A Double-Blind, Randomized, Placebo-Controlled Clinical Trial of Combination HIV-Specific Broadly Neutralizing Monoclonal Antibodies Combined with ART Initiation during Acute HIV Infection to Induce HIV Remission

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Description

Scientists are looking for ways to minimize the distribution of HIV-1 in the body, especially where anti-HIV medications (ART) are unable to reach. Starting ART as soon as possible following a diagnosis of Acute HIV Infection (AHI) has been shown to better preserve the immune system. Broadly neutralizing antibodies (bNAbs), when administered with ART, also have the potential to prevent the HIV virus from being able to reproduce.. This is a randomized, placebo-controlled research study that will enroll adults with recently diagnosed AHI. All participants will begin ART at entry and receive a single dose of two bNAbs (VRC07-523LS and PGT121.414.LS) or placebos. Everyone will be followed for about 1 year after starting ART, then stop ART for up to 2.5 years, then be followed for 1 year after restarting ART.

Details
Age

Adult

Eligibility

Documentation of recently confirmed HIV-1 (acute infection). Be between 18 and 70 years old. Be willing to take broadly neutralizing antibodies and start treatment for HIV. Not have taken pre-exposure ART (PrEP) within the past 60 days... No active hepatitis B or C infection or significant heart condition.

Locations

Outpatient CTRC
University of Colorado Hospital

Principal Investigator
Photograph of Thomas Campbell

Thomas Campbell

Study ID

Protocol Number: 23-0252

More information available at ClinicalTrials.gov: NCT05719441

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