Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen
NCT05502341 · View on ClinicalTrials.gov ↗
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05502341
The ClinicalTrials.gov registry entry for NCT05502341 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 689 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gilead Sciences, which has 190 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05502341 reports 20 study locations spanning 5 distinct geographic areas — top geographies include Florida, California, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05502341?
This trial is sponsored by Gilead Sciences, which has 190 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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