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.
* 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
20
* By the percutaneous route with the multiple puncture device * HIV GP160 0.1 mg x 1 mL plus BCG Organism 50 MG Mix
Medicine Invention Design Incorporation - IORG0007849 - NPI 1023387701
Rockville, Maryland, United States
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
Time frame: 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%
Time frame: 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%
Time frame: 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
Time frame: 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
Time frame: Duration up to 4 weeks
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