Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05502341 · ClinicalTrials.gov registry record · Phase 2
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen
A Phase 2 study of HIV-1-infection, sponsored by Gilead Sciences.
- Active
- Registry status
- Phase 2
- Development phase
- 689
- Enrollment target
- 20
- Study locations
NCT05502341: Active Phase 2 study of HIV-1-infection, sponsored by Gilead Sciences.
NCT05502341 is a Phase 2 study of HIV-1-infection that is active but no longer recruiting, run by Gilead Sciences. The registered enrollment target is 689 participants, above the 342-participant average among 71 other HIV-1-infection trials with a reported enrollment target (101% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05502341, a Phase 2 study of HIV-1-infection, is active but no longer recruiting, sponsored by Gilead Sciences.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 689 participants
- Enrollment target
- 20
- Study locations
Study Summary
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).
Conditions Studied
Interventions
- DRUG Lenacapavir
- DRUG BIC/LEN FDC
- DRUG Bictegravir
- DRUG Stable Baseline Regimen
Study Locations (20)
Florida
- Midland Florida Clinical Research Center, LLC - DeLand
- Therafirst Medical Centers - Fort Lauderdale
- Gary Richmond, MD, PA, Inc. - Fort Lauderdale
- Midway Immunology & Research Center, LLC - Ft. Pierce
- Schiff Center for liver Diseases/University of Miami - Miami
- Floridian Clinical Research - Miami Lakes
- Orlando Immunology Center - Orlando
- Therapeutic Concepts, PA - Orlando
- Triple O Research Institute PA - West Palm Beach
California
- Be Well Medical Center - Berkeley
- Pacific Oaks Medical Group - Beverly Hills
- Ruane Clinical Research Group, Inc - Los Angeles
- Alta Bates Summit Medical Center, Summit Campus, East Bay Advanced Care - Oakland
- Bios Clinical Research - Palm Springs
- University of California San Diego (UCSD) - San Diego
- Lundquist Institute for Biomedical Innovation at Harbor - UCLA Medical Center - Torrance
- The Men's Health Foundation - West Hollywood
Colorado
- Denver Health Medical Center - Denver
Connecticut
- Yale University; School of Medicine; AIDS Program - New Haven
Georgia
- Atlanta ID Group - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 689 participants |
| Start Date | 2022-08-16 |
| Est. Completion | 2028-07 |
| Phase | Phase 2 |
What the registry record for NCT05502341 still lists
NCT05502341 is an interventional study that assigns participants to a tested intervention. The registered 689 participants enrollment target is mid-sized for trials with a published cap, above the 342-participant average among 71 other HIV-1-infection trials with a reported enrollment target (101% higher).
The record links to 1 condition, with HIV-1-infection appearing as the primary indexed condition, and to 4 interventions - of which Lenacapavir is the first listed.
NCT05502341 names 20 study sites across 5 states, led by Florida, California, Colorado.
Frequently Asked Questions
What is clinical trial NCT05502341 about?
NCT05502341 is a clinical study titled "Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen". 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).
What is the current status of trial NCT05502341?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 689 participants. The study started on 2022-08-16. Estimated completion is 2028-07.
What conditions does trial NCT05502341 study?
This clinical trial studies the following conditions: HIV-1-infection.
What interventions are being tested in trial NCT05502341?
The interventions under investigation include: Lenacapavir (DRUG), BIC/LEN FDC (DRUG), Bictegravir (DRUG), Stable Baseline Regimen (DRUG).
Who is sponsoring clinical trial NCT05502341?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05502341 being conducted?
This trial has 20 study locations across California, Colorado, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for HIV-1-infection
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05502341's enrollment target sits among peer trials
689 4th of 71 higher than 68 of 71 other HIV-1-infection trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV-1-infection trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Improving Coronary Vascular Health in Women
RECRUITING · Phase 2
-
Tesamorelin as an Adjunct to Exercise for Improving Physical Function in HIV
RECRUITING · Phase 2
-
PrEPsmart 2-1-1 Pilot
RECRUITING · Phase 2
-
A Clinical Trial of STP0404 in Adults With HIV-1 Infection
RECRUITING · Phase 2
-
Anti-retroviral Therapy, Medications for Opioid Use Disorder, Opioids and HIV Infection - Study 1
RECRUITING · Phase 2
-
Evaluation of Long-Acting Lenacapavir for the Treatment of HIV-1 in Treatment-experienced Adolescents and Children
RECRUITING · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00532051 · 690 participants
Intraocular Lens Power Calculation After Laser Refractive Surgery Based on Optical Coherence Tomography
- NCT05184335 · 690 participants · Phase 3
Safety and Efficacy of Brilaroxazine (RP5063) in Schizophrenia
- NCT07221149 · 690 participants · Phase 2
A Study to Evaluate the Safety and Efficacy of Pumitamig in Combination With Chemotherapy Versus Nivolumab in Combination With Chemotherapy in Participants With Previously Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma (ROSETTA Gastric-204)
- NCT05750654 · 688 participants · NA
Effectiveness of Small Phlebotomy Tubes in Reducing Blood Transfusions in Adult Medical Intensive Care Unit and Intermediate Care Unit Patients With Anemia
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI