Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy
NCT06333808 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 577 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gilead Sciences, which has 190 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06333808 reports 20 study locations spanning 5 distinct geographic areas — top geographies include Florida, California, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06333808?
This trial is sponsored by Gilead Sciences, which has 190 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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