Study Evaluating the Safety and Efficacy of Islatravir in Combination With Lenacapavir in Virologically Suppressed People With HIV
NCT ID: NCT05052996
Last Updated: 2026-02-04
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE2
142 participants
INTERVENTIONAL
2021-10-05
2028-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort 1 (ISL+LEN)
Participants will receive the following for at least 48 weeks:
* Day 1 and Day 2: ISL 40 and LEN 600 mg
* Day 8 and weekly thereafter (ie, every 7 days): ISL 20 mg and LEN 300 mg
ISL
Capsules administered orally without regard to food
LEN
Tablets administered orally without regard to food
Cohort 1 (B/F/TAF to ISL+LEN)
Participants will receive bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) 50/200/25 mg once daily for at least 48 weeks
After 48 weeks, participants will switch from B/F/TAF to ISL+LEN
* ISL 40 and LEN 600 mg on Day 1 and Day 2
* ISL 20 mg and LEN 300 mg weekly
Participants who do not switch from B/F/TAF to ISL+LEN at Week 48 will be discontinued from the study.
ISL
Capsules administered orally without regard to food
LEN
Tablets administered orally without regard to food
B/F/TAF
Tablets administered orally without regard to food
Cohort 2 (ISL+LEN)
Participants will receive the following for at least 48 weeks
* Day 1: LEN oral 600 mg (2 x 300 mg) and ISL 2 mg (2 x 1 mg)
* Day 2: LEN only oral 600 mg (2 x 300 mg)
* Day 8 and weekly thereafter (ie, every 7 days): LEN oral 300 mg (1 x 300 mg) and ISL 2 mg
ISL
Capsules administered orally without regard to food
LEN
Tablets administered orally without regard to food
Cohort 2 (B/F/TAF to ISL+LEN)
Participants will receive B/F/TAF 50/200/25 mg once daily for at least 48 weeks.
ISL
Capsules administered orally without regard to food
LEN
Tablets administered orally without regard to food
B/F/TAF
Tablets administered orally without regard to food
Extension Phase Cohort 2 of ISL/LEN Fixed Dose Combination (FDC)
After 48 Weeks of randomized treatment, all participants will be given an option to participate in an Extension Phase to receive ISL+LEN or ISL/LEN FDC tablet (when available) until ISL/LEN becomes available or until the sponsor elects to discontinue the study, whichever occurs first.
Participants receiving ISL+LEN during the randomized phase will continue to take ISL + LEN weekly.
Participants receiving B/F/TAF during the randomized phase will switch to ISL+LEN:
* Day 1: LEN oral 600 mg (2 x 300 mg) and ISL 2 mg (2 x 1 mg)
* Day 2: LEN only oral 600 mg (2 x 300 mg)
* Day 8 and weekly thereafter (ie, every 7 days): LEN oral 300 mg (1 x 300 mg) and ISL 2 mg
Participants who do not switch from B/F/TAF to ISL+LEN at Week 48 will be discontinued from the study.
All participants in the extension phase will be transitioned to weekly ISL/LEN FDC (Dose A) tablet when it becomes available.
ISL/LEN FDC
Tablets administered orally without regard to food
Interventions
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ISL
Capsules administered orally without regard to food
LEN
Tablets administered orally without regard to food
B/F/TAF
Tablets administered orally without regard to food
ISL/LEN FDC
Tablets administered orally without regard to food
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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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
Countries
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References
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Colson AE, Crofoot GE, Ruane PJ, Ramgopal MN, Dretler AW, Nahass RG, Sinclair GI, Berhe M, Roberts A, Applin S, Brinson C, Jayaweera D, Workowski KA, Shihadeh F, Liu SY, Klopfer S, Llamoso C, Madera S, Dvory-Sobol H, Rhee MS, Rhee EG, Baeten JM, Eron JJ. Once-Weekly Oral Islatravir Plus Lenacapavir Versus Daily Oral Bictegravir, Emtricitabine, and Tenofovir Alafenamide in Persons With HIV-1 : A Phase 2 Randomized Study. Ann Intern Med. 2025 Dec 23. doi: 10.7326/ANNALS-25-01939. Online ahead of print.
Provided Documents
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Document Type: Study Protocol: Protocol Amendment 6
Document Type: Study Protocol: Protocol Amendment 5
Document Type: Statistical Analysis Plan
Related Links
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Gilead Clinical Trials Website
Other Identifiers
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GS-US-563-6041
Identifier Type: -
Identifier Source: org_study_id
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