LAST UPDATED
February 04, 2026
Clinicaltrials.gov ID
OVERVIEW
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
PROTOCOL 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.
View moreParticipation requirements
Age
18 years +
Sex
All
Healthy Volunteers
No
Age
18 years +
Sex
All
Healthy Volunteers
No
Study details
Medical Condition
HIV-1 Infection
Gender
N/A
Date
October 2021 - December 2023
Study Type
Interventional
Study Phase
Phase 2
Product
ISL, LEN, B/F/TAF, ISL/LEN FDC
Eligibility information
Inclusion criteria
- Received bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) for ≥ 24 weeks at screening.
- Documented plasma human immunodeficiency virus type 1 (HIV-1) ribonucleic acid (RNA) < 50 copies/mL (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL) for ≥ 24 weeks before and at screening.
- Plasma HIV-1 RNA < 50 copies/mL at screening.
Exclusion criteria
- History of prior virologic failure while receiving treatment for HIV-1.
- Prior use of, or exposure to, islatravir (ISL) or lenacapavir (LEN).
- Active, serious infections requiring parenteral therapy < 30 days before randomization.
- Active or occult hepatitis B virus (HBV) coinfection, defined as hepatitis B core antibody (HBcAb) positive, hepatitis B surface antigen (HBsAg) positive, or HBV deoxyribonucleic acid (DNA) positive as determined by the central laboratory.
- Active hepatitis C virus (HCV) coinfection, defined as detectable HCV RNA.
- Any of the following laboratory values at screening:
- Creatinine clearance (CLcr) ≤ 30 mL/min according to the Cockcroft-Gault formula
- CD4+ T-cells < 200 cells/mm^3 (Cohort 1); CD4+ T-cells < 350 cells/mm^3 (cohort 2).
- Absolute lymphocyte count < 900 cells/mm^3 (cohort 2).
- Individuals of childbearing potential (as defined in protocol) who have a positive serum pregnancy test at screening or positive urine and serum pregnancy tests at Day 1 prior to study drug administration.
- Individuals who plan to continue breastfeeding during the study.
- Documented historical or screening resistance reports showing nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) or non-nucleoside/nucleotide reverse transcriptase inhibitors (NNRTIs) resistance mutations in reverse transcriptase, including M184V/I (Cohort 2).
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Locations
Locations (44)
Pacific Oaks Medical Group
Beverly Hills, California, United States, 90211
Ruane Clinical Research Group, Inc
Los Angeles, California, United States, 90036
Mills Clinical Research
Los Angeles, California, United States, 90069
Hoag Medical Group - Newport Beach
Newport Beach, California, United States, 92663
BIOS Clinical Research
Palm Springs, California, United States, 92262
Optimus Medical Group
San Francisco, California, United States, 94102
Public Health Institute at Denver Health
Denver, Colorado, United States, 80204
Washington Health Institute
Washington D.C., District of Columbia, United States, 20017
The George Washington University Medical Faculty Associates Inc.
Washington D.C., District of Columbia, United States, 20037
CAN Community Health Care, Inc.
Fort Lauderdale, Florida, United States, 33316
Midway Immunology and Research Center
Ft. Pierce, Florida, United States, 34982
Schiff Center for Liver Diseases/University of Miami
Miami, Florida, United States, 33136
Floridian Clinical Research
Miami Lakes, Florida, United States, 33016
Emory University Hospital Midtown Infectious Disease Clinic
Atlanta, Georgia, United States, 30308
Metro Infectious Disease Consultants
Decatur, Georgia, United States, 30033
Chatham County Health Department
Savannah, Georgia, United States, 31401
John A. Burns School of Medicine, University of Hawaii Clinics at Kaka'ako
Honolulu, Hawaii, United States, 96813
Indiana CTSI Clinical Research Center
Indianapolis, Indiana, United States, 46202
Hennepin Healthcare HCMC
New Brighton, Minnesota, United States, 55112
Southampton Healthcare, Inc.
St Louis, Missouri, United States, 63139
New York-Presbyterian Queens
Flushing, New York, United States, 11355
NC TraCS Institute - CTRC: University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Penn Medicine: Perelman Center for Advanced Medicine at the Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Philadelphia FIGHT Community Health Centers
Philadelphia, Pennsylvania, United States, 19107
Central Texas Clinical Research, LLC
Austin, Texas, United States, 78705
North Texas Infectious Diseases Consultants, P.A.
Dallas, Texas, United States, 75246
The Crofoot Research Center, INC
Houston, Texas, United States, 77098
MultiCare Rockwood Main Clinic
Spokane, Washington, United States, 99202
Join Gilead Trial Connect and help advance clinical research. Your participation is key to developing future treatments.
Share Trial