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Combinatorial Therapy to Induce an HIV Remission

NCT04357821 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2026-02-24

Study results available
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Summary

Combination approaches will almost certainly be required to generate durable control of HIV in the absence of antiretroviral therapy (a "remission"). In this study, 20 individuals will receive a combination regimen administered during ART and then undergo an analytic treatment interruption (ATI).

Conditions

Interventions

DRUG

Combination Intervention

1. IL-12 adjuvanted p24CE DNA prime (p24CE/IL-12) at Weeks 0 and 4 2. IL-12 adjuvanted DNA boost (p24CE plus p55gag) at Week 12 3. MVA/HIV62B (MVA62B) boost at Week 20 4. single dose of two bNAbs (VRC07-523LS and 10-1074, which target CD4 binding site and V3 loop, respectively) at week 24 with a TLR9 agonist (lefitolimod) administered weekly between Weeks 24 and 33 (10 doses) 5. ATI with single dose of VRC07 and 10-1074 at Week 34

Sponsors & Collaborators

  • amfAR, The Foundation for AIDS Research

    collaborator OTHER

  • International AIDS Vaccine Initiative

    collaborator NETWORK

  • Ichor Medical Systems Incorporated

    collaborator INDUSTRY

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Rockefeller University

    collaborator OTHER

  • Mologen AG

    collaborator INDUSTRY

  • GeoVax, Inc.

    collaborator INDUSTRY

  • University of California, San Francisco

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2020-08-01
Primary Completion
2026-06-30
Completion
2026-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT04357821 on ClinicalTrials.gov