Study of Oral Weekly Lepetegravir (Formerly GS-1720) and Lenacapavir Pacfosacil (Formerly GS-4182) Versus Biktarvy in People With HIV-1 Who Are Virologically Suppressed
Public ClinicalTrials.gov record NCT06544733. 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
An Operationally Seamless Phase 2/3, Randomized, Active-Controlled Study Evaluating the Safety and Efficacy of an Oral Weekly Regimen of GS-1720 in Combination With GS-4182 Versus Biktarvy in Virologically Suppressed People With HIV-1
Study identification
- NCT ID
- NCT06544733
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Lead sponsor
- Gilead Sciences
- Industry
- Enrollment
- 675 participants
Conditions and interventions
Conditions
Interventions
- Bictegravir/emtricitabine/tenofovir alafenamide Drug
- Lenacapavir pacfosacil Drug
- Lepetegravir Drug
- Lepetegravir/Lenacapavir pacfosacil FDC Drug
- Placebo to Match BVY Drug
- Placebo to Match GS1720/GS-4182 FDC Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Not listed
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 19, 2024
- Primary completion
- Dec 31, 2027
- Completion
- May 31, 2029
- Last update posted
- Apr 16, 2026
2024 – 2029
United States locations
- U.S. sites
- 35
- U.S. states
- 13
- U.S. cities
- 33
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UAB 1917 Research Clinic | Birmingham | Alabama | 35294 | — |
| Pacific Oaks Medical Group | Beverly Hills | California | 90211 | — |
| Ruane Clinical Research Group | Los Angeles | California | 90036 | — |
| Mills Clinical Research | Los Angeles | California | 90069 | — |
| BIOS Clinical Research | Palm Springs | California | 92262 | — |
| UCSF Division of HIV, Infectious Diseases & Global Medicine | San Francisco | California | 94110 | — |
| Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center | Torrance | California | 90502 | — |
| Georgetown University Medical Center | Washington D.C. | District of Columbia | 20007 | — |
| Midland Florida Clinical Research Center, LLC | DeLand | Florida | 32720 | — |
| CAN Community Health | Fort Lauderdale | Florida | 33316 | — |
| Midway and Immunology Research Center | Ft. Pierce | Florida | 34982 | — |
| AIDS Healthcare Foundation - The Kinder Medical Group | Miami | Florida | 33133 | — |
| Floridian Clinical Research | Miami Lakes | Florida | 33016 | — |
| Orlando Immunology Center | Orlando | Florida | 32803 | — |
| CAN Community Health | Sarasota | Florida | 34237 | — |
| Triple O Research Institute, P.A. | West Palm Beach | Florida | 33407 | — |
| Metro Infectious Disease Consultants, P.L.L.C. | Decatur | Georgia | 30033 | — |
| Mercer University, Department of Internal Medicine | Macon | Georgia | 31201 | — |
| Chatham County Health Department | Savannah | Georgia | 31401 | — |
| Be Well Medical Center | Berkley | Michigan | 48072 | — |
| KC CARE Health Center | Kansas City | Missouri | 64111 | — |
| Saint Michael's Medical Center | Newark | New Jersey | 07102 | — |
| AXCES Research Group, LLC | Santa Fe | New Mexico | 87505 | — |
| NewYork-Presbyterian Queens | Flushing | New York | 11355 | — |
| NYU Langone Health Vaccine Center | New York | New York | 10016 | — |
| Rosedale Health and Wellness | Huntersville | North Carolina | 28078 | — |
| Central Texas Clinical Research | Austin | Texas | 78705 | — |
| St Hope Foundation, Inc. | Bellaire | Texas | 77401 | — |
| Prism Health North Texas, Oak Cliff Health Center | Dallas | Texas | 75215 | — |
| 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 | — |
| DCOL Center for Clinical Research | Longview | Texas | 75605 | — |
| Peter Shalit, MD | Seattle | Washington | 98104 | — |
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 4 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06544733, 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 Apr 16, 2026 · Synced Apr 22, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06544733 live on ClinicalTrials.gov.