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

Study acronym: HIVGP-BCG
StatusActive, Not Recruiting
PhaseEarly Phase 1
Started

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Trial flagged as At Risk
Primary completion moved at least 10 months later Aug 18, 2026 → Jun 18, 2027
See other at-risk trials from Han Xu, M.D., Ph.D., FAPCR, Medical Director, IRB Chair

Record History

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  1. Primary completion pushed from Aug 18, 2026 to Jun 18, 2027 Show 6 more changesShow less
    • Sponsor changed: Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair to Han Xu, M.D., Ph.D., FAPCR, Medical Director, IRB Chair
    • Start date: Sep 12, 2025 to Oct 5, 2026
    • Study completion pushed from Oct 28, 2026 to Oct 28, 2027
    • Eligibility criteria expanded, about 15 words
    • Study description expanded, about 10 words
    • Publications: details revised at 2 of 2 entries
  2. Interventions: HIV Therapeutic Biologic Mix - HIV GP120 plus HIV GP41 plus BCG Vaccine Mix for percutaneous use (Biological) to HIV Therapeutic Biologic Mix - HIV GP160 plus BCG Vaccine Mix for percutaneous use (Biological)
    • Study description shortened, about 14 words
    v2
  3. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07182838
Lead Sponsor Han Xu, M.D., Ph.D., FAPCR, Medical Director, IRB Chair
Collaborators: UnitedHealthcare
Conditions
(from sponsor)		 HIV Infections
Related terms Acquired Immunodeficiency Syndrome, HIV Infections
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov