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

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

About this trial

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).

Eligibility criteria

Qualifiers

Provision of written informed consent.

History of Initiation of combination ART within 90 days of acute HIV diagnosis

On ART for at least 12 months with no known ART interruption >28 consecutive days within 12 months prior to Step 1 Study Entry

ART with an integrase inhibitor-based regimen with two NRTIs or dolutegravir/lamivudine regimen for at least 6 weeks prior to Study Entry.

Disqualifiers

Currently pregnant or breastfeeding or planning to become pregnant during study participation.

Prior receipt of anti-HIV broadly neutralizing antibody therapy.

Receipt of any non-HIV monoclonal antibody therapy within 1 year prior to study entry.

Prior receipt of a latency-reversing agent (LRA).

Trial design

Treatments tested in this trial

  • ChAdOx1.tHIVconsv1
  • ChAdOx1.HIVconsv62
  • MVA.tHIVconsv3
  • MVA.tHIVconsv4
  • Vesatolimod (VES)
  • GS-5423
  • GS-2872
  • MVA.tHIVconsv4
  • Placebo

Treatment groups

36 Participants
are divided into 2 treatment groups

Sponsors and collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Lead sponsor

University of Oxford

Collaborator

Gilead Sciences

Collaborator