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NCT Number: 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 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

HIV Infections Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

24 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Medicine Invention Design Incorporation - IORG0007849 - NPI 1023387701

Rockville, Maryland, 20853, United States

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

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

Biological
  • By the percutaneous route with the multiple puncture device
  • HIV GP160 0.1 mg x 1 mL plus BCG Organism 50 MG Mix

Other names: GP160 plus BCG Vaccine Mix

Primary outcomes

  1. Number of HIV (+) Participants:

    Time frame: Duration up to 4 weeks

    • 20 HIV (+) patients
    • Positive HIV testing by standard RT-PCR assay
    • No AIDS Symptoms
    • No clinical signs indicative of Severe or Critical Illness Severity

  2. Rate of Positive HIV nucleic acid:

    Time frame: Duration up to 4 weeks

    • 20 HIV (+) patients
    • Positive HIV testing by standard RT-PCR assay immediately
    • HIV nucleic acid testing, assessed by RT-PCR Assay Kit
    • Rate of Positive HIV nucleic acid must be 100%

  3. Rate of Negative HIV nucleic acid:

    Time frame: Duration up to 4 weeks

    • 20 HIV (+) patients
    • 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 by standard RT-PCR assay after percutaneous use 3 weeks
    • HIV nucleic acid testing, assessed by RT-PCR Assay Kit
    • Rate of Negative HIV nucleic acid will be more than 70%

  4. 20 HIV (+) Participants with IGRA blood test with HIV antigens

    Time frame: Duration up to 4 weeks

    • Positive IGRA blood test with HIV GP160 antigen after percutaneous use 3 weeks

  5. 20 HIV (+) Participants with IGRA blood test with TB antigens

    Time frame: Duration up to 4 weeks

    • Negative IGRA blood test with TB antigens before percutaneous use
    • Positive IGRA blood test with TB antigens after percutaneous use 3 weeks

Sponsors and collaborators

Lead sponsor

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

Industry

Collaborators

  • UnitedHealthcare

Registry information

Official study title

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

Acronym: HIVGP-BCG

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 19, 2025
Registry last updated
Oct 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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