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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: Active Phase 3 study of HIV-1-infection, sponsored by Gilead Sciences.
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. According to ClinicalTrials.gov, the official US trial registry.
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 |
What the registry record for NCT06333808 still lists
NCT06333808 is an interventional study that assigns participants to a tested intervention. The registered 577 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 (68% higher).
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 names 20 study sites across 5 states, led by 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.
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 NCT06333808's enrollment target sits among peer trials
577 11th of 71 higher than 61 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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A Switch to Doravirine/Islatravir (DOR/ISL) in Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Who Are Virologically Suppressed on Antiretroviral Therapy (ART) (MK-8591A-051)
ACTIVE NOT RECRUITING · Phase 3
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Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Standard of Care in Virologically Suppressed People With HIV-1
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