Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed People With HIV-1
Public ClinicalTrials.gov record NCT06630286. 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
A Phase 3, Randomized, Double-blind, Active-controlled Study to Evaluate a Switch to an Oral Weekly Islatravir/Lenacapavir Regimen in People With HIV-1 Who Are Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The goal of this clinical study is to learn about the safety and efficacy of switching to once weekly tablet of islatravir/lenacapavir (ISL/LEN) regimen versus continuing standard treatment of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in people with human immunodeficiency virus (PWH) who are virologically suppressed (HIV-1 RNA levels \< 50 copies/mL) on B/F/TAF for ≥ 6 months prior to screening. The primary objective is to evaluate the efficacy of switching to oral weekly ISL/LEN tablet regimen versus continuing B/F/TAF in virologically suppressed PWH at Week 48.
Study identification
- NCT ID
- NCT06630286
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 609 participants
Conditions and interventions
Conditions
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
- Oct 9, 2024 (Actual)
- Primary completion
- Apr 17, 2026 (Actual)
- Completion
- Aug 2030 (Estimated)
- Last update posted
- Apr 30, 2026
2024 – 2030
United States locations
- U.S. sites
- 60
- U.S. states
- 24
- U.S. cities
- 53
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | — |
| Pueblo Family Physicians | Phoenix | Arizona | 85015 | — |
| Kaiser Permanente Southern California | Los Angeles | California | 90027 | — |
| Ruane Clinical Research Group, Inc | Los Angeles | California | 90036 | — |
| Mills Clinical Research | Los Angeles | California | 90069 | — |
| BIOS Clinical Research | Palm Springs | California | 92262 | — |
| Optimus Medical Group | San Francisco | California | 94102 | — |
| Vivent Health | Denver | Colorado | 80246 | — |
| University of Colorado- Anschutz Medical Campus - PPDS | Denver | Colorado | 80262 | — |
| Yale University | New Haven | Connecticut | 06510 | — |
| Georgetown University | Washington D.C. | District of Columbia | 20007 | — |
| Whitman-Walker Health | Washington D.C. | District of Columbia | 20009 | — |
| CAN Community Health | Fort Lauderdale | Florida | 33316 | — |
| Midway Immunology and Research Center | Ft. Pierce | Florida | 34982 | — |
| CAN Community Health | Miami Gardens | Florida | 33055 | — |
| Midland Research Group, Inc. | Oakland Park | Florida | 33334 | — |
| Orlando Immunology Center | Orlando | Florida | 32803 | — |
| AHF (AIDS Healthcare Foundation) - Pensacola Research | Pensacola | Florida | 32504 | — |
| CAN Community Health | Sarasota | Florida | 34237 | — |
| St. Josephs Comprehensive Research Institute | Tampa | Florida | 33607 | — |
| Emory University | Atlanta | Georgia | 30308 | — |
| Infectious Disease Specialists of Atlanta | Decatur | Georgia | 30033 | — |
| Mercer University | Macon | Georgia | 31201 | — |
| Chatham CARE Center | Savannah | Georgia | 31401 | — |
| Howard Brown Health | Chicago | Illinois | 60613 | — |
| Indiana University School of Medicine | Indianapolis | Indiana | 46202 | — |
| The Brigham and Women's Hospital, Inc. | Boston | Massachusetts | 02115 | — |
| Boston Medical Center | Boston | Massachusetts | 02118 | — |
| Community Research Initiative | Boston | Massachusetts | 02129 | — |
| Be Well Medical Center | Berkley | Michigan | 48072 | — |
| Trinity Health | Grand Rapids | Michigan | 49503 | — |
| KC CARE Health Center | Kansas City | Missouri | 64111 | — |
| ID CARE | Hillsborough | New Jersey | 08844 | — |
| Saint Michael's Medical Center | Newark | New Jersey | 07102 | — |
| South Jersey Infectious Disease | Somers Point | New Jersey | 08244 | — |
| AXCES Research Group - Albuquerque | Santa Fe | New Mexico | 87505 | — |
| Brooklyn Clinical Research Center | Brooklyn | New York | 11226 | — |
| New York Presbyterian Hospital | Flushing | New York | 11355 | — |
| Jacobi Medical Center | The Bronx | New York | 10461 | — |
| Montefiore Medical Center | The Bronx | New York | 10467 | — |
| CTRC University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | — |
| Atrium Health Infectious Disease Kenilworth | Charlotte | North Carolina | 28207 | — |
| Duke University | Durham | North Carolina | 27710 | — |
| Brody School of Medicine at East Carolina University Adult Specialty Care | Greenville | North Carolina | 27858 | — |
| Rosedale Health and Wellness | Huntersville | North Carolina | 28078 | — |
| University of Cincinnati | Cincinnati | Ohio | 45267 | — |
| MetroHealth Medical Center | Cleveland | Ohio | 44109 | — |
| Ohio State University | Columbus | Ohio | 43210 | — |
| Prisma Health/USC | Columbia | South Carolina | 29203 | — |
| Central Texas Clinical Research | Austin | Texas | 78705 | — |
| North Texas Infectious Diseases Consultants | 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 | — |
| 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 | — |
| MultiCare Institute for Research & Innovation | Spokane | Washington | 99202 | — |
| University of Wisconsin-Madison | Madison | Wisconsin | 53705 | — |
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 46 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06630286, 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 30, 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 NCT06630286 live on ClinicalTrials.gov.