Active — Not RecruitingEarly Phase 1

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

United States20 participantsStarted 2025-09-12

Plain-language 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.

Who can participate

Age range24 Years – 64 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

* Conducting an initial small, controlled trial to assess therapeutic biologics activity (proof-of-concept) that suggests the potential for clinical benefit of HIV (+) patients. * 20 HIV (+) patients Inclusion Criteria: * HIV Positive * Positive testing by standard RT-PCR assay or equivalent testing * No AIDS Symptoms * No clinical signs indicative of Severe or Critical Illness Severity * Sign Informed Consent Form Exclusion Criteria: * Severe or Critical Illness Severity * Pregnancy * Breast-feeding * The patients with other serious inter-current illness * Serious Allergy * Serious Bleed or Clot Tendency * Serious side-effects of the biological product * The prohibition of the biological product

What they're measuring

Number of HIV (+) Participants:

Timeframe: Duration up to 4 weeks

Rate of Positive HIV nucleic acid:

Timeframe: Duration up to 4 weeks

Rate of Negative HIV nucleic acid:

Timeframe: Duration up to 4 weeks

20 HIV (+) Participants with IGRA blood test with HIV antigens

Timeframe: Duration up to 4 weeks

20 HIV (+) Participants with IGRA blood test with TB antigens

Timeframe: Duration up to 4 weeks

Trial details

NCT IDNCT07182838

SponsorHan Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-08-18

View on ClinicalTrials.gov More HIV Infections trials

Plain-language summary

Who can participate

Age range24 Years – 64 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of HIV (+) Participants:

Timeframe: Duration up to 4 weeks

Rate of Positive HIV nucleic acid:

Timeframe: Duration up to 4 weeks

Rate of Negative HIV nucleic acid:

Timeframe: Duration up to 4 weeks

20 HIV (+) Participants with IGRA blood test with HIV antigens

Timeframe: Duration up to 4 weeks

20 HIV (+) Participants with IGRA blood test with TB antigens

Timeframe: Duration up to 4 weeks