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NCT06630299 · ClinicalTrials.gov registry record · Phase 3

Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Standard of Care in Virologically Suppressed People With HIV-1

A Phase 3 study of HIV-1-infection, sponsored by Gilead Sciences.

Active
Registry status
Phase 3
Development phase
600
Enrollment target
20
Study locations

NCT06630299: Active Phase 3 study of HIV-1-infection, sponsored by Gilead Sciences.

NCT06630299 is a Phase 3 study of HIV-1-infection that is active but no longer recruiting, run by Gilead Sciences. The registered enrollment target is 600 participants, above the 343-participant average among 71 other HIV-1-infection trials with a reported enrollment target (75% higher). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06630299, a Phase 3 study of HIV-1-infection, is active but no longer recruiting, sponsored by Gilead Sciences.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
600 participants
Enrollment target
20
Study locations

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

HIV-1-infection

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

FieldValue
Enrollment Target 600 participants
Start Date 2024-10-08
Est. Completion 2030-08
Phase Phase 3
Gilead Sciences

504 total trials

What the registry record for NCT06630299 still lists

NCT06630299 is an interventional study that assigns participants to a tested intervention. The registered 600 participants enrollment target is mid-sized for trials with a published cap, above the 343-participant average among 71 other HIV-1-infection trials with a reported enrollment target (75% higher).

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.

NCT06630299 names 20 study sites across 8 states, led by Florida, California, Georgia.

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.

What interventions are being tested in trial NCT06630299?

The interventions under investigation include: ISL/LEN (DRUG), Antiretroviral Combinations (DRUG).

Who is sponsoring clinical trial NCT06630299?

This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.

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.

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 NCT06630299's enrollment target sits among peer trials

600 9th of 71 higher than 63 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

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Related registry views

Source: ClinicalTrials.gov NCT06630299, the US trial registry maintained by the National Library of Medicine. NCT06630299 (mid enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.