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

NCT06484335 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2025-09-16

No results posted yet for this study

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).

Conditions

  • HIV Infections
  • PLWH
  • ART
  • Acute HIV Infection

Interventions

BIOLOGICAL

VRC07-523LS

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

BIOLOGICAL

PGDM1400LS

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

BIOLOGICAL

ChAdOx1.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.

BIOLOGICAL

ChAdOx1.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.

BIOLOGICAL

MVA.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.

BIOLOGICAL

A244d11 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.

BIOLOGICAL

ALFQ

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

OTHER

Placebo

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

Sponsors & Collaborators

  • US Military HIV Research Program

    collaborator NETWORK

  • Henry M. Jackson Foundation for the Advancement of Military Medicine

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-27
Primary Completion
2027-08-01
Completion
2027-08-01
FDA Drug
Yes

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06484335 on ClinicalTrials.gov