NCT00002047已完成不适用
Retrovir Capsules in the Treatment of HIV-Infected Patients in Renal Failure
Glaxo Wellcome2 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:
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相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 试验地点
- 2
研究概览
简要总结
To evaluate the safety, tolerance, and pharmacokinetics of Retrovir (AZT) administration in HIV-infected patients in renal failure receiving maintenance hemodialysis.
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 must have:
- •A positive HIV antibody test (ELISA confirmed by Western blot).
- •Chronic renal failure managed by a stable hemodialysis regimen.
- •Acceptable hepatic function defined by specified lab values.
- •Life expectancy > 6 months.
- •Enrollment is limited to 9 chronic hemodialysis patients and 9 Continuous Ambulatory Peritoneal Dialysis (CAPD) patients. These patients must be stable in their ESRD treatment regimen before entry.
排除标准
- •Co-existing Condition:
- •Patients with the following are excluded:
- •Active, serious opportunistic infections at the time of study entry.
- •Fever > 100 degrees F at study entry.
- •Severe malabsorption (evidenced by persistent diarrhea of greater than 4 weeks duration with = or > 6 loose stools per day accompanied by significant weight loss).
- •Patients with the following are excluded:
- •Active, serious opportunistic infections at the time of study entry.
- •Fever > 100 degrees F at study entry.
- •Severe malabsorption (evidenced by persistent diarrhea of greater than 4 weeks duration with = or > 6 loose stools per day accompanied by significant weight loss).
- •Prior Medication:
- •Excluded within 2 weeks of study entry:
- •- Any other experimental therapy. Drugs which cause significant bone marrow suppression. Rifampin or rifampin derivatives. Cytolytic chemotherapy. Drugs which cause significant hepatotoxicity.
- •Excluded within 4 weeks of study entry:
- •- Immunomodulating agents, including steroids, interferon, Isoprinosine, and interleukin
- •Excluded within 8 weeks of study entry:
- •- Other antiretroviral agents (e.g., zidovudine [AZT], suramin, ribavirin, HPA-23, foscarnet, dextran sulfate, disulfiram, ddA/ddC, or dideoxycytidine).
- •Active drug or alcohol abuse.
研究者
研究点 (2)
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