NCT00002240已完成2 期
Evaluation of the Safety and Antiviral Efficacy of a Novel HIV-1 Protease Inhibitor, BMS-232632, Alone and in Combination With d4T and ddI as Compared to a Reference Combination Regimen
Bristol-Myers Squibb17 个研究点 分布在 2 个国家开始时间: 1999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
- 试验地点
- 17
研究概览
简要总结
The purpose of this study is to evaluate a new protease inhibitor known as BMS-232632. This drug will be given in combination with 2 other anti-HIV drugs (stavudine and didanosine). The effectiveness of BMS-232632 against HIV infection will be compared to that of nelfinavir, a protease inhibitor that is already commonly prescribed.
详细描述
Patients are randomized to receive one of two drug regimens: BMS-232632, ddI, and d4T or NFV, ddI, and d4T. Three different doses of BMS-232632 are used in this study. Randomization is stratified for HIV RNA level (less than 30,000 copies/ml versus 30,000 or greater copies/ml). Patients remain on their drug regimen for 48 weeks.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
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
- •Patients may be eligible for this study if they:
- •Are HIV-positive.
- •Have an HIV blood level between 2,000 and 200,000 copies/ml.
- •Have a CD4 cell count of at least 100 cells/mm
- •Are 18 years of age or older.
- •Are available for follow-up for at least 48 weeks.
- •Agree to use a barrier method of birth control (such as condoms) during the study.
排除标准
- •Patients will not be eligible for this study if they:
- •Have ever received anti-HIV (antiretroviral) treatment.
- •Have an HIV-related opportunistic infection or condition at the time of study entry.
- •Have primary HIV infection, meaning they have recently been infected.
- •Have had severe diarrhea within the 30 days before study entry.
- •Have hemophilia.
- •Have a history of pancreatitis, hepatitis, or a peripheral neuropathy.
- •Are unable to tolerate oral medication.
- •Are pregnant or breast-feeding.
- •Abuse alcohol or drugs.
研究者
研究点 (17)
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