NCT00002020已完成不适用
Trial of an Alternative Dosing Regimen of Oral Retrovir in Patients With AIDS or Advanced ARC
Glaxo Wellcome24 个研究点 分布在 2 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
- 不适用
- 状态
- 已完成
- 发起方
- 试验地点
- 24
研究概览
简要总结
To evaluate the safety and tolerance, in patients with severe clinical manifestations of HIV infection, of zidovudine (AZT) administered daily for 48 weeks as a low dose every 4 hours or a higher dose every 12 hours.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
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:
- •- Prophylaxis or treatment for Pneumocystis carinii pneumonia (PCP) consisting of either trimethoprim / sulfamethoxazole, aerosolized pentamidine, pyrimethamine / sulfadoxine, or dapsone allowed at the discretion of the investigator.
- •Patients with the following are excluded:
- •Any immediately life-threatening infection or medical condition present at the time of study entry.
- •Any active opportunistic or other infection requiring chronic therapy at the time of study entry. Patients with PCP may be randomized to study medication following a minimum 7-day course of therapy resulting in stabilization of their disease. Patients with stabilized disease must have a fever < 39 C for at least 48 hours, pO2 (on room air ) = or > 60 mm, and an Arterial/alveolar gradient = or < 30 mm.
- •Diagnosis of AIDS Dementia Complex.
- •Received more than 4 weeks of antiretroviral therapy or who previously discontinued antiretroviral therapy due to drug related toxicity.
- •Diseases and conditions listed in Exclusion Co-existing Conditions.
- •Patients must have the following:
- •Seropositive for HIV infection documented by any federally licensed ELISA and confirmed by Western blot.
- •Advanced HIV disease or AIDS-related complex.
- •Ability to give informed consent.
排除标准
- •Co-existing Condition:
- •Patients with the following conditions or symptoms are excluded:
- •AIDS with malignant disease likely to require cytotoxic chemotherapy.
- •Diagnosis of AIDS Dementia Complex.
- •Impaired renal function ( Creatinine clearance < 50 ml/min/1.73m2 or serum creatinine = or > 2 mg/dl).
- •Impaired hepatic function ( ALT = or > 5 x upper limit of normal).
- •Fever > 39 C at entry.
- •Concurrent Medication:
- •Any other experimental therapy.
- •Drugs which cause significant bone marrow suppression.
- •Cytolytic chemotherapy.
- •Drugs which cause significant nephrotoxicity or hepatotoxicity.
- •Concurrent Treatment:
- •Radiation therapy (with the exception of electron beam therapy to an area < 100 cm2).
- •Prior Medication:
- •Excluded within 2 weeks of study entry:
- •- Any other experimental therapy. Drugs which cause significant bone marrow suppression. Cytolytic chemotherapy. Drugs which cause significant nephrotoxicity or hepatotoxicity.
- •Excluded within 4 weeks of entry:
- •- Immunomodulating agents, including pharmacological doses of steroids for more than 10 days (except for management of severe PCP in which case duration should not exceed 21 days). Interferon. Isoprinosine. IL-
- •Excluded within 8 weeks of entry:
- •Antiretroviral agents including:
- •- Ribavirin. Dideoxycytidine (ddC). Dideoxyadenosine (ddA). Didanosine (ddI). Foscarnet. Dextran Sulfate. AL-
- •Retrovir (Zidovudine, AZT) for greater than 4 weeks or within 90 days of study entry, or patients who originally discontinued Retrovir due to drug-related toxicity. Drugs metabolized by hepatic glucuronidation may alter the metabolism of Retrovir and should not be used chronically.
- •Prior Treatment:
- •Radiation therapy (with the exception of electron beam therapy to an area < 100 cm2) within 2 weeks of study entry.
- •Known active drug or alcohol abuse.
研究者
研究点 (24)
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