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
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Number of HIV (+) Participants:
研究概览
简要总结
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.
详细描述
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
盲法说明
Open Label
入排标准
- 年龄范围
- 24 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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
干预措施: HIV Therapeutic Biologic Mix - HIV GP160 plus BCG Vaccine Mix for percutaneous use (Biological)
结局指标
主要结局
Number of HIV (+) Participants:
时间窗: 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:
时间窗: 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:
时间窗: 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
时间窗: 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
时间窗: 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
次要结局
未报告次要终点
研究者
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