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
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 experimental drugs lepetegravir and lenacapavir pacfosacil; to compare the combination of lepetegravir and lenacapavir pacfosacil with the current standard-of-care treatment bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF, BVY), to see if the combination of lepetegravir and lenacapavir pacfosacil is safe and if it works for treating human immunodeficiency virus type 1 (HIV-1) infection. This study has two phases: Phase 2 and Phase 3. The primary objectives of this study are: Phase 2: To evaluate the efficacy of switching to oral weekly lepetegravir in combination with lenacapavir pacfosacil versus continuing BVY in virologically suppressed people with HIV-1 (PWH) at Week 24. Phase 3: To evaluate the efficacy of switching to oral weekly lepetegravir /lenacapavir pacfosacil Fixed-dose combination (FDC) tablet regimen versus continuing BVY in virologically suppressed PWH at Week 48.
Study identification
- NCT ID
- NCT06544733
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 675 participants
Conditions and interventions
Conditions
Interventions
- Lepetegravir Drug
- Lenacapavir pacfosacil Drug
- Placebo to Match BVY Drug
- Bictegravir/emtricitabine/tenofovir alafenamide Drug
- Lepetegravir/Lenacapavir pacfosacil FDC Drug
- Placebo to Match GS1720/GS-4182 FDC 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
- Aug 20, 2024 (Actual)
- Primary completion
- Jan 2028 (Estimated)
- Completion
- Jun 2029 (Estimated)
- Last update posted
- Apr 17, 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 17, 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 NCT06544733 live on ClinicalTrials.gov.