Proof-of-Concept Clinical Pharmacology Trial for HIV Antigen Presentation Therapeutic Biologic Mix (HIVGP-BCG)

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

Status and phase: Active, not recruiting; Early Phase 1

Conditions: HIV Infections

Treatments: Biological: HIV Therapeutic Biologic Mix - HIV GP160 plus BCG Vaccine Mix for percutaneous use

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07182838

NPI-1831468511 (Registry Identifier)

IRB00009424 (Registry Identifier)

IND 179135 (Registry Identifier)

IND 179135 Research

FWA00015357 (Registry Identifier)

NPI-1023387701 (Registry Identifier)

IORG0007849 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 24 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• 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

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Assess for therapeutic biologics activity (proof-of-concept)

Experimental group

Description:

Therapeutic Biological Product Mix activity - HIV GP160 0.1 mg x 1 mL add into BCG Organism 50 MG

Treatment:

Biological: HIV Therapeutic Biologic Mix - HIV GP160 plus BCG Vaccine Mix for percutaneous use