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

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.

Conditions

HIV-1-infection

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Study Overview

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Study Details

Study overview

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.

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)

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

Condition
HIV-1-infection
Intervention / Treatment

-

Contacts and Locations

Los Angeles

Ruane Clinical Research Group, Inc, Los Angeles, California, United States, 90036

Los Angeles

Mills Clinical Research, Los Angeles, California, United States, 90069

San Francisco

Optimus Medical Group, San Francisco, California, United States, 94102

Denver

Vivent Health, Denver, Colorado, United States, 80246

Fort Lauderdale

CAN Community Health, Fort Lauderdale, Florida, United States, 33316

Fort Pierce

Midway Immunology and Research Center, Fort Pierce, Florida, United States, 34982

Miami Gardens

CAN Community Health, Miami Gardens, Florida, United States, 33055

Orlando

Orlando Immunology Center, Orlando, Florida, United States, 32803

Pensacola

AHF (AIDS Healthcare Foundation) - Pensacola Research, Pensacola, Florida, United States, 32504

Sarasota

CAN Community Health, Sarasota, Florida, United States, 34237

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Gilead Sciences,

Gilead Study Director, STUDY_DIRECTOR, Gilead Sciences

Study Record Dates

2030-08