Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen
Public ClinicalTrials.gov record NCT05502341. 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, Open-label, Multicenter, Active-Controlled Study to Evaluate the Safety and Efficacy of Bictegravir/Lenacapavir Versus Stable Baseline Regimen in Virologically Suppressed People With HIV-1 on Stable Complex Treatment Regimens
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 effects of switching to the study drugs, bictegravir (BIC) plus lenacapavir (LEN), versus current therapy (Phase 2) and BIC/LEN fixed-dose combination (FDC) versus current therapy (Phase 3) in people living with HIV (PWH).
Study identification
- NCT ID
- NCT05502341
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 689 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
- Aug 16, 2022 (Actual)
- Primary completion
- Sep 29, 2025 (Actual)
- Completion
- Jul 2028 (Estimated)
- Last update posted
- Aug 10, 2026
2022 – 2028
United States locations
- U.S. sites
- 40
- U.S. states
- 15
- U.S. cities
- 37
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Be Well Medical Center | Berkeley | California | 48072 | — |
| Pacific Oaks Medical Group | Beverly Hills | California | 90211 | — |
| Ruane Clinical Research Group, Inc | Los Angeles | California | 90036 | — |
| Alta Bates Summit Medical Center, Summit Campus, East Bay Advanced Care | Oakland | California | 94609 | — |
| Bios Clinical Research | Palm Springs | California | 92262 | — |
| University of California San Diego (UCSD) | San Diego | California | 92103 | — |
| Lundquist Institute for Biomedical Innovation at Harbor - UCLA Medical Center | Torrance | California | 90502 | — |
| The Men's Health Foundation | West Hollywood | California | 90046 | — |
| Denver Health Medical Center | Denver | Colorado | 80204 | — |
| Yale University; School of Medicine; AIDS Program | New Haven | Connecticut | 06510 | — |
| Midland Florida Clinical Research Center, LLC | DeLand | Florida | 32720 | — |
| Therafirst Medical Centers | Fort Lauderdale | Florida | 33308 | — |
| Gary Richmond, MD, PA, Inc. | Fort Lauderdale | Florida | 33316 | — |
| Midway Immunology & Research Center, LLC | Ft. Pierce | Florida | 34982 | — |
| Schiff Center for liver Diseases/University of Miami | Miami | Florida | 33136 | — |
| Floridian Clinical Research | Miami Lakes | Florida | 33016 | — |
| Orlando Immunology Center | Orlando | Florida | 32803 | — |
| Therapeutic Concepts, PA | Orlando | Florida | 32803 | — |
| Triple O Research Institute PA | West Palm Beach | Florida | 33407 | — |
| Atlanta ID Group | Atlanta | Georgia | 30309 | — |
| Mercer University School of Medicine | Macon | Georgia | 31201 | — |
| Howard Brown Health Center | Chicago | Illinois | 60613 | — |
| Kansas City Care Clinic | Kansas City | Missouri | 64111 | — |
| Southampton Healthcare, Inc. | St Louis | Missouri | 63139 | — |
| Saint Michael's Medical Center | Newark | New Jersey | 07102 | — |
| AXCES Research Group | Santa Fe | New Mexico | 87505 | — |
| New York Presbyterian Hospital | Flushing | New York | 11355 | — |
| Ricky K. Hsu, MD, PC | New York | New York | 10001 | — |
| University of North Carolina - Chapel Hill | Chapel Hill | North Carolina | 27514 | — |
| East Carolina University | Greenville | North Carolina | 27858 | — |
| Philadelphia FIGHT | Philadelphia | Pennsylvania | 19107 | — |
| Medical University of South Carolina (MUSC) Research NEXUS | Charleston | South Carolina | 29425 | — |
| Central Texas Clinical Research | Austin | Texas | 78705 | — |
| St. Hope Foundation | Bellaire | Texas | 77401 | — |
| AIDS Arms, Inc., DBA Prism Health North Texas | Dallas | Texas | 75208 | — |
| North Texas Infectious Diseases Consultants | Dallas | Texas | 75246 | — |
| Texas Centers for Infectious Disease Associates | Fort Worth | Texas | 76104 | — |
| Gordon E. Crofoot MD PA | Houston | Texas | 77098 | — |
| Diagnostic Clinic of Longview - 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 54 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05502341, 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 Aug 10, 2026 · Synced Oct 17, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05502341 live on ClinicalTrials.gov.