Study Details

Participation Requirements

Age

18 Years +

Sex

All

Healthy Volunteers

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

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

Vivent Health

Denver, Colorado, United States, 80246

Washington Health Institute

Washington, District of Columbia, United States, 20017

The George Washington University Medical Faculty Associates Inc.

Washington, District of Columbia, United States, 20037

CAN Community Health Care, Inc.

Fort Lauderdale, Florida, United States, 33316

Midway Immunology and Research Center

Fort Pierce, Florida, United States, 34982

JEM Research Institute

Lake Worth, Florida, United States, 33462

Floridian Clinical Research

Miami Lakes, Florida, United States, 33016

Schiff Center for Liver Diseases/University of Miami

Miami, Florida, United States, 33136

Orlando Immunology Center

Orlando, Florida, United States, 32803

Emory University Hospital Midtown Infectious Disease Clinic

Atlanta, Georgia, United States, 30308

Atlanta ID Group, PC

Atlanta, Georgia, United States, 30309

Infectious Disease Specialists of Atlanta

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

Howard Brown Health Center

Chicago, Illinois, United States, 60613

Northstar Healthcare

Chicago, Illinois, United States, 60657

Indiana CTSI Clinical Research Center

Indianapolis, Indiana, United States, 46202

Boston Medical Center

Boston, Massachusetts, United States, 02118

AccessHealth MA

Boston, Massachusetts, United States, 02129

Be Well Medical Center

Berkley, Michigan, United States, 48072

Hennepin Healthcare HCMC

New Brighton, Minnesota, United States, 55112

Southampton Healthcare, Inc.

Saint Louis, Missouri, United States, 63139

Huntridge Family Clinic

Las Vegas, Nevada, United States, 89104

ID Care

Hillsborough, New Jersey, United States, 08844

AXCES Research Group

Santa Fe, New Mexico, United States, 87505

Jacobi Medical Center

Bronx, New York, United States, 10461

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

AIDS Arms Inc

Dallas, Texas, United States, 75208

North Texas Infectious Diseases Consultants, P.A.

Dallas, Texas, United States, 75246

The Crofoot Research Center, INC

Houston, Texas, United States, 77098

Peter Shalit, M.D.

Seattle, Washington, United States, 98104

MultiCare Rockwood Main Clinic

Spokane, Washington, United States, 99202

Community Health Care

Tacoma, Washington, United States, 98405

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

OVERVIEW

PROTOCOL SUMMARY