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NCT05502341 · ClinicalTrials.gov registry record · Phase 2

Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen

A Phase 2 study of HIV-1-infection, sponsored by Gilead Sciences.

Active
Registry status
Phase 2
Development phase
689
Enrollment target
20
Study locations

NCT05502341 is a Phase 2 study of HIV-1-infection that is active but no longer recruiting, run by Gilead Sciences. The registered enrollment target is 689 participants, above the 342-participant average among 71 other HIV-1-infection trials with a reported enrollment target (101% higher). The trial reports 20 study locations across 5 states.

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The verdict

NCT05502341, a Phase 2 study of HIV-1-infection, is active but no longer recruiting, sponsored by Gilead Sciences.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
689 participants
Enrollment target
20
Study locations

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

FieldValue
Enrollment Target 689 participants
Start Date 2022-08-16
Est. Completion 2028-07
Phase Phase 2

Sponsor

Gilead Sciences

504 total trials

What the Registry Record Tells You About NCT05502341

The ClinicalTrials.gov registry entry for NCT05502341 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 689 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 342-participant average among 71 other HIV-1-infection trials with a reported enrollment target (101% 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 Lenacapavir is the first listed.

NCT05502341 reports 20 study locations spanning 5 distinct geographic areas - top geographies include Florida, California, Colorado.

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.

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).

Who is sponsoring clinical trial NCT05502341?

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

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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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.