Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy
Condition(s) studied
Investigational drug(s) / intervention(s)
Bictegravir/Lenacapavir (BIC/LEN) FDC: Tablets administered orally without regard to food
Lenacapavir: Tablets administered orally without regard to food
B/F/TAF: Tablets administered orally without regard to food
Placebo to match B/F/TAF: Tablets administered orally without regard to food
Placebo to match BIC/LEN FDC: Tablets administered orally without regard to food
Placebo to match Lenacapavir: Tablets administered orally without regard to food
Study summary
The goal of this clinical study is to learn more about the effects of switching to the study drugs, bictegravir (BIC)/lenacapavir (LEN), fixed-dose combination (FDC) versus current therapy bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) FDC in people living with HIV-1 (PWH) who are successfully treated with B/F/TAF (virologically suppressed).
The primary objective of this study is to evaluate the efficacy of switching to BIC/LEN (75/50 mg) FDC tablets versus continuing on B/F/TAF (50/200/25 mg) FDC tablets in virologically suppressed PWH.
Eligibility
Primary outcome measure(s)
- Percentage of Participants With Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) ≥ 50 Copies/mL at Week 48 as Determined by the United States Food and Drug Administration (US FDA) Defined Snapshot Algorithm — Week 48
Participants who had the last available on-treatment HIV-1 RNA≥ 50 copies/mL in the Week 48 analysis window, or who did not have on-treatment HIV-1 RNA data in the Week 48 analysis window and participants who discontinued study drug prior to or in the Week 48 analysis window due to lack of efficacy, or who discontinued study drug prior to or in the Week 48 analysis window due to reasons other than adverse event (AE), death, or lack of efficacy and have the last available on-treatment HIV-1 RNA ≥ 50 copies/mL were included. The Week 48 window was between Days 295 and 378 (inclusively). Percentages were rounded off.
Trial sites (104)
| Facility | City | Region | Status |
|---|---|---|---|
| Pueblo Family Physicians | Phoenix | Arizona | |
| Be Well Medical Center | Berkeley | California | |
| Pacific Oaks Medical Group | Beverly Hills | California | |
| Ruane Clinical Research Group Inc. | Los Angeles | California | |
| Alta Bates Summit Medical Center, Summit Campus, East Bay Advanced Care | Oakland | California | |
| BIOS Clinical Research | Palm Springs | California | |
| UCSD Anti Viral Research Centre (AVRC) | San Diego | California | |
| Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center | Torrance | California | |
| Mills Clinical Research | West Hollywood | California | |
| Public Health Institute at Denver Health | Denver | Colorado | |
| Yale University School of Medicine (study visits) | New Haven | Connecticut | |
| Midland Florida Infectious Diseases Specialists, PL - Orange City | DeLand | Florida | |
| Therafirst Medical Center | Fort Lauderdale | Florida | |
| CAN Community Health | Fort Lauderdale | Florida | |
| Midway Immunology and Research Center | Ft. Pierce | Florida | |
| AIDS Healthcare Foundation - The Kinder Medical Group | Miami | Florida | |
| Schiff Center for liver Diseases/University of Miami | Miami | Florida | |
| Floridian Clinical Research | Miami Lakes | Florida | |
| Orlando Immunology Center | Orlando | Florida | |
| Bliss Healthcare | Orlando | Florida | |
| AHF Pensacola | Pensacola | Florida | |
| CAN community Health | Sarasota | Florida | |
| Triple O Research Institute, P.A. | West Palm Beach | Florida | |
| Infectious Disease Specialists of Atlanta | Decatur | Georgia | |
| Mercer University, Department of Internal Medicine | Macon | Georgia | |
| Claudia T Martorell MD LLC dba The Research Institute | Springfield | Massachusetts | |
| Henry Ford Health | Detroit | Michigan | |
| KC Care health Center | Kansas City | Missouri | |
| Southampton Community Healthcare, Inc. | St Louis | Missouri | |
| ID Care, LLC | Hillsborough | New Jersey | |
| Saint Michael's Medical Center | Newark | New Jersey | |
| New Jersey Medical School - Clinical Research Center | Newark | New Jersey | |
| South Jersey Infectious Disease | Somers Point | New Jersey | |
| AXCES Research Group, LLC | Santa Fe | New Mexico | |
| New York-Presbyterian Queens | Flushing | New York | |
| Montefiore Medical Center | The Bronx | New York | |
| The Brody School of Medicine at East Carolina University , ECU Adult Specialty Care | Greenville | North Carolina | |
| Rosedale Health and Wellness | Huntersville | North Carolina | |
| Philadelphia FIGHT Community Health Centers | Philadelphia | Pennsylvania | |
| Medical University of South Carolina (MUSC) Research Nexus | Charleston | South Carolina |
+ 64 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 NCT06333808 on ClinicalTrials.gov ↗ ← All trials in the USA