Antiretroviral-Sparing Concept: An Exploratory Phase II, Randomized, Single Blind Placebo-Controlled Study to Investigate the Effect of Therapeutic Immunization on the Quantity of HIV-Specific T Cell Precursors During Highly Active Antiretroviral Therapy Followed by Analytical Treatment Interruption
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- HIV-specific memory T cells measured as PHPC count
研究概览
简要总结
PHPC-02 is a phase II, randomized, placebo-controlled trial designed to investigate whether therapeutic immunization during highly active antiretroviral therapy (HAART) induces elevations of HIV-specific T cell precursors with high proliferative capacity (PHPC) in HIV-1-infected individuals, and whether the quantity of PHPC correlates with the viral load set point following analytical treatment interruption (ATI). Subjects will be randomized to receive either DermaVir Patch (8 subjects per cohort) or DermaVir Patch Placebo (8 subjects per cohort) every four weeks for three applications while receiving maximally suppressive HAART. HAART will be discontinued at Week 9 for an ATI period of 20 weeks.
详细描述
16 subjects on maximally suppressive HAART were randomized to receive three doses of either DermaVir or Placebo immunotherapy.
Subjects receive three DermaVir/Placebo treatments over eight weeks (Weeks 0, 4 and 8) while receiving HAART. HAART is discontinued for a 20 week ATI.
Resumption of HAART during ATI is subjects experience:
- A confirmed CD4+ cell decrease by > 50%
- A confirmed CD4+ cell decrease to less than 350 counts/mL
- A confirmed VL increase > 300,000 copies
- Emergence of CDC AIDS related event(s)
- Signs or symptoms of clinically significant immunosuppression
- The subject or the subject's clinician wishes to restart HAART
- The subject becomes pregnant
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
DermaVir + HAART
- Dosage: 0.4 mg DNA
- Dosage form: 3.2 mL DNA/PEIm nanomedicine
- Administration with 4 DermaPrep patches
- Frequency: every 4 weeks
- Duration: 8 weeks (3 DermaVir treatments)
干预措施: DermaVir (Biological)
DermaVir + HAART
- Dosage: 0.4 mg DNA
- Dosage form: 3.2 mL DNA/PEIm nanomedicine
- Administration with 4 DermaPrep patches
- Frequency: every 4 weeks
- Duration: 8 weeks (3 DermaVir treatments)
干预措施: HAART (Drug)
Placebo + HAART
- Dosage form: 3.2 mL Placebo
- Administration with 4 DermaPrep patches
- Frequency: every four weeks
- Duration: 8 weeks (3 Placebo treatments)
干预措施: Placebo (Biological)
Placebo + HAART
- Dosage form: 3.2 mL Placebo
- Administration with 4 DermaPrep patches
- Frequency: every four weeks
- Duration: 8 weeks (3 Placebo treatments)
干预措施: HAART (Drug)
结局指标
主要结局
HIV-specific memory T cells measured as PHPC count
时间窗: 9 week
DermaVir-induced PHPC count compared to Placebo
次要结局
- HIV-1 RNA(weeks 16 and 20)
- CD4+ and CD8+ T cell counts(20 weeks)
- Adverse Events(20 weeks)