Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed People With HIV-1
Condition(s) studied
Investigational drug(s) / intervention(s)
ISL/LEN: Tablet administered orally
B/F/TAF: Tablet administered orally
PTM B/F/TAF: Tablet administered orally
PTM ISL/LEN: Tablet administered orally
Study summary
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.
Eligibility
Primary outcome measure(s)
- Proportion of Participants with HIV-1 RNA ≥ 50 Copies/mL at Week 48 as Determined by the United States (US) Food and Drug Administration (FDA)-Defined Snapshot Algorithm — Week 48
Trial sites (106)
| Facility | City | Region | Status |
|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | |
| Pueblo Family Physicians | Phoenix | Arizona | |
| Kaiser Permanente Southern California | Los Angeles | California | |
| Ruane Clinical Research Group, Inc | Los Angeles | California | |
| Mills Clinical Research | Los Angeles | California | |
| BIOS Clinical Research | Palm Springs | California | |
| Optimus Medical Group | San Francisco | California | |
| Vivent Health | Denver | Colorado | |
| University of Colorado- Anschutz Medical Campus - PPDS | Denver | Colorado | |
| Yale University | New Haven | Connecticut | |
| Georgetown University | Washington D.C. | District of Columbia | |
| Whitman-Walker Health | Washington D.C. | District of Columbia | |
| CAN Community Health | Fort Lauderdale | Florida | |
| Midway Immunology and Research Center | Ft. Pierce | Florida | |
| CAN Community Health | Miami Gardens | Florida | |
| Midland Research Group, Inc. | Oakland Park | Florida | |
| Orlando Immunology Center | Orlando | Florida | |
| AHF (AIDS Healthcare Foundation) - Pensacola Research | Pensacola | Florida | |
| CAN Community Health | Sarasota | Florida | |
| St. Josephs Comprehensive Research Institute | Tampa | Florida | |
| Emory University | Atlanta | Georgia | |
| Infectious Disease Specialists of Atlanta | Decatur | Georgia | |
| Mercer University | Macon | Georgia | |
| Chatham CARE Center | Savannah | Georgia | |
| Howard Brown Health | Chicago | Illinois | |
| Indiana University School of Medicine | Indianapolis | Indiana | |
| The Brigham and Women's Hospital, Inc. | Boston | Massachusetts | |
| Boston Medical Center | Boston | Massachusetts | |
| Community Research Initiative | Boston | Massachusetts | |
| Be Well Medical Center | Berkley | Michigan | |
| Trinity Health | Grand Rapids | Michigan | |
| KC CARE Health Center | Kansas City | Missouri | |
| ID CARE | Hillsborough | New Jersey | |
| Saint Michael's Medical Center | Newark | New Jersey | |
| South Jersey Infectious Disease | Somers Point | New Jersey | |
| AXCES Research Group - Albuquerque | Santa Fe | New Mexico | |
| Brooklyn Clinical Research Center | Brooklyn | New York | |
| New York Presbyterian Hospital | Flushing | New York | |
| Jacobi Medical Center | The Bronx | New York | |
| Montefiore Medical Center | The Bronx | New York |
+ 66 more sites — see the full list on the official registry below.
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06630286 on ClinicalTrials.gov ↗ ← All trials in Japan