NCT00002412已完成2 期
A Randomized, Double-Blind Study of MKC-442 Combined With Stavudine, Didanosine, and Hydroxyurea in HIV-Infected Patients Who Are Protease Inhibitor Experienced and Non-Nucleoside Reverse Transcriptase Inhibitor Naive
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 2
研究概览
简要总结
The purpose of this study is to see if it is safe and effective to give MKC-442 plus stavudine (d4T) plus didanosine (ddI) plus hydroxyurea.
详细描述
Patients are randomized to receive either MKC-442 or placebo, along with stavudine(d4T), didanosine(ddI), and hydroxyurea. Patients will be treated and followed for 48 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:
- •- Based on medical history, medical condition, prior use of antiretroviral drugs, and genotypic analysis of the predominant strain of HIV-1 isolated from the plasma, administration of a combination of two or more available antiretroviral agents by prescription may be given with MKC-
- •Patient must have:
- •HIV infection with HIV-1 RNA greater than or equal to 5,000 by Roche Amplicor method within 30 days of entry.
- •A failed protease inhibitor-containing regimen.
- •Negative serum beta human chorionic gonadotropin test within 30 days of entry.
- •Prior Medication:
- •Prior nucleoside reverse transcriptase and protease inhibitors.
- •Cytotoxic chemotherapy more than 30 days prior to entry.
排除标准
- •Co-existing Condition:
- •Patients with the following symptoms or conditions are excluded:
- •Malabsorption or severe chronic diarrhea within 30 days prior to entry, or inability to consume adequate oral intake because of chronic nausea, emesis, or abdominal or esophageal discomfort.
- •Inadequately controlled seizure disorder.
- •Known intolerance to stavudine, didanosine, and/or hydroxyurea.
- •Acute and clinically significant medical event within 30 days of screening.
- •Any clinical or laboratory abnormality greater than Grade 3 toxicity, with the exception of laboratory values given.
- •Concurrent Treatment:
- •- Any experimental antiretroviral therapy or immunomodulators directed against HIV-1, e.g., IL-4, cyclosporine steroids at doses greater than 40 mg/day.
- •Prior Medication:
- •- Non-nucleoside reverse transcriptase inhibitor therapy.
- •Prior Treatment:
- •Radiation therapy within 30 days of entry except to a local lesion.
- •Transfusion of blood or blood products within 21 days of screening.
- •Cytotoxic therapy within 3 months of study entry.
- •Risk Behavior:
- •Active substance abuse that may interfere with compliance or protocol evaluations.
研究者
研究点 (2)
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