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Active, not recruiting Phase 3

Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed People With HIV-1

NCT06630286 · tracked via the Priya Life Science Japan tracker
Phase
Phase 3
Started
2024-10-09
Last updated
2026-04-30

Condition(s) studied

HIV-1-infection

Investigational drug(s) / intervention(s)

ISL/LEN →B/F/TAF →PTM B/F/TAFPTM ISL/LEN

ISL/LEN: Tablet administered orally

B/F/TAF: Tablet administered orally

PTM B/F/TAF: Tablet administered orally

PTM ISL/LEN: Tablet administered orally

Study summary

The goal of this clinical study is to learn about the safety and efficacy of switching to once weekly tablet of islatravir/lenacapavir (ISL/LEN) regimen versus continuing standard treatment of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in people with human immunodeficiency virus (PWH) who are virologically suppressed (HIV-1 RNA levels \< 50 copies/mL) on B/F/TAF for ≥ 6 months prior to screening.

The primary objective is to evaluate the efficacy of switching to oral weekly ISL/LEN tablet regimen versus continuing B/F/TAF in virologically suppressed PWH at Week 48.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Key Inclusion Criteria: * HIV-1 RNA \< 50 copies/mL for ≥ 6 months before screening, as documented by: 1. One HIV-1 RNA \< 50 copies/mL immediately preceding the 24 week period prior to screening. 2. Within 24 weeks prior to screening, if HIV-1 RNA results are available, all levels must be \< 50 copies/mL. 3. During the 6 to 12 months period prior to screening, transient detectable viremia ≥ 50 copies/mL is acceptable ("blip"), as long as it is not confirmed on 2 consecutive visits. * Plasma HIV-1 RNA levels \< 50 copies/mL at screening. * Individuals are receiving B/F/TAF for ≥ 6 months prior to screening and willing to continue until Day 1. * Individuals assigned female at birth and of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified methods of contraception. Key Exclusion Criteria: * Prior virologic failure. * Prior use of, or exposure to ISL or LEN. * Active, serious infections requiring parenteral therapy within 30 days before randomization. * Active tuberculosis infection. * Acute hepatitis within 30 days before randomization. * Hepatitis B virus (HBV) infection as determined below at the screening visit: 1. Positive HBV surface antigen OR 2. Positive HBV core antibody and negative HBV surface antibody. Note: individuals found to be susceptible to HBV infection (eg negative hepatitis B surface antibody at the screening visit, regardless of prior HBV vaccination history) should be recommended to receive HBV vaccination. * Active hepatitis C virus (HCV) coinfection, defined as detectable HCV RNA. Note: individuals with prior/inactive HCV infection (defined as undetectable HCV RNA) may be enrolled. * Any of the following laboratory values at screening: 1. Creatinine clearance (CLcr) ≤ 30 mL/min according to the Cockcroft-Gault formula 2. Alanine aminotransferase \> 5 x upper limit of normal (ULN) 3. Direct bilirubin \> 1.5 x ULN 4. Platelets \< 50,000/μL 5. Hemoglobin \< 8.0 g/dL Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcome measure(s)

  • Proportion of Participants with HIV-1 RNA ≥ 50 Copies/mL at Week 48 as Determined by the United States (US) Food and Drug Administration (FDA)-Defined Snapshot Algorithm — Week 48

Trial sites (106)

FacilityCityRegionStatus
University of Alabama at Birmingham Birmingham Alabama
Pueblo Family Physicians Phoenix Arizona
Kaiser Permanente Southern California Los Angeles California
Ruane Clinical Research Group, Inc Los Angeles California
Mills Clinical Research Los Angeles California
BIOS Clinical Research Palm Springs California
Optimus Medical Group San Francisco California
Vivent Health Denver Colorado
University of Colorado- Anschutz Medical Campus - PPDS Denver Colorado
Yale University New Haven Connecticut
Georgetown University Washington D.C. District of Columbia
Whitman-Walker Health Washington D.C. District of Columbia
CAN Community Health Fort Lauderdale Florida
Midway Immunology and Research Center Ft. Pierce Florida
CAN Community Health Miami Gardens Florida
Midland Research Group, Inc. Oakland Park Florida
Orlando Immunology Center Orlando Florida
AHF (AIDS Healthcare Foundation) - Pensacola Research Pensacola Florida
CAN Community Health Sarasota Florida
St. Josephs Comprehensive Research Institute Tampa Florida
Emory University Atlanta Georgia
Infectious Disease Specialists of Atlanta Decatur Georgia
Mercer University Macon Georgia
Chatham CARE Center Savannah Georgia
Howard Brown Health Chicago Illinois
Indiana University School of Medicine Indianapolis Indiana
The Brigham and Women's Hospital, Inc. Boston Massachusetts
Boston Medical Center Boston Massachusetts
Community Research Initiative Boston Massachusetts
Be Well Medical Center Berkley Michigan
Trinity Health Grand Rapids Michigan
KC CARE Health Center Kansas City Missouri
ID CARE Hillsborough New Jersey
Saint Michael's Medical Center Newark New Jersey
South Jersey Infectious Disease Somers Point New Jersey
AXCES Research Group - Albuquerque Santa Fe New Mexico
Brooklyn Clinical Research Center Brooklyn New York
New York Presbyterian Hospital Flushing New York
Jacobi Medical Center The Bronx New York
Montefiore Medical Center The Bronx New York

+ 66 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06630286 on ClinicalTrials.gov ↗ ← All trials in Japan