drugset / Trial / NCT07182838
Proof-of-Concept Clinical Pharmacology Trial for HIV Antigen Presentation Therapeutic Biologic Mix
Phase 0
Active not recruiting
20 enrolled
Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair
UnitedHealthcare · collab
NaSingle-groupOpen-labelHealth-services research
Summary
Conducting an initial small, controlled clinical pharmacology trial to assess for therapeutic biologics activity (proof-of-concept) that suggests the potential for clinical benefit of HIV (+) patients 1. Treat Infection of Multiple Gene Mutation HIV Virus Strains. 2. Activate Human Antigen Presentation Reaction to HIV Specific Antigen. 3. The human antigen presenting cells (APCs) can take up and process HIV target antigen protein into small peptide fragments, and then HIV virus can be killed by APCs directly.
Timeline
- Start
- 2025-09-12
- Primary completion
- 2026-08-18
- Completion
- 2026-10-28
Publications
- Background Netea MG, Joosten LA, Latz E, Mills KH, Natoli G, Stunnenberg HG, O'Neill LA, Xavier RJ. Trained immunity: A program of innate immune memory in health and disease. Science. 2016 Apr 22;352(6284):aaf1098. doi: 10.1126/science.aaf1098. Epub 2016 Apr 21.
- Background Netea MG, Dominguez-Andres J, Barreiro LB, Chavakis T, Divangahi M, Fuchs E, Joosten LAB, van der Meer JWM, Mhlanga MM, Mulder WJM, Riksen NP, Schlitzer A, Schultze JL, Stabell Benn C, Sun JC, Xavier RJ, Latz E. Defining trained immunity and its role in health and disease. Nat Rev Immunol. 2020 Jun;20(6):375-388. doi: 10.1038/s41577-020-0285-6. Epub 2020 Mar 4.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BCG Organism | Vaccine | 50 mg | Other |
| Subject | gp160 | Vaccine | 0.1 mg | Intravenous |