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Studies

Interventional Active not recruiting Phase 3

NCT06630299 on ClinicalTrials.gov

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

Official title: A Phase 3, Randomized, Open-Label, Active-Controlled Study to Evaluate a Switch to an Oral Weekly Islatravir/Lenacapavir Regimen in People With HIV-1 Who Are Virologically Suppressed on Standard of Care

  • Sponsor: Gilead Sciences (Group)
  • Collaborators: Merck Sharp & Dohme LLC
  • Enrollment: 600 (Estimated)
  • Study start: 2024-10-08 (Actual)
  • Primary completion: 2026-04-23 (Actual)
  • Study completion: 2030-08-01 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • Masking: None
  • PrimaryPurpose: Treatment

Brief 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.

Conditions

  • HIV-1-Infection

Intervention / Treatment

  • Drug: ISL/LEN
  • Drug: Antiretroviral Combinations

Primary Outcome Measures

  • 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)

Countries

Argentina, Australia, Germany, Japan, Netherlands, Poland, Puerto Rico, South Africa, Spain, Switzerland, Taiwan, Thailand, United Kingdom, United States

Locations and Investigators

  • Samodzielny Publiczny Wojewodzki Szpital Zespolony W Szczecinie, Szczecin, Poland
    • Miłosz, Parczewski
  • Wroclawskie Centrum Zdrowia Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Wroclaw, Poland
    • Bartosz, Szetela
  • Amsterdam UMC Stichting, Amsterdam, Netherlands
    • Marc, Van der Valk
  • Leids Universitair Medisch Centrum (LUMC), Leiden, Netherlands
    • Anna, Roukens
  • MVZ Care, Munich, Germany
    • Celia, Jonsson-Oldenbüttel
  • Dr. Scholten & Schneeweiß GbR, Cologne, Germany
    • Stefan, Scholten
  • Medizinische Hochschule Hannover, Hanover, Germany
    • Georg, Behrens
  • Mannheimer Onkologie Praxis, Mannheim, Germany
    • Roger, Vogelmann
  • Hospital Universitario La Paz, Madrid, Spain
    • Juan, Gonzalez Garcia
  • University Hospital Virgen Del Rocio S.L., Sevilla, Spain
    • Nuria, Espinosa Aguilera
  • Hospital Germans Trias I Pujol, Badalona, Spain
    • Patricia, Echeverria
  • Hospital Universitario 12 De Octubre, Madrid, Spain
    • Maria, de Lagarde Sebastian

Study Officials

  • Gilead Study Director (Study Director) — Gilead Sciences