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
Sponsors and collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Lead sponsor
University of Oxford
Collaborator
Gilead Sciences
Collaborator