NCT07182838

Proof-of-Concept Clinical Pharmacology Trial for HIV Antigen Presentation Therapeutic Biologic Mix

Conducting an Initial Small, Controlled Clinical Pharmacology Trial to Assess for Therapeutic Biologics Activity (Proof-of-Concept) That Suggests the Potential for Clinical Benefits of HIV (+) Patients

• Status: Active Not Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair · Industry
• Sex: All
• Age: 24 Years – 64 Years
• Healthy volunteers: Not accepted

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.

Detailed description

* Conducting an initial small, controlled trial to assess therapeutic biologics activity (proof-of-concept) that suggests the potential for clinical benefit of HIV (+) patients without AIDS * 20 HIV (+) patients with AIDS * Positive HIV testing by standard RT-PCR assay or equivalent testing * No symptoms of AIDS * No clinical signs indicative of Severe or Critical Illness Severity * HIV GP160 0.1 mg x 1 mL plus BCG Organism 50 MG Mix * By the percutaneous route with the multiple puncture device * Negative HIV testing by standard RT-PCR assay or equivalent testing after percutaneous use 3 weeks. * Positive IGRA blood test with GP160 antigen after percutaneous use 21 days. * Our trial duration will be up to 4 weeks.

Conditions

• HIV Infections

Interventions

Type	Name	Description
BIOLOGICAL	HIV Therapeutic Biologic Mix - HIV GP160 plus BCG Vaccine Mix for percutaneous use	* By the percutaneous route with the multiple puncture device * HIV GP160 0.1 mg x 1 mL plus BCG Organism 50 MG Mix

Timeline

• Start date: 2025-09-12
• Primary completion: 2026-08-18
• Completion: 2026-10-28
• First posted: 2025-09-19
• Last updated: 2025-10-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study