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
To find out if bNAbs, VRC07-523LS and PGT121.414.LS, are safe for administration with ART. To evaluate if the bNAbs are effective at keeping HIV from reproducing. It is necessary to stop taking ART after receiving the bNAbs or placebos for bNAbs. This is referred to as an ATI (analytical treatment interruption).
Why this Research Matters
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.
Who can Participate
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.
Study ID
Protocol Number: 23-0252
More information available at ClinicalTrials.gov: NCT05719441
Meet the Team
Principal Investigator