REMUNE + AMPLIVAX IR103 HIV/AIDS Phase III Safety & Efficacy Study
试验速览
- 阶段
- 3 期
- 入组人数
- 500
- 试验地点
- 1
- 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 changes in the Remune + Amplivax group vs the Amplivax placebo groups. Additional objectives include changes in WBC White Blood Cell counts & CD4+ & CD8+ T cell counts along with increased HIV immunity.
详细描述
This is a 500 subject Multi Center double-blind randomized, Safety & Efficacy, HIV/AIDS Phase III study, to primarily to evaluate the safety and efficacy of HIV-1 immunogen & Amplivax compared to placebo group Amplivax in viral load, and secondarily to examine changes in CD4+ & CD8+ T cell counts, determine Remune vaccines effect of multiple inoculations of HIV-1 immunogen + Amplivax on viral replication in adults with HIV-1 infection & to examine immunogenicity of Remune + Amplivax in a Multi-center, randomized , double-blind, placebo-controlled, two arm parallel design study of Remune + Amplivax.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Are HIV-positive and started anti-HIV drugs soon after tests showed the presence of HIV.
- •Are at least 16 years old (consent of parent or guardian required if under 18 years).
排除标准
- •Healthy Subjects
- •Currently abuse alcohol or drugs.
研究组 & 干预措施
AMPLIVAX 1.0 + IFA
AMPLIVAX 1.0 mg Amplivax™ (HYB2055) Adjuvant (1.0 mg) + IFA Incomplete Freund's Adjuvant (the same adjuvant and in the same ratio that is used in REMUNE).
干预措施: IR103 (Biological)
IR103 REMUNE + AMPLIVAX 1.0
IR103 Vaccine contain the same active component as REMUNE® (Inactivated HIV-1 Antigen Drug Substance at 10 μg/mL p24 dose), and have one dose of Amplivax™ (HYB2055) Adjuvant (1.0 mg) added before emulsification in Incomplete Freund's Adjuvant (the same adjuvant and in the same ratio that is used in REMUNE).
干预措施: IR103 (Biological)
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 at Week 52
次要结局
- The secondary objective is to evaluate & compare changes in WBC White Blood Cell counts between the treatment groups(52 Weeks)
- The secondary objective is to evaluate & compare changes in CD4+ & CD8+ T cell counts between the treatment groups(52 Weeks)