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Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Standard of Care in Virologically Suppressed People With HIV-1
NCT06630299 · View on ClinicalTrials.gov ↗
Study Summary
The goal of this clinical study is to learn more about the safety and efficacy of switching to a once weekly tablet of islatravir/lenacapavir (ISL/LEN) regimen versus continuing standard of care treatment in people with human immunodeficiency virus (PWH) who are virologically suppressed (HIV-1 RNA levels \< 50 copies/mL) on a stable standard of care regimen for ≥ 6 months prior to screening. The standard of care includes 2 or 3 medicines, antiretroviral agents (ARVs). The primary objective of the study is to evaluate the efficacy of switching to oral weekly ISL/LEN tablet regimen versus continuing standard of care in virologically suppressed PWH at Week 48.
Conditions Studied
Interventions
- DRUG ISL/LEN
- DRUG Antiretroviral Combinations
Study Locations (20)
Florida
- Aids Healthcare Foundation - Northpoint — Fort Lauderdale
- Midway Immunology and Research Center — Ft. Pierce
- CAN Community Health — Miami Gardens
- Orlando Immunology Center — Orlando
- AHF Pensacola — Pensacola
- CAN Community Health — Sarasota
- BayCare Health System, Inc./St. Joseph's Hospital — Tampa
- Triple O Research Institute, P.A. — West Palm Beach
California
- Vv-Tmf-5366229 — Los Angeles
- Ruane Clinical Research Group — Los Angeles
- BIOS Clinical Research — Palm Springs
Georgia
- Metro Infectious Disease Consultants, P.L.L.C. — Decatur
- Mercer University, Department of Internal Medicine — Macon
- Chatham County Health Department — Savannah
Colorado
- Vivent Health — Denver
- University of Colorado Clinical and Translational Research Center — Denver
Alabama
- University of Alabama at Birmingham(UAB) 1917 Research Clinic — Birmingham
Arizona
- Pueblo Family Physicians — Phoenix
Connecticut
- Yale University; School of Medicine; AIDS Program — New Haven
District of Columbia
- Georgetown University Medical Center — Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 600 participants |
| Start Date | 2024-10-08 |
| Est. Completion | 2030-08 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06630299
The ClinicalTrials.gov registry entry for NCT06630299 describes a study currently listed as active not recruiting. It is categorized as Phase 3, 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 600 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 2 interventions — of which ISL/LEN 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: NCT06630299 reports 20 study locations spanning 8 distinct geographic areas — top geographies include Florida, California, Georgia. 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 NCT06630299 about?
NCT06630299 is a clinical study titled "Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Standard of Care in Virologically Suppressed People With HIV-1". The goal of this clinical study is to learn more about the safety and efficacy of switching to a once weekly tablet of islatravir/lenacapavir (ISL/LEN) regimen versus continuing standard of care treatment in people with human immunodeficiency virus (PWH) who are virologically suppressed (HIV-1 RNA l...
What is the current status of trial NCT06630299?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 600 participants. The study started on 2024-10-08. Estimated completion is 2030-08.
What conditions does trial NCT06630299 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 NCT06630299?
The interventions under investigation include: ISL/LEN (DRUG), Antiretroviral Combinations (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06630299?
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 NCT06630299 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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