony Martin Mills MD A Medical Corporation, DBA Mills Clinical Research - Los Angeles
- Alameda Health System- Highland Hospital - Oakland
- University of California Davis - Sacramento
- Kaiser Permanente Medical Group - Sacramento
- La Playa Medical Group - San Diego
- Kaiser Permanente - San Francisco
- Kaiser Permanente - San Leandro
- The Lundquist Institute for BioMedical Innovation at Harbor-UCLA Medical Center - Torrance
District of Columbia
- Whitman-Walker Institute - Washington D.C.
- Providence Hospital - DC - Washington D.C.
- Capital Medical Associates - Washington D.C.
- Medical Faculty Associates - Washington D.C.
Arizona
- Spectrum Medical Group - Phoenix
- Pueblo Family Physicians - Phoenix
Florida
- Therafirst Medical Center - Fort Lauderdale
- Gary J. Richmond, M.D., P.A. - Fort Lauderdale
Alabama
- University of Alabama at Birmingham - Birmingham
Colorado
- Apex Research - Denver
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 631 participants |
| Start Date | 2015-11-13 |
| Est. Completion | 2021-07-02 |
| Phase | Phase 3 |
What the finished NCT02607930 record still lists
NCT02607930 is an interventional study that assigns participants to a tested intervention. The registered 631 participants enrollment target is mid-sized for trials with a published cap, above the 343-participant average among 71 other HIV-1-infection trials with a reported enrollment target (84% higher).
The record links to 1 condition, with HIV-1-infection appearing as the primary indexed condition, and to 4 interventions - of which B/F/TAF is the first listed.
NCT02607930 names 20 study sites across 6 states, led by California, District of Columbia, Arizona.
Frequently Asked Questions
What is clinical trial NCT02607930 about?
NCT02607930 is a clinical study titled "Study to Evaluate the Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Abacavir/Dolutegravir/Lamivudine in Human Immunodeficiency Virus-1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults". The primary objective of this study is to evaluate the efficacy of a fixed dose combination (FDC) containing bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus a FDC containing abacavir/dolutegravir/lamivudine (ABC/DTG/3TC) in HIV-1 infected, antiretroviral treatment naive-adults.
What is the current status of trial NCT02607930?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 631 participants. The study started on 2015-11-13. Estimated completion is 2021-07-02.
What conditions does trial NCT02607930 study?
This clinical trial studies the following conditions: HIV-1-infection.
What interventions are being tested in trial NCT02607930?
The interventions under investigation include: B/F/TAF (DRUG), ABC/DTG/3TC (DRUG), ABC/DTG/3TC Placebo (DRUG), B/F/TAF Placebo (DRUG).
Who is sponsoring clinical trial NCT02607930?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02607930 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for HIV-1-infection
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02607930's enrollment target sits among peer trials
631 7th of 71 higher than 65 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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