NCT00005012已完成2 期
Antiviral Activity and Tolerability of PEG-Intron in HIV-Infected Subjects Failing HAART
Schering-Plough43 个研究点 分布在 2 个国家目标入组 250 人开始时间: 2000年3月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 250
- 试验地点
- 43
研究概览
简要总结
The purpose of this study is to see if it is effective to give PEG-Intron (PEG-IFN) to HIV-infected patients who are not doing well with their current anti-HIV drug combination (HAART).
详细描述
At entry, patients undergo HIV genotypic/phenotypic analysis. Patients continue their current antiretroviral regimen but are randomized to receive one of four doses of PEG-IFN or PEG-IFN placebo administered subcutaneously once per week until results of HIV genotyping/phenotyping are available (approximately 4 weeks). Patients who respond with a 0.5 log or greater decrease in HIV RNA at Week 4 have optimized HAART added to their ongoing PEG-IFN regimen and are followed for 24 weeks in an observational study.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 0 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients may be eligible for this study if they:
- •Have HIV levels of more than 2000 copies/ml.
- •Have failed their current HAART (had a significant increase in their HIV levels with HAART).
- •Have a CD4 cell count greater than 200 cells/microL.
- •Have had more than 6 months of HAART.
- •Have been on their current HAART for at least 6 weeks.
- •Agree to use an effective method of birth control during the study.
排除标准
- •Patients will not be eligible for this study if they:
- •Have a history of a serious mental disorder.
- •Are allergic to interferons.
- •Are pregnant or breast-feeding.
- •Are taking certain medications such as ribavirin, hydroxyurea, and ganciclovir.
研究者
研究点 (43)
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