Study | Research Studies | School of Medicine

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

Primary Objective

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.

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Description

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).

Details

Age

Adult

Eligibility

-HIV-1 RNA < 50 copies/mL for at least 6 months before 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 a least 6 months prior to screening and willing to continue until Day 1.-HIV-1 RNA < 50 copies/mL for at least 6 months before 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 at least 6 months prior to screening and willing to continue until Day 1.

Locations

Adult Infectious Disease Clinical Trials Center
Outpatient CTRC
University of Colorado Hospital

Principal Investigator

Thomas Campbell

Study ID

Protocol Number: 24-1828

More information available at ClinicalTrials.gov: NCT06630299

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