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NCT06630286 · ClinicalTrials.gov registry record · Phase 3

Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Bictegravir/Emtricitabine/Tenofovir Alafenamide 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
609
Enrollment target
20
Study locations

NCT06630286 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 609 participants, above the 343-participant average among 71 other HIV-1-infection trials with a reported enrollment target (78% higher). The trial reports 20 study locations across 7 states.

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The verdict

NCT06630286, 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
609 participants
Enrollment target
20
Study locations

Study Summary

The goal of this clinical study is to learn about the safety and efficacy of switching to once weekly tablet of islatravir/lenacapavir (ISL/LEN) regimen versus continuing standard treatment of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in people with human immunodeficiency virus (PWH) who are virologically suppressed (HIV-1 RNA levels \< 50 copies/mL) on B/F/TAF for ≥ 6 months prior to screening. The primary objective is to evaluate the efficacy of switching to oral weekly ISL/LEN tablet regimen versus continuing B/F/TAF in virologically suppressed PWH at Week 48.

Conditions Studied

HIV-1-infection

Interventions

  • DRUG B/F/TAF
  • DRUG ISL/LEN
  • DRUG PTM B/F/TAF
  • DRUG PTM ISL/LEN

Study Locations (20)

Florida

  • CAN Community Health - Fort Lauderdale
  • Midway Immunology and Research Center - Ft. Pierce
  • CAN Community Health - Miami Gardens
  • Midland Research Group, Inc. - Oakland Park
  • Orlando Immunology Center - Orlando
  • AHF (AIDS Healthcare Foundation) - Pensacola Research - Pensacola
  • CAN Community Health - Sarasota
  • St. Josephs Comprehensive Research Institute - Tampa

California

  • Kaiser Permanente Southern California - Los Angeles
  • Ruane Clinical Research Group, Inc - Los Angeles
  • Mills Clinical Research - Los Angeles
  • BIOS Clinical Research - Palm Springs
  • Optimus Medical Group - San Francisco

Colorado

  • Vivent Health - Denver
  • University of Colorado- Anschutz Medical Campus - PPDS - Denver

District of Columbia

  • Georgetown University - Washington D.C.
  • Whitman-Walker Health - Washington D.C.

Alabama

  • University of Alabama at Birmingham - Birmingham

Arizona

  • Pueblo Family Physicians - Phoenix

Connecticut

  • Yale University - New Haven

Trial Details

FieldValue
Enrollment Target 609 participants
Start Date 2024-10-09
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 NCT06630286

The ClinicalTrials.gov registry entry for NCT06630286 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 609 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 (78% 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 4 interventions - of which B/F/TAF is the first listed.

NCT06630286 reports 20 study locations spanning 7 distinct geographic areas - top geographies include Florida, California, Colorado.

Frequently Asked Questions

What is clinical trial NCT06630286 about?

NCT06630286 is a clinical study titled "Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed People With HIV-1". The goal of this clinical study is to learn about the safety and efficacy of switching to once weekly tablet of islatravir/lenacapavir (ISL/LEN) regimen versus continuing standard treatment of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in people with human immunodeficiency virus (PWH)...

What is the current status of trial NCT06630286?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 609 participants. The study started on 2024-10-09. Estimated completion is 2030-08.

What conditions does trial NCT06630286 study?

This clinical trial studies the following conditions: HIV-1-infection.

What interventions are being tested in trial NCT06630286?

The interventions under investigation include: B/F/TAF (DRUG), ISL/LEN (DRUG), PTM B/F/TAF (DRUG), PTM ISL/LEN (DRUG).

Who is sponsoring clinical trial NCT06630286?

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

Where is trial NCT06630286 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.