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Evaluation of Safety, Immunogenicity and Efficacy of a Triple Immune Regimen in Adults Initiated on ART During Acute HIV-1

NCT06071767 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2026-02-09

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety, tolerability, and efficacy of therapeutic vaccination with chimpanzee adenovirus ChAdOx1- and poxvirus modified vaccinia Ankara (MVA)-vectored conserved mosaic T-cell vaccines in a sequential regimen with the toll-like receptor 7 (TLR7) agonist vesatolimod (VES) and two broadly neutralizing antibodies (bNAbs) compared to placebo, to induce HIV-1 control during analytic treatment interruption (ATI).

Conditions

Interventions

BIOLOGICAL

ChAdOx1.tHIVconsv1

Administered as 0.4 mL intramuscularly (IM) at Week 0

BIOLOGICAL

ChAdOx1.HIVconsv62

Administered as 0.3 mL IM at Week 0

BIOLOGICAL

MVA.tHIVconsv3

Administered as 0.3 mL IM at Week 4

BIOLOGICAL

MVA.tHIVconsv4

Administered as 0.5 mL IM at week 4

DRUG

Vesatolimod (VES)

VES 6 mg administered orally once every 2 weeks for two doses, then VES 8 mg once every 2 weeks for 8 doses. Dose escalation may be held or the 8 mg dose may be reduced for intolerability for weeks 6 through 24.

DRUG

GS-5423

Administered via intravenous (IV) infusion at week 7

DRUG

GS-2872

Administered via IV infusion at week 7

BIOLOGICAL

MVA.tHIVconsv4

Administered 0.5 mL IM at week 60

BIOLOGICAL

Placebo

Placebos for vaccines, VES, and bnAbs

Sponsors & Collaborators

  • University of Oxford

    collaborator OTHER

  • Gilead Sciences

    collaborator INDUSTRY

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Sharon Riddler, MD, MPH · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-01
Primary Completion
2028-04-29
Completion
2029-08-01
FDA Drug
Yes

Countries

  • United States
  • Brazil

Study Locations

More Related Trials

Entities

Drugs
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 NCT06071767 on ClinicalTrials.gov