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
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Number of HIV (+) Participants:
Study Overview
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
- Treat Infection of Multiple Gene Mutation HIV Virus Strains.
- Activate Human Antigen Presentation Reaction to HIV Specific Antigen.
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Health Services Research
- Masking
- None
Masking Description
Open Label
Eligibility Criteria
- Ages
- 24 Years to 64 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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
Intervention: HIV Therapeutic Biologic Mix - HIV GP160 plus BCG Vaccine Mix for percutaneous use (Biological)
Outcomes
Primary Outcomes
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
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%
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%
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
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
Secondary Outcomes
No secondary outcomes reported
Investigators
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
Medicine Invention Design, Inc