ACTIVE_NOT_RECRUITING

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

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Conditions

HIV-1-infection

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase 3, Randomized, Double-blind, Active-controlled Study to Evaluate a Switch to an Oral Weekly Islatravir/Lenacapavir Regimen in People With HIV-1 Who Are Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF)

Quick Facts

Study Start:2024-10-09
Study Completion:2030-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06630286

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * HIV-1 RNA \< 50 copies/mL for ≥ 6 months before screening, as documented by:
  2. 1. One HIV-1 RNA \< 50 copies/mL immediately preceding the 24 week period prior to screening.
  3. 2. Within 24 weeks prior to screening, if HIV-1 RNA results are available, all levels must be \< 50 copies/mL.
  4. 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.
  5. * Plasma HIV-1 RNA levels \< 50 copies/mL at screening.
  6. * Individuals are receiving B/F/TAF for ≥ 6 months prior to screening and willing to continue until Day 1.
  7. * Individuals assigned female at birth and of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified methods of contraception.
  1. * Prior virologic failure.
  2. * Prior use of, or exposure to ISL or LEN.
  3. * Active, serious infections requiring parenteral therapy within 30 days before randomization.
  4. * Active tuberculosis infection.
  5. * Acute hepatitis within 30 days before randomization.
  6. * Hepatitis B virus (HBV) infection as determined below at the screening visit:
  7. 1. Positive HBV surface antigen OR
  8. 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.
  9. * 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.
  10. * Any of the following laboratory values at screening:
  11. 1. Creatinine clearance (CLcr) ≤ 30 mL/min according to the Cockcroft-Gault formula
  12. 2. Alanine aminotransferase \> 5 x upper limit of normal (ULN)
  13. 3. Direct bilirubin \> 1.5 x ULN
  14. 4. Platelets \< 50,000/μL
  15. 5. Hemoglobin \< 8.0 g/dL

Contacts and Locations

Principal Investigator

Gilead Study Director
STUDY_DIRECTOR
Gilead Sciences

Study Locations (Sites)

University of Alabama at Birmingham
Birmingham, Alabama, 35294
United States
Pueblo Family Physicians
Phoenix, Arizona, 85015
United States
Kaiser Permanente Southern California
Los Angeles, California, 90027
United States
Ruane Clinical Research Group, Inc
Los Angeles, California, 90036
United States
Mills Clinical Research
Los Angeles, California, 90069
United States
BIOS Clinical Research
Palm Springs, California, 92262
United States
Optimus Medical Group
San Francisco, California, 94102
United States
Vivent Health
Denver, Colorado, 80246
United States
University of Colorado- Anschutz Medical Campus - PPDS
Denver, Colorado, 80262
United States
Yale University
New Haven, Connecticut, 06510
United States
Georgetown University
Washington, District of Columbia, 20007
United States
Whitman-Walker Health
Washington, District of Columbia, 20009
United States
CAN Community Health
Fort Lauderdale, Florida, 33316
United States
Midway Immunology and Research Center
Fort Pierce, Florida, 34982
United States
CAN Community Health
Miami Gardens, Florida, 33055
United States
Midland Research Group, Inc.
Oakland Park, Florida, 33334
United States
Orlando Immunology Center
Orlando, Florida, 32803
United States
AHF (AIDS Healthcare Foundation) - Pensacola Research
Pensacola, Florida, 32504
United States
CAN Community Health
Sarasota, Florida, 34237
United States
St. Josephs Comprehensive Research Institute
Tampa, Florida, 33607
United States
Emory University
Atlanta, Georgia, 30308
United States
Infectious Disease Specialists of Atlanta
Decatur, Georgia, 30033
United States
Mercer University
Macon, Georgia, 31201
United States
Chatham CARE Center
Savannah, Georgia, 31401
United States
Howard Brown Health
Chicago, Illinois, 60613
United States
Indiana University School of Medicine
Indianapolis, Indiana, 46202
United States
The Brigham and Women's Hospital, Inc.
Boston, Massachusetts, 02115
United States
Boston Medical Center
Boston, Massachusetts, 02118
United States
Community Research Initiative
Boston, Massachusetts, 02129
United States
Be Well Medical Center
Berkley, Michigan, 48072
United States
Trinity Health
Grand Rapids, Michigan, 49503
United States
KC CARE Health Center
Kansas City, Missouri, 64111
United States
ID CARE
Hillsborough, New Jersey, 08844
United States
Saint Michael's Medical Center
Newark, New Jersey, 07102
United States
South Jersey Infectious Disease
Somers Point, New Jersey, 08244
United States
AXCES Research Group - Albuquerque
Santa Fe, New Mexico, 87505
United States
Jacobi Medical Center
Bronx, New York, 10461
United States
Montefiore Medical Center
Bronx, New York, 10467
United States
Brooklyn Clinical Research Center
Brooklyn, New York, 11226
United States
New York Presbyterian Hospital
Flushing, New York, 11355
United States
CTRC University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
United States
Atrium Health Infectious Disease Kenilworth
Charlotte, North Carolina, 28207
United States
Duke University
Durham, North Carolina, 27710
United States
Brody School of Medicine at East Carolina University Adult Specialty Care
Greenville, North Carolina, 27858
United States
Rosedale Health and Wellness
Huntersville, North Carolina, 28078
United States
University of Cincinnati
Cincinnati, Ohio, 45267
United States
MetroHealth Medical Center
Cleveland, Ohio, 44109
United States
Ohio State University
Columbus, Ohio, 43210
United States
Prisma Health/USC
Columbia, South Carolina, 29203
United States
Central Texas Clinical Research
Austin, Texas, 78705
United States
North Texas Infectious Diseases Consultants
Dallas, Texas, 75246
United States
AXCES Research Group, LLC
El Paso, Texas, 79902
United States
Texas Centers for Infectious Disease Associates
Fort Worth, Texas, 76104
United States
The Crofoot Research Center, INC.
Houston, Texas, 77098
United States
DCOL Center for Clinical Research
Longview, Texas, 75605
United States
AXCES Research Group, LLC
Salt Lake City, Utah, 84102
United States
Clinical Alliance for Research & Education - Infectious Diseases, LLC (CARE-ID)
Annandale, Virginia, 22003
United States
Peter Shalit MD
Seattle, Washington, 98104
United States
MultiCare Institute for Research & Innovation
Spokane, Washington, 99202
United States
University of Wisconsin-Madison
Madison, Wisconsin, 53705
United States

Collaborators and Investigators

Sponsor: Gilead Sciences

  • Gilead Study Director, STUDY_DIRECTOR, Gilead Sciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-09
Study Completion Date2030-08

Study Record Updates

Study Start Date2024-10-09
Study Completion Date2030-08

Terms related to this study

Additional Relevant MeSH Terms

  • HIV-1-infection