HIV Infections
Conditions
Keywords
HIV, AIDS, GP160, BCG
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. 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.
Detailed 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.
Interventions
BIOLOGICALHIV 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
Sponsors
UnitedHealthcare
Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Masking description
Open Label
Intervention model description
Single Usage / Single Dosage
Eligibility
Sex/Gender
ALL
Age
24 Years to 64 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of HIV (+) Participants: | 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 |
| Rate of Positive HIV nucleic acid: | 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% |
| Rate of Negative HIV nucleic acid: | 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% |
| 20 HIV (+) Participants with IGRA blood test with HIV antigens | Duration up to 4 weeks | \- Positive IGRA blood test with HIV GP160 antigen after percutaneous use 3 weeks |
| 20 HIV (+) Participants with IGRA blood test with TB antigens | 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 |
Countries
United States
Outcome results
None listed