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NCT05052996 · ClinicalTrials.gov registry record · Phase 2

Study Evaluating the Safety and Efficacy of Islatravir in Combination With Lenacapavir in Virologically Suppressed People With HIV

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

Active
Registry status
Phase 2
Development phase
142
Enrollment target
20
Study locations

NCT05052996 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 142 participants, below the 349-participant average among 71 other HIV-1-infection trials with a reported enrollment target (59% lower). The trial reports 20 study locations across 5 states.

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The verdict

NCT05052996, 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
142 participants
Enrollment target
20
Study locations

Study Summary

The primary objective of this study is to evaluate the efficacy of oral weekly islatravir (ISL) in combination with lenacapavir (LEN) in virologically suppressed people with HIV (PWH) at Week 24.

Conditions Studied

Interventions

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

Study Locations (20)

California

  • Pacific Oaks Medical Group - Beverly Hills
  • Ruane Clinical Research Group, Inc - Los Angeles
  • Mills Clinical Research - Los Angeles
  • Hoag Medical Group - Newport Beach - Newport Beach
  • BIOS Clinical Research - Palm Springs
  • Optimus Medical Group - San Francisco

Florida

  • CAN Community Health Care, Inc. - Fort Lauderdale
  • Midway Immunology and Research Center - Ft. Pierce
  • JEM Research Institute - Lake Worth
  • Schiff Center for Liver Diseases/University of Miami - Miami
  • Floridian Clinical Research - Miami Lakes
  • Orlando Immunology Center - Orlando

Georgia

  • Emory University Hospital Midtown Infectious Disease Clinic - Atlanta
  • Atlanta ID Group, PC - Atlanta
  • Metro Infectious Disease Consultants - Decatur
  • Chatham County Health Department - Savannah

Colorado

  • Public Health Institute at Denver Health - Denver
  • Vivent Health - Denver

District of Columbia

  • Washington Health Institute - Washington D.C.
  • The George Washington University Medical Faculty Associates Inc. - Washington D.C.

Trial Details

FieldValue
Enrollment Target 142 participants
Start Date 2021-10-05
Est. Completion 2028-03
Phase Phase 2

Sponsor

Gilead Sciences

504 total trials

What the Registry Record Tells You About NCT05052996

The ClinicalTrials.gov registry entry for NCT05052996 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 142 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 349-participant average among 71 other HIV-1-infection trials with a reported enrollment target (59% lower). 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.

NCT05052996 reports 20 study locations spanning 5 distinct geographic areas - top geographies include California, Florida, Georgia.

Frequently Asked Questions

What is clinical trial NCT05052996 about?

NCT05052996 is a clinical study titled "Study Evaluating the Safety and Efficacy of Islatravir in Combination With Lenacapavir in Virologically Suppressed People With HIV". The primary objective of this study is to evaluate the efficacy of oral weekly islatravir (ISL) in combination with lenacapavir (LEN) in virologically suppressed people with HIV (PWH) at Week 24.

What is the current status of trial NCT05052996?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 142 participants. The study started on 2021-10-05. Estimated completion is 2028-03.

What conditions does trial NCT05052996 study?

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

What interventions are being tested in trial NCT05052996?

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

Who is sponsoring clinical trial NCT05052996?

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

Where is trial NCT05052996 being conducted?

This trial has 20 study locations across California, Colorado, District of Columbia, 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.