drugset / Trial / NCT06071767
Evaluation of Safety, Immunogenicity and Efficacy of a Triple Immune Regimen in Adults Initiated on ART During Acute HIV-1
Phase 1/2
Suspended
36 enrolled
National Institute of Allergy and Infectious Diseases (NIAID)
Gilead Sciences · collabUniversity of Oxford · collab
RandomizedParallel-groupDouble-blindTreatment
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).
Timeline
- Start
- 2024-04-01
- Primary completion
- 2028-04-29
- Completion
- 2029-08-01
Outcome
Outcome not reported
Stopped (Enrollment): “Temporarily Closed (Paused) to Accrual and Study Agents/Products”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ChAdOx1.HIVconsv62 | Vaccine | 0.3 ml | Intramuscular |
| Subject | ChAdOx1.tHIVconsv1 | Vaccine | 0.4 ml | Intramuscular |
| Subject | GS-2872 | Unknown | — | Intravenous |
| Subject | MVA.tHIVconsv3 | Vaccine | 0.3 ml | Intramuscular |
| Subject | MVA.tHIVconsv4 | Vaccine | 0.5 ml | Intramuscular |
| Subject | Teropavimab | Monoclonal antibody | — | Intravenous |
| Subject | Vesatolimod | Small molecule | 8 mg | Oral |