RecruitingHIV-1-infection

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

Eligible age

18+ yrs

Accepts

All genders

Locations

10 states

Healthy volunteers

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About this study

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).

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

You may qualify if…

✓ 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.
✓ Willingness to participate in the ATI and willingness to restart ART according to study guidelines.
✓ Willingness to adhere to protocol therapy and complete all study visits.
✓ Weight ≥50 kg and ≤150 kg at Screening.
✓ CD4 cell count ≥450 cells/mm3 obtained within 60 days prior to Study Entry.

You may not qualify if…

✕ 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).
✕ Receipt of HIV-1 or other investigational vaccines within 6 months prior to Study Entry.
✕ Receipt of a live-virus vaccine within 60 days or any vaccination within 14 days prior to Study Entry.
✕ Receipt of any simian adenovirus-vectored vaccine (e.g., anti-COVID-19 AZD1222) within 12 months prior to Step 1 Study Entry.
✕ Known allergy/sensitivity or any hypersensitivity to components of study treatments or their formulations.