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ACTIVE NOT RECRUITING
NCT05052996
PHASE2

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

Sponsor: Gilead Sciences

View on ClinicalTrials.gov

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.

Official title: A Phase 2 Randomized, Open-Label, Active-Controlled Study Evaluating the Safety and Efficacy of an Oral Weekly Regimen of Islatravir in Combination With Lenacapavir in Virologically Suppressed People With HIV

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

142

Start Date

2021-10-05

Completion Date

2028-03

Last Updated

2026-02-04

Healthy Volunteers

No

Conditions

Interventions

DRUG

ISL

Capsules administered orally without regard to food

DRUG

LEN

Tablets administered orally without regard to food

DRUG

B/F/TAF

Tablets administered orally without regard to food

DRUG

ISL/LEN FDC

Tablets administered orally without regard to food

Locations (44)

Pacific Oaks Medical Group

Beverly Hills, California, United States

Ruane Clinical Research Group, Inc

Los Angeles, California, United States

Mills Clinical Research

Los Angeles, California, United States

Hoag Medical Group - Newport Beach

Newport Beach, California, United States

BIOS Clinical Research

Palm Springs, California, United States

Optimus Medical Group

San Francisco, California, United States

Public Health Institute at Denver Health

Denver, Colorado, United States

Vivent Health

Denver, Colorado, United States

Washington Health Institute

Washington D.C., District of Columbia, United States

The George Washington University Medical Faculty Associates Inc.

Washington D.C., District of Columbia, United States

CAN Community Health Care, Inc.

Fort Lauderdale, Florida, United States

Midway Immunology and Research Center

Ft. Pierce, Florida, United States

JEM Research Institute

Lake Worth, Florida, United States

Schiff Center for Liver Diseases/University of Miami

Miami, Florida, United States

Floridian Clinical Research

Miami Lakes, Florida, United States

Orlando Immunology Center

Orlando, Florida, United States

Emory University Hospital Midtown Infectious Disease Clinic

Atlanta, Georgia, United States

Atlanta ID Group, PC

Atlanta, Georgia, United States

Metro Infectious Disease Consultants

Decatur, Georgia, United States

Chatham County Health Department

Savannah, Georgia, United States

John A. Burns School of Medicine, University of Hawaii Clinics at Kaka'ako

Honolulu, Hawaii, United States

Howard Brown Health Center

Chicago, Illinois, United States

Northstar Healthcare

Chicago, Illinois, United States

Indiana CTSI Clinical Research Center

Indianapolis, Indiana, United States

Boston Medical Center

Boston, Massachusetts, United States

AccessHealth MA

Boston, Massachusetts, United States

Be Well Medical Center

Berkley, Michigan, United States

Hennepin Healthcare HCMC

New Brighton, Minnesota, United States

Southampton Healthcare, Inc.

St Louis, Missouri, United States

Huntridge Family Clinic

Las Vegas, Nevada, United States

ID Care

Hillsborough, New Jersey, United States

AXCES Research Group

Santa Fe, New Mexico, United States

New York-Presbyterian Queens

Flushing, New York, United States

Jacobi Medical Center

The Bronx, New York, United States

NC TraCS Institute - CTRC: University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Penn Medicine: Perelman Center for Advanced Medicine at the Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Philadelphia FIGHT Community Health Centers

Philadelphia, Pennsylvania, United States

Central Texas Clinical Research, LLC

Austin, Texas, United States

AIDS Arms Inc

Dallas, Texas, United States

North Texas Infectious Diseases Consultants, P.A.

Dallas, Texas, United States

The Crofoot Research Center, INC

Houston, Texas, United States

Peter Shalit, M.D.

Seattle, Washington, United States

MultiCare Rockwood Main Clinic

Spokane, Washington, United States

Community Health Care

Tacoma, Washington, United States