NCT00002322已完成2 期
Randomized, Double-Blind, Placebo-Controlled Comparative Dose-Response Study of Two Doses of Atevirdine Mesylate (U-87201E) in Combination With Fixed Doses of Zidovudine (AZT) in HIV+ Patients
Pharmacia and Upjohn12 个研究点 分布在 1 个国家开始时间: 2001年8月31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
- 12
研究概览
简要总结
To determine the tolerance and antiviral response of two different doses of atevirdine mesylate (U-87201E) in symptomatic HIV-positive patients with CD4 counts of 50-350 cells/mm3, who also take zidovudine (AZT).
详细描述
Patients are randomized to 1 of 3 treatment groups: U-87201E at 1 of 2 doses or placebo administered every 8 hours. Patients must have taken AZT for at least 3 months prior to randomization.
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
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Concurrent Medication:
- •Primary or secondary prophylaxis for opportunistic infections.
- •Patients must have:
- •HIV infection.
- •Symptoms (currently or prior to enrollment) included in Category B or C of CDC classification, although THE FOLLOWING CURRENT ACUTE MEDICAL CONDITIONS ARE NOT ALLOWED:
- •Cryptococcosis
- •Pneumocystis carinii pneumonia
- •Herpes zoster
- •Histoplasmosis
- •Hepatic or renal disease
- •Lymphoma.
- •CD4 count 50 - 350 cells/mm3 within 14 days prior to study entry.
- •Ongoing therapy with AZT at 500 - 600 mg total daily dose for at least 3 months prior to study entry.
- •Consent of parent, guardian, or person with power of attorney if less than 18 years of age.
排除标准
- •Co-existing Condition:
- •Patients with the following conditions are excluded:
- •Intolerance to AZT.
- •Current diagnosis of malignancy for which systemic therapy will be required during the study.
- •Concurrent Medication:
- •Any other investigational drugs.
- •Prior Medication:
- •Cytotoxic chemotherapy within 1 month prior to study entry.
- •Prior U-87201E or any other non-nucleoside antiretroviral medications, including but not limited to nevirapine, TIBO R-82150 or TIBO R-82913, L-697639 or L-696229, U-90152S, or any protease inhibitors.
- •Antiretroviral agents other than AZT within 3 months prior to study entry.
- •AZT for at least 3 months prior to study entry. Present use of excessive alcohol or illicit drugs.
研究者
研究点 (12)
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