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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 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.

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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

Sponsor

Gilead Sciences

504 total trials

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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, categorized as Phase 3. The registered enrollment target is 600 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 343-participant average among 71 other HIV-1-infection trials with a reported enrollment target (75% higher). The listed sponsor is Gilead Sciences, which has 504 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 8 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.