REMUNE HIV/AIDS Vaccine Phase II Pediatric Safety & Efficacy Clinical Study
试验速览
- 阶段
- 2 期
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- The primary objective is to compare & evaluate between the treatment groups the changes in HIV viral load at Week 52
研究概览
简要总结
The primary objective is to compare & evaluate between the treatment groups the changes in decline/reduction of HIV viral load & increase changes in WBC white blood cell counts in the adult Remune dose vs the low dose Remune placebo groups. Additional objectives include changes in CD4+ & CD8+ T cell counts along with increased HIV immunity.
详细描述
This is a 26 subject Multi Center double-blind randomized, Safety & Efficacy, pediatric HIV/AIDS Phase II study, to primarily to evaluate the safety and efficacy of HIV-1 immunogen and secondarily to examine changes in CD4+ & CD8+ T cell counts, determine Remune vaccines effect of multiple inoculations of HIV-1 immunogen on viral replication in children with HIV-1 infection & immunogenicity of Remune. Multi-center, randomized , double-blind, placebo-controlled, two arm parallel design study of Remune.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 3 Months 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children clinically diagnosed with HIV that are 3 months of age to the age 16 years old
- •Subjects on any approved FDA antiviral medication except triple cocktail HAART drugs
排除标准
- •Triple cocktail HAART drugs
- •Healthy subjects
结局指标
主要结局
The primary objective is to compare & evaluate between the treatment groups the changes in HIV viral load at Week 52
时间窗: 52 Weeks
The primary objective is to compare \& evaluate between the treatment groups the changes in HIV viral load (HIV RNA Viral Load) at Week 52
The primary objective is to compare & evaluate between the treatment groups the changes in WBC white blood cell counts at Week 52
时间窗: 52 Weeks
The primary objective is to compare \& evaluate between the treatment groups the changes in WBC white blood cell counts at Week 52
次要结局
- The secondary objective is to evaluate & compare between the treatment groups to induce immune responses between adult and low doses of REMUNE(52 Weeks)
- The secondary objective is to evaluate & compare changes in CD4+ & CD8+ T cell counts between the treatment groups(52)
- The secondary objective is to evaluate & compare the effect of multiple inoculations of HIV-1 immunogen on viral replication in children with HIV-1 infection(52 Weeks)