RecruitingPhase 1NCT06484335

RV630 - Approach to Control HIV With Immune Enhancement and Vaccination (ACHIEV

RV630 - Approach to Control HIV With Immune Enhancement and Vaccination (ACHIEV): Safety and Efficacy of Broadly Neutralizing Antibodies Combined With Therapeutic Vaccination for the Induction of HIV Remission

Sponsor

Henry M. Jackson Foundation for the Advancement of Military Medicine

Enrollment

48 participants

Start Date

Mar 27, 2025

Study Type

INTERVENTIONAL

Conditions

HIV Infections ART Acute HIV Infection PLWH

Summary

This is a phase I, randomized, double-blind, placebo-controlled clinical trial to investigate the safety of VRC07-523LS and PGDM1400LS in combination with ChAdOx1.tHIVconsv1, ChAdOx1.HIVconsv62 prime, MVA.tHIVconsv4 and A244d11gp120/ALFQ vaccination, and the impact on viral load setpoint during analytic treatment interruption (ATI) in people living with human immunodeficiency virus-1 (HIV-1, PLWH) who have initiated or will initiate antiretroviral therapy (ART) during acute HIV-1 infection (AHI).

Eligibility

Min Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying a new approach to controlling HIV using immune-boosting treatments and a vaccine strategy in people who were treated very early after being infected with HIV. The goal is to see if the immune system can be trained to better keep HIV in check. **You may be eligible if...** - You are a Thai national between 18 and 60 years old - You have confirmed HIV-1 infection and started antiretroviral therapy (ART) during the very early (acute) phase of infection - You have been on uninterrupted ART for at least 48 weeks and are currently on an integrase inhibitor-based regimen - Your HIV viral load has been undetectable on your current regimen - You are in generally good health **You may NOT be eligible if...** - You are not a Thai national - You started HIV treatment after the acute infection window - You have had recent changes to your HIV medications - You are on a long-acting injectable ART regimen - You have significant health conditions that would affect participation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALVRC07-523LS

VRC07-523LS (VRC-HIVMAB075-00-AB) is a recombinant human immunoglobulin G1 (IgG1) broadly neutralizing monoclonal antibody (bNAb) directed against the HIV-1 CD4 binding site

BIOLOGICALPGDM1400LS

PGDM1400LS is a recombinant human IgG1 bNAb targeted against the HIV-1 V2 apex epitope region.

BIOLOGICALChAdOx1.tHIVconsv1

ChAdOx1.tHIVconsv1 is a replication-deficient virus expressing six conserved sub-protein regions of Gag and Pol (regions 1-6) of HIV-1 as one chimeric protein designated HIVconsv1.

BIOLOGICALChAdOx1.HIVconsv62

ChAdOx1.HIVconsv62 is a replication-deficient virus expressing six conserved sub-protein regions of Gag and Pol (regions 1-6) of HIV-1 as one chimeric protein designated HIVconsv62.

BIOLOGICALMVA.tHIVconsv4

MVA.tHIVconsv4 is a recombinant, non-replicating Modified Vaccinia Ankara (MVA) virus expressing six conserved sub-protein regions of Gag and Pol (regions 1-6) of HIV-1 as one chimeric protein designated tHIVconsv4.

BIOLOGICALA244d11 gp120

A244d11 gp120, consists of the gp120 envelope glycoprotein HIV-1 subtype CRF\_01AE A244 derived from the CM244 CRF\_01AE strain, with an 11 amino N-terminal deletion. It is a modification of the A244 rgp120 immunogen from the AIDSVAX®B/E vaccine.

BIOLOGICALALFQ

ALFQ (Army Liposome Formulation, ALF) is a liposomal adjuvant containing a synthetic

OTHERPlacebo

Normal saline (0.9% sodium chloride for injection) will be used as a placebo.

Locations(1)

The Faculty of Medicine, Chulalongkorn University/ King Chulalongkorn Memorial Hospital

Pathum Wan, Bangkok, Thailand

View Full Details on ClinicalTrials.gov

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NCT06484335

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