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NCT06333808 · ClinicalTrials.gov registry record · Phase 3
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy
A Phase 3 study of HIV-1-infection, sponsored by Gilead Sciences.
- Active
- Registry status
- Phase 3
- Development phase
- 577
- Enrollment target
- 20
- Study locations
NCT06333808 is a Phase 3 study of HIV-1-infection that is active but no longer recruiting, run by Gilead Sciences. The registered enrollment target is 577 participants, above the 343-participant average among 71 other HIV-1-infection trials with a reported enrollment target (68% higher). The trial reports 20 study locations across 5 states.
The verdict
NCT06333808, a Phase 3 study of HIV-1-infection, is active but no longer recruiting, sponsored by Gilead Sciences.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 577 participants
- Enrollment target
- 20
- Study locations
Study Summary
The goal of this clinical study is to learn more about the effects of switching to the study drugs, bictegravir (BIC)/lenacapavir (LEN), fixed-dose combination (FDC) versus current therapy bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) FDC in people living with HIV-1 (PWH). The primary objective of this study is to learn how effective it is to switch to BIC/LEN FDC tablets versus continuing on B/F/TAF FDC tablets in virologically suppressed PWH.
Conditions Studied
Interventions
- DRUG Lenacapavir
- DRUG B/F/TAF
- DRUG Bictegravir
- DRUG Placebo to match B/F/TAF
- DRUG Placebo to match BIC/LEN
Study Locations (20)
Florida
- Midland Florida Infectious Diseases Specialists, PL - Orange City - DeLand
- Therafirst Medical Center - Fort Lauderdale
- CAN Community Health - Fort Lauderdale
- Midway Immunology and Research Center - Ft. Pierce
- AIDS Healthcare Foundation - The Kinder Medical Group - Miami
- Schiff Center for liver Diseases/University of Miami - Miami
- Floridian Clinical Research - Miami Lakes
- Orlando Immunology Center - Orlando
- Bliss Healthcare - Orlando
California
- Be Well Medical Center - Berkeley
- Pacific Oaks Medical Group - Beverly Hills
- Ruane Clinical Research Group Inc. - Los Angeles
- Alta Bates Summit Medical Center, Summit Campus, East Bay Advanced Care - Oakland
- BIOS Clinical Research - Palm Springs
- UCSD Anti Viral Research Centre (AVRC) - San Diego
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center - Torrance
- Mills Clinical Research - West Hollywood
Arizona
- Pueblo Family Physicians - Phoenix
Colorado
- Public Health Institute at Denver Health - Denver
Connecticut
- Yale University School of Medicine (study visits) - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 577 participants |
| Start Date | 2024-03-25 |
| Est. Completion | 2029-12 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06333808
The ClinicalTrials.gov registry entry for NCT06333808 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 577 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 343-participant average among 71 other HIV-1-infection trials with a reported enrollment target (68% higher). The listed sponsor is Gilead Sciences, which has 504 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with HIV-1-infection appearing as the primary indexed condition, and to 5 interventions - of which Lenacapavir is the first listed.
NCT06333808 reports 20 study locations spanning 5 distinct geographic areas - top geographies include Florida, California, Arizona.
Frequently Asked Questions
What is clinical trial NCT06333808 about?
NCT06333808 is a clinical study titled "Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy". The goal of this clinical study is to learn more about the effects of switching to the study drugs, bictegravir (BIC)/lenacapavir (LEN), fixed-dose combination (FDC) versus current therapy bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) FDC in people living with HIV-1 (PWH). The primary o...
What is the current status of trial NCT06333808?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 577 participants. The study started on 2024-03-25. Estimated completion is 2029-12.
What conditions does trial NCT06333808 study?
This clinical trial studies the following conditions: HIV-1-infection.
What interventions are being tested in trial NCT06333808?
The interventions under investigation include: Lenacapavir (DRUG), B/F/TAF (DRUG), Bictegravir (DRUG), Placebo to match B/F/TAF (DRUG), Placebo to match BIC/LEN (DRUG).
Who is sponsoring clinical trial NCT06333808?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06333808 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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