NCT00013897已完成3 期
A Phase III Study Comparing the Antiviral Efficacy and Safety of BMS-232632 With Efavirenz; Each in Combination With Fixed Dose Zidovudine-Lamivudine
Bristol-Myers Squibb99 个研究点 分布在 16 个国家开始时间: 2001年2月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 试验地点
- 99
研究概览
简要总结
The purpose of this study is to compare the effectiveness of treatment with BMS-232632 to that of efavirenz (EFV) when both are used with zidovudine (ZDV) and lamivudine (3TC).
详细描述
This is a multinational, 2-arm study. Patients in 1 arm receive BMS-232632 plus EFV placebo capsules. Patients in the other arm receive EFV plus BMS-232632 placebo. Both arms also receive a fixed dose of ZDV-3TC.
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
- 16 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 a viral load of 2,000 or more copies/ml and a CD4 cell count of 100 or more cells/mm3 (or 75 or more cells/mm3 with no prior history of AIDS-defining diagnosis) within 2 weeks before randomization.
- •Are at least 16 years old.
- •Have signed consent of parent or guardian if under 18 years of age.
- •Are willing to use effective barrier methods of birth control.
- •Are available for follow-up for at least 52 weeks.
排除标准
- •Patients will not be eligible for this study if they:
- •Have had anti-HIV treatment within 30 days before screening.
- •Have a recently diagnosed HIV-related infection.
- •Have any medical condition requiring treatment at enrollment.
- •Have recently become HIV infected.
- •Have acute hepatitis within 30 days of study entry. Certain patients with chronic hepatitis will be eligible.
- •Expect to need or have taken drugs with myelosuppressive, neurotoxic, pancreatotoxic, hepatotoxic, or cytotoxic potential within 3 months before study. Expect to need methadone, ribavirin/interferons, neurotoxic drugs or drugs that affect CYP3A
- •Abuse alcohol or drugs.
- •Have severe diarrhea within 30 days before study entry.
- •Are pregnant or breast-feeding.
- •Have a history of hemophilia.
- •Have a history of bilateral peripheral neuropathy.
- •Cannot take medicines by mouth.
- •Have any other conditions that the doctor thinks would interfere with the study.
研究者
研究点 (99)
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