NCT00002030已完成不适用
An Open Label Study to Evaluate the Long-Term Safety and Effectiveness of Aerosol Pentamidine in the Prophylaxis of Pneumocystis Carinii Pneumonia in AIDS Patients
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Fisons
- 试验地点
- 2
研究概览
简要总结
To evaluate the safety, tolerability, and efficacy of long term, bi-weekly administration of aerosol pentamidine when used as a prophylactic agent in patients who have had at least two or more episodes of AIDS-associated Pneumocystis carinii pneumonia (PCP).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Concurrent Medication:
- •Zidovudine (AZT).
- •Standard or experimental treatments for an opportunistic infection or neoplasm (including aerosolized or intravenous pentamidine) that develops during the study.
- •Concurrent Treatment:
- •Any standard or experimental treatment for an opportunistic infection or neoplasm that develops during the study.
- •Patients must have AIDS with at least one cytologically or histologically proven episode of Pneumocystis carinii pneumonia (PCP).
- •Patients must be free of acute medical problems.
- •Prior Medication:
- •Zidovudine (AZT).
排除标准
- •Co-existing Condition:
- •Patients with the following conditions or symptoms are excluded:
- •Requiring ongoing active therapy for an opportunistic infection at the time of study entry.
- •Toxoplasmosis.
- •Cryptococcus.
- •Pulmonary Kaposi's sarcoma (KS).
- •Asthma poorly controlled by medication.
- •Concurrent Medication:
- •Pentamidine by any route other than aerosolized or intravenous or any other experimental agent for chemoprophylaxis of PCP while on the study (e.g.:
- •Septra, Fansidar, Dapsone, or eflornithine).
- •Concurrent Treatment:
- •Transfusion dependency defined as > 1 blood transfusion per month.
- •Patients with the following are excluded:
- •Requiring ongoing active therapy for an opportunistic infection (O.I.) at the time of entry or having either Toxoplasmosis or cryptococcosis at entry.
- •Pulmonary Kaposi's sarcoma (KS).
- •Active substance abuse by patients who cannot comply with study procedures.
- •Unwilling to sign informed consent.
- •In the opinion of the investigator cannot cooperate with study procedure.
- •Asthma poorly controlled by medication.
- •Patients may not receive pentamidine by any other route than aerosolized or intravenous or any other experimental agent for chemoprophylaxis of PCP while on the study (e.g.:
- •Septra, Fansidar, Dapsone, or eflornithine).
- •Prior Medication:
- •Excluded within 30 days of study entry:
- •Antiretroviral agents, excluding zidovudine (AZT).
- •Immunomodulating agents.
- •Corticosteroids.
- •Prior Treatment:
- •Excluded within 7 days of study entry:
- •Blood transfusion.
- •Excluded:
- •Requiring ongoing active treatments for an opportunistic infection at time of study entry.
- •Active substance abuse by patients who cannot comply with study procedures.
研究者
研究点 (2)
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