NCT00002359已完成3 期
A Multicenter, Double-Blind, Phase III, Adjuvant-Controlled Study of the Effect of 10 Units of HIV-1 Immunogen (Remune) Compared to Incomplete Freund's Adjuvant (IFA) Alone Every 12 Weeks on AIDS-Free Survival in Subjects With HIV Infection and CD4 T-Lymphocytes Between 300 and 549 Cells/microL Regardless of Concomitant HIV Therapies
The Immune Response Corporation54 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2001年8月31日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 3,000
- 试验地点
- 54
研究概览
简要总结
To determine the effect of HIV-1 immunogen (Remune) on AIDS-free survival, defined as the time prior to development of an AIDS-defining condition or death.
详细描述
Patients receive 10 units of HIV-1 immunogen in IFA or IFA alone every 12 weeks, then are followed for 104-148 weeks.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Concurrent Medication:
- •Antiretrovirals if on a stable dose for at least the past 3 months.
- •Patients must have:
- •HIV-1 infection with CD4 count 300-549 cells/mm
- •No AIDS-defining condition.
- •Been on a stable dose of antiretroviral for the past 3 months, if taking antiretrovirals.
- •KS is permitted if not requiring systemic therapy.
- •Prior Medication:
- •Prior antiretrovirals.
排除标准
- •Concurrent Medication:
- •Systemic chemotherapy for KS.
- •Treatment for malignancy other than basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
- •Patients with the following prior conditions are excluded:
- •History of any illness that would interfere with study.
- •Acute infection requiring prescription therapy within the past month, other than genital herpes and oral or vaginal candidiasis.
- •Prior Medication:
- •Prior HIV-1 Immunogen. Unwilling to use effective safe sex practices. Active substance abuse.
研究者
研究点 (54)
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