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

NCT07182838 | Active Not Recruiting Early Phase 1 DMC FDA Drug

• 7 other identifiers: IND 179135 ResearchFWA00015357IRB00009424IORG0007849NPI-1831468511NPI-1023387701IND 179135
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 1.Treat Infection of Multiple Gene Mutation HIV Virus Strains.
2. 2.Activate Human Antigen Presentation Reaction to HIV Specific Antigen.
3. 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.

Conditions

HIV Infections

Keywords

HIV; AIDS; GP160; BCG

Outcome Measures

Primary Outcomes (5)

• Number of HIV (+) Participants:

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

  Duration up to 4 weeks

• Rate of Positive HIV nucleic acid:

  * 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%

  Duration up to 4 weeks

• Rate of Negative HIV nucleic acid:

  * 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%

  Duration up to 4 weeks

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

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

  Duration up to 4 weeks

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

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

  Duration up to 4 weeks

Study Arms (1)

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

EXPERIMENTAL

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

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

Interventions

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

Also known as: GP160 plus BCG Vaccine Mix

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

Eligibility Criteria

• Age: 24 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair: lead
• UnitedHealthcare: collaborator

Study Sites (1)

Medicine Invention Design Incorporation - IORG0007849 - NPI 1023387701

Rockville, Maryland, 20853, United States

Location

Related Publications (2)

• Netea MG, Joosten LA, Latz E, Mills KH, Natoli G, Stunnenberg HG, O'Neill LA, Xavier RJ. Trained immunity: A program of innate immune memory in health and disease. Science. 2016 Apr 22;352(6284):aaf1098. doi: 10.1126/science.aaf1098. Epub 2016 Apr 21.

  PMID: 27102489 BACKGROUND

• Netea MG, Dominguez-Andres J, Barreiro LB, Chavakis T, Divangahi M, Fuchs E, Joosten LAB, van der Meer JWM, Mhlanga MM, Mulder WJM, Riksen NP, Schlitzer A, Schultze JL, Stabell Benn C, Sun JC, Xavier RJ, Latz E. Defining trained immunity and its role in health and disease. Nat Rev Immunol. 2020 Jun;20(6):375-388. doi: 10.1038/s41577-020-0285-6. Epub 2020 Mar 4.

  PMID: 32132681 BACKGROUND

Related Links

• FWA00015357
• IRB00009424
• IORG0007849

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

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

Study Officials

• HAN XU, MD/PhD/FAPCR

  Medicine Invention Design Incorporation - IRB00009424

  STUDY CHAIR

• HAN XU, MD/PhD/FAPCR

  Medicine Invention Design Incorporation - IORG0007849

  STUDY DIRECTOR

• HAN XU, MD/PhD/FAPCR

  Medicine Invention Design Incorporation - NPI 1023387701

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: Open Label
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: M.D., Ph.D., FAPCR, Sponsor-Investigator, Medical Director, IORG Director, Medical Monitor, Safety Officer, IRB Chair

Model Details: Single Usage / Single Dosage

Study Record Dates

• First Submitted: September 12, 2025
• First Posted: September 19, 2025
• Study Start: September 12, 2025
• Primary Completion (Estimated): August 18, 2026
• Study Completion (Estimated): October 28, 2026
• Last Updated: October 7, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)