drugset / Trial / NCT05769569
Safety and Efficacy of Neutralizing Antibodies and Vaccination for Induction of HIV Remission
Phase 1
Withdrawn
Henry M. Jackson Foundation for the Advancement of Military Medicine
Janssen Vaccines & Prevention B.V. · collabUS Military HIV Research Program · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a phase I, randomized, open-label trial to investigate the safety of VRC07-523LS, PGDM1400LS and N-803 in combination with Ad26.Mos4.HIV, MVA-Bavarian Nordic (BN)-HIV and A244d11gp120/ALFQ vaccination, and the impact on time to sustained viral rebound of ≥1000 copies/mL for 4 consecutive weeks during analytic treatment interruption (ATI) in people living with human immunodeficiency virus-1 (HIV-1, PLWH) who initiated antiretroviral therapy (ART) during acute HIV-1 infection (AHI).
Timeline
- Start
- 2023-09-01
- Primary completion
- 2025-07-01
- Completion
- 2025-07-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | A244d11 gp120 | Protein / enzyme biologic | 300 ug | Intramuscular |
| Subject | Ad26.Mos4.HIV | Vaccine | 5e+10 unknown | Intramuscular |
| Subject | Army Liposome Formulation | Other / unclassified | 200 ug | Intramuscular |
| Subject | MVA-BN-HIV | Vaccine | 2e+08 unknown | Intramuscular |
| Subject | N-803 | Protein / enzyme biologic | 6 ug/kg | Subcutaneous |
| Subject | PGDM1400LS | Monoclonal antibody | 20 mg/kg | Intravenous |
| Subject | VRC07-523LS | Monoclonal antibody | 10 mg/kg | Intravenous |