Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Standard of Care in Virologically Suppressed People With HIV-1
Public ClinicalTrials.gov record NCT06630299. 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, Open-Label, Active-Controlled Study to Evaluate a Switch to an Oral Weekly Islatravir/Lenacapavir Regimen in People With HIV-1 Who Are Virologically Suppressed on Standard of Care
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 safety and efficacy of switching to a once weekly tablet of islatravir/lenacapavir (ISL/LEN) regimen versus continuing standard of care treatment in people with human immunodeficiency virus (PWH) who are virologically suppressed (HIV-1 RNA levels \< 50 copies/mL) on a stable standard of care regimen for ≥ 6 months prior to screening. The standard of care includes 2 or 3 medicines, antiretroviral agents (ARVs). The primary objective of the study is to evaluate the efficacy of switching to oral weekly ISL/LEN tablet regimen versus continuing standard of care in virologically suppressed PWH at Week 48.
Study identification
- NCT ID
- NCT06630299
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 600 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 8, 2024 (Actual)
- Primary completion
- Apr 23, 2026 (Actual)
- Completion
- Aug 2030 (Estimated)
- Last update posted
- May 29, 2026
2024 – 2030
United States locations
- U.S. sites
- 49
- U.S. states
- 22
- U.S. cities
- 44
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham(UAB) 1917 Research Clinic | Birmingham | Alabama | 35294 | — |
| Pueblo Family Physicians | Phoenix | Arizona | 85015 | — |
| Vv-Tmf-5366229 | Los Angeles | California | 90027 | — |
| Ruane Clinical Research Group | Los Angeles | California | 90036 | — |
| BIOS Clinical Research | Palm Springs | California | 92262 | — |
| Vivent Health | Denver | Colorado | 80246 | — |
| University of Colorado Clinical and Translational Research Center | Denver | Colorado | 80262 | — |
| Yale University; School of Medicine; AIDS Program | New Haven | Connecticut | 06510 | — |
| Georgetown University Medical Center | Washington D.C. | District of Columbia | 20007 | — |
| Aids Healthcare Foundation - Northpoint | Fort Lauderdale | Florida | 33308 | — |
| Midway Immunology and Research Center | Ft. Pierce | Florida | 34982 | — |
| CAN Community Health | Miami Gardens | Florida | 33055 | — |
| Orlando Immunology Center | Orlando | Florida | 32803 | — |
| AHF Pensacola | Pensacola | Florida | 32503 | — |
| CAN Community Health | Sarasota | Florida | 34237 | — |
| BayCare Health System, Inc./St. Joseph's Hospital | Tampa | Florida | 33607 | — |
| Triple O Research Institute, P.A. | West Palm Beach | Florida | 33401 | — |
| 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 | — |
| Howard Brown Health Center | Chicago | Illinois | 60613 | — |
| Indiana CTSI Clinical Research Center | Indianapolis | Indiana | 46202 | — |
| Brigham and Womens's Hospital | Boston | Massachusetts | 02115 | — |
| Boston Medical Center | Boston | Massachusetts | 02118 | — |
| Community Research Initiative of New England d/b/a Community Resource Initiative (CRI) | Boston | Massachusetts | 02129 | — |
| Be Well Medical Center | Berkley | Michigan | 48072 | — |
| Henry Ford Health | Detroit | Michigan | 48202 | — |
| Trinity Health Michigan d/b/a Trinity Health Grand Rapids Hospital | Grand Rapids | Michigan | 49503 | — |
| ID Care | Hillsborough | New Jersey | 08844 | — |
| 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 | — |
| Northwell Health/Division of Infectious Diseases | Manhasset | New York | 11030 | — |
| Jacobi Medical Center | The Bronx | New York | 10461 | — |
| Montefiore Medical Center | The Bronx | New York | 10467 | — |
| Duke University Health System(DUHS) | Durham | North Carolina | 27710 | — |
| ECU Health Leo Jenkins Cancer Building | Greenville | North Carolina | 27834 | — |
| Rosedale Health and Wellness | Huntersville | North Carolina | 28078 | — |
| University of Cincinnati College of Medicine | Cincinnati | Ohio | 45267 | — |
| Prisma Health Midlands - Clinical Research Unit | Columbia | South Carolina | 29203 | — |
| Central Texas Clinical Research | Austin | Texas | 78705 | — |
| 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 | — |
| Clinical Alliance for Research& Education - Infectious Diseases, LLC (CARE-ID) | Longview | Texas | 75605 | — |
| AXCES Research Group, LLC | Salt Lake City | Utah | 84102 | — |
| Clinical Alliance for Research& Education - Infectious Diseases, LLC | Annandale | Virginia | 22003 | — |
| MultiCare Rockwood Main Clinic | Spokane | Washington | 99202 | — |
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 51 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06630299, 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 May 29, 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 NCT06630299 live on ClinicalTrials.gov.