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Clinical Trials in the UK / NCT06630299
Active, not recruiting Phase 3

Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Standard of Care in Virologically Suppressed People With HIV-1

NCT06630299 · tracked via the Priya Life Science UK tracker
Sponsor
Gilead Sciences
Phase
Phase 3
Started
2024-10-08
Last updated
2026-05-29

Condition(s) studied

HIV-1-Infection

Investigational drug(s) / intervention(s)

ISL/LENAntiretroviral Combinations

ISL/LEN: Tablet administered orally

Antiretroviral Combinations: 2 or 3 antiretrovirals (ARVs) administered as defined by the investigator, according to the prescribing information.

Study summary

The goal of this clinical study is to learn more about the safety and efficacy of switching to a once weekly tablet of islatravir/lenacapavir (ISL/LEN) regimen versus continuing standard of care treatment in people with human immunodeficiency virus (PWH) who are virologically suppressed (HIV-1 RNA levels \< 50 copies/mL) on a stable standard of care regimen for ≥ 6 months prior to screening. The standard of care includes 2 or 3 medicines, antiretroviral agents (ARVs).

The primary objective of the study is to evaluate the efficacy of switching to oral weekly ISL/LEN tablet regimen versus continuing standard of care 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 weeks 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. * Are receiving guideline-recommended standard of care treatment such as International Antiviral Society (IAS), Department of Health and Human Services (DHHS), European AIDS Clinical Society (EACS) consisting of 2 or 3 ARVs for ≥ 6 months prior to screening and willing to continue until Day 1. Individuals in Treatment Group 2 must also be willing to continue their standard of care through at least Week 96. * 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 (ALT) \> 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)

Trial sites (100)

FacilityCityRegionStatus
University of Alabama at Birmingham(UAB) 1917 Research Clinic Birmingham Alabama
Pueblo Family Physicians Phoenix Arizona
Vv-Tmf-5366229 Los Angeles California
Ruane Clinical Research Group Los Angeles California
BIOS Clinical Research Palm Springs California
Vivent Health Denver Colorado
University of Colorado Clinical and Translational Research Center Denver Colorado
Yale University; School of Medicine; AIDS Program New Haven Connecticut
Georgetown University Medical Center Washington D.C. District of Columbia
Aids Healthcare Foundation - Northpoint Fort Lauderdale Florida
Midway Immunology and Research Center Ft. Pierce Florida
CAN Community Health Miami Gardens Florida
Orlando Immunology Center Orlando Florida
AHF Pensacola Pensacola Florida
CAN Community Health Sarasota Florida
BayCare Health System, Inc./St. Joseph's Hospital Tampa Florida
Triple O Research Institute, P.A. West Palm Beach Florida
Metro Infectious Disease Consultants, P.L.L.C. Decatur Georgia
Mercer University, Department of Internal Medicine Macon Georgia
Chatham County Health Department Savannah Georgia
Howard Brown Health Center Chicago Illinois
Indiana CTSI Clinical Research Center Indianapolis Indiana
Brigham and Womens's Hospital Boston Massachusetts
Boston Medical Center Boston Massachusetts
Community Research Initiative of New England d/b/a Community Resource Initiative (CRI) Boston Massachusetts
Be Well Medical Center Berkley Michigan
Henry Ford Health Detroit Michigan
Trinity Health Michigan d/b/a Trinity Health Grand Rapids Hospital Grand Rapids Michigan
ID Care Hillsborough New Jersey
Saint Michael's Medical Center Newark New Jersey
AXCES Research Group, LLC Santa Fe New Mexico
NewYork-Presbyterian Queens Flushing New York
Northwell Health/Division of Infectious Diseases Manhasset New York
Jacobi Medical Center The Bronx New York
Montefiore Medical Center The Bronx New York
Duke University Health System(DUHS) Durham North Carolina
ECU Health Leo Jenkins Cancer Building Greenville North Carolina
Rosedale Health and Wellness Huntersville North Carolina
University of Cincinnati College of Medicine Cincinnati Ohio
Prisma Health Midlands - Clinical Research Unit Columbia South Carolina

+ 60 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 NCT06630299 on ClinicalTrials.gov ↗ ← All trials in the UK