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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-12

Study Completion Date

2026-10-28

Brief Summary

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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.

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Detailed Description

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* 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.

Conditions

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HIV Infections

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single Usage / Single Dosage

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Open Label

Study Groups

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

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

Group Type EXPERIMENTAL

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

Intervention Type BIOLOGICAL

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

Interventions

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

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

Intervention Type BIOLOGICAL

Other Intervention Names

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GP160 plus BCG Vaccine Mix

Eligibility Criteria

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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

Minimum Eligible Age

24 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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

M.D., Ph.D., FAPCR, Sponsor-Investigator, Medical Director, IORG Director, Medical Monitor, Safety Officer, IRB Chair

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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HAN XU, MD/PhD/FAPCR

Role: STUDY_CHAIR

Medicine Invention Design Incorporation - IRB00009424

HAN XU, MD/PhD/FAPCR

Role: STUDY_DIRECTOR

Medicine Invention Design Incorporation - IORG0007849

HAN XU, MD/PhD/FAPCR

Role: PRINCIPAL_INVESTIGATOR

Medicine Invention Design Incorporation - NPI 1023387701

Locations

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Medicine Invention Design Incorporation - IORG0007849 - NPI 1023387701

Rockville, Maryland, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND

PMID: 27102489 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 32132681 (View on PubMed)

Provided Documents

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