NCT00002235已完成2 期
A Phase II, 48-Week, Open-Label Study Designed to Evaluate the Safety, Tolerability, and Efficacy of a Simplified Dosing Regimen of Viracept (Nelfinavir Mesylate) 1250 Mg BID, Crixivan (Indinavir Sulfate) 1200mg q12h, and Sustiva (Efavirenz; DMP-266) 600 Mg q24h for the Treatment of HIV-1 Infection in Non-Nucleoside Reverse Transcriptase Inhibitor and Protease Inhibitor Naive Patients
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 5
研究概览
简要总结
Indinavir is usually taken three times a day. The purpose of this study is to see if it is safe and effective to take indinavir only twice a day plus nelfinavir (also taken twice a day) and efavirenz (taken once a day).
详细描述
Patients receive a treatment regimen consisting of nelfinavir, indinavir, and efavirenz for 48 weeks. During the study, patients are evaluated for changes from baseline in plasma HIV-1 RNA levels and lymphocyte subsets and for development of adverse events and toxicities. After Week 48, patients with documented virologic response are eligible to continue receiving study treatments and to attend scheduled follow-up visits. Patients who experience virologic failure are discontinued from the study.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •You may be eligible for this study if you:
- •Are HIV-positive.
- •Are at least 13 years old (consent of parent or guardian required if under 18).
- •Have a viral load of at least 10,000 copies/ml within 30 days of study entry.
- •Agree to use a barrier method of birth control, such as condoms, during the study.
排除标准
- •You will not be eligible for this study if you:
- •Have hepatitis.
- •Have any other serious medical condition besides HIV infection.
- •Are allergic to indinavir, nelfinavir, or efavirenz.
- •Have ever taken NNRTIs or protease inhibitors.
- •Have had chemotherapy or radiation therapy within 30 days of study entry. (Local radiation therapy is allowed.)
- •Have taken certain other medications that might affect your immune system such as interleukin-2, interferon, or a vaccine within 30 days of study entry.
- •Are enrolled or plan to enroll in another anti-HIV drug study during this study.
- •Are pregnant or breast-feeding.
- •Abuse alcohol or drugs.
研究者
研究点 (5)
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