Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy
Public ClinicalTrials.gov record NCT06333808. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Phase 3 Double-blind Multicenter Randomized Active-Controlled Study to Evaluate the Safety and Efficacy of Bictegravir/Lenacapavir Versus Biktarvy® (Bictegravir/Emtricitabine/Tenofovir Alafenamide) in Virologically Suppressed People With HIV-1
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06333808
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 577 participants
Conditions and interventions
Conditions
Interventions
- Bictegravir Drug
- Lenacapavir Drug
- B/F/TAF Drug
- Placebo to match B/F/TAF Drug
- Placebo to match BIC/LEN Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 25, 2024 (Actual)
- Primary completion
- Oct 27, 2025 (Actual)
- Completion
- Dec 2029 (Estimated)
- Last update posted
- Jun 15, 2026
2024 – 2029
United States locations
- U.S. sites
- 51
- U.S. states
- 19
- U.S. cities
- 46
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Pueblo Family Physicians | Phoenix | Arizona | 85015 | — |
| Be Well Medical Center | Berkeley | California | 48072 | — |
| Pacific Oaks Medical Group | Beverly Hills | California | 90211 | — |
| Ruane Clinical Research Group Inc. | Los Angeles | California | 90036 | — |
| Alta Bates Summit Medical Center, Summit Campus, East Bay Advanced Care | Oakland | California | 94609 | — |
| BIOS Clinical Research | Palm Springs | California | 92262 | — |
| UCSD Anti Viral Research Centre (AVRC) | San Diego | California | 92103 | — |
| Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center | Torrance | California | 90502 | — |
| Mills Clinical Research | West Hollywood | California | 90046 | — |
| Public Health Institute at Denver Health | Denver | Colorado | 80204 | — |
| Yale University School of Medicine (study visits) | New Haven | Connecticut | 06510 | — |
| Midland Florida Infectious Diseases Specialists, PL - Orange City | DeLand | Florida | 32720 | — |
| Therafirst Medical Center | Fort Lauderdale | Florida | 33308 | — |
| CAN Community Health | Fort Lauderdale | Florida | 33316 | — |
| Midway Immunology and Research Center | Ft. Pierce | Florida | 34982 | — |
| AIDS Healthcare Foundation - The Kinder Medical Group | Miami | Florida | 33133 | — |
| Schiff Center for liver Diseases/University of Miami | Miami | Florida | 33136 | — |
| Floridian Clinical Research | Miami Lakes | Florida | 33016 | — |
| Orlando Immunology Center | Orlando | Florida | 32803 | — |
| Bliss Healthcare | Orlando | Florida | 32806 | — |
| AHF Pensacola | Pensacola | Florida | 32503 | — |
| CAN community Health | Sarasota | Florida | 34237 | — |
| Triple O Research Institute, P.A. | West Palm Beach | Florida | 33407 | — |
| Infectious Disease Specialists of Atlanta | Decatur | Georgia | 30033 | — |
| Mercer University, Department of Internal Medicine | Macon | Georgia | 31201 | — |
| Claudia T Martorell MD LLC dba The Research Institute | Springfield | Massachusetts | 01105 | — |
| Henry Ford Health | Detroit | Michigan | 48202 | — |
| KC Care health Center | Kansas City | Missouri | 64111 | — |
| Southampton Community Healthcare, Inc. | St Louis | Missouri | 63139 | — |
| ID Care, LLC | Hillsborough | New Jersey | 08844 | — |
| Saint Michael's Medical Center | Newark | New Jersey | 07102 | — |
| New Jersey Medical School - Clinical Research Center | Newark | New Jersey | 07103 | — |
| South Jersey Infectious Disease | Somers Point | New Jersey | 08244 | — |
| AXCES Research Group, LLC | Santa Fe | New Mexico | 87505 | — |
| New York-Presbyterian Queens | Flushing | New York | 11355 | — |
| Montefiore Medical Center | The Bronx | New York | 10467 | — |
| The Brody School of Medicine at East Carolina University , ECU Adult Specialty Care | Greenville | North Carolina | 27858 | — |
| Rosedale Health and Wellness | Huntersville | North Carolina | 28078 | — |
| Philadelphia FIGHT Community Health Centers | Philadelphia | Pennsylvania | 19107 | — |
| Medical University of South Carolina (MUSC) Research Nexus | Charleston | South Carolina | 29425 | — |
| Central Texas Clinical Research | Austin | Texas | 78705 | — |
| St Hope Foundation, Inc. | Bellaire | Texas | 77401 | — |
| AIDS Arms, Inc. DBA Prism Health North Texas | Dallas | Texas | 75208 | — |
| North Texas Infectious Diseases Consultants, PA | Dallas | Texas | 75246 | — |
| AXCES Research Group, LLC | El Paso | Texas | 79902 | — |
| Texas Centers for Infectious Disease Associates | Fort Worth | Texas | 76104 | — |
| The Crofoot research Center, INC. | Houston | Texas | 77098 | — |
| AXCES Research Group, LLC | Salt Lake City | Utah | 84102 | — |
| Clinical Alliance For Research & Education - Infectious Diseases. LLC (CARE-ID) | Annandale | Virginia | 22003 | — |
| Peter Shalit MD | Seattle | Washington | 98104 | — |
| Community Health care | Tacoma | Washington | 98405 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 53 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06333808, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 15, 2026 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06333808 live on ClinicalTrials.gov.