NCT00002056已完成不适用
A Controlled Trial Comparing the Efficacy of Aerosolized Pentamidine and Parenteral / Oral Trimethoprim - Sulfamethoxazole in the Treatment of Pneumocystis Carinii Pneumonia in AIDS
LyphoMed2 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
- 不适用
- 状态
- 已完成
- 发起方
- 试验地点
- 2
研究概览
简要总结
This is a randomized double-blinded controlled study comparing aerosolized pentamidine with trimethoprim plus sulfamethoxazole (TMP / PurposeX). The latter drug will be administered intravenously for at least 5 days, then changed to oral administration if warranted by the patient's clinical condition.
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:
- •Zidovudine as long as such therapy is suspended prior to randomization and not reinstituted until therapy for the acute episode is completed.
- •Pneumocystis carinii pneumonia (PCP) in an adult who is HIV positive by ELISA, HIV culture, or p24 antigenemia, or is a member of a risk group for HIV infection (homosexual or bisexual men, intravenous drug abusers, recipients of HIV infected blood products, and the sexual partners of the foregoing groups).
- •The patient must have a resting Alveolar - arterial oxygen (A-a) DO2 less than 30 mmHg on room air at all ACTG sites, except San Francisco General Hospital. Other sites will enter patients up to a resting (A-a) DO2 = or < 55 mmHg on room air.
- •Prior Medication:
- •Zidovudine as long as such therapy is suspended prior to randomization and not reinstituted until therapy for the acute episode is completed.
排除标准
- •Co-existing Condition:
- •Patients with the following are excluded:
- •Bronchospasm.
- •History of a major adverse reaction to pentamidine or sulfonamide containing preparations.
- •Patients with the following will be excluded:
- •Inability to cooperate with aerosol administration because of dyspnea, cough, bronchospasm, or other reasons.
- •History of a major adverse reaction to pentamidine or sulfonamide containing preparations.
- •In the opinion of the investigator, the patient would not complete therapy or follow-up for social reasons.
- •Prior Medication:
- •Excluded within 14 days of study entry:
- •Systemic steroids above adrenal replacement doses.
- •Excluded within 6 weeks of study entry:
- •Other antiprotozoal regimen for this episode such as trimethoprim / sulfamethoxazole (TMP / PurposeX).
- •Pyrimethamine.
- •Fansidar.
- •Pentamidine.
- •Eflornithine (DFMO).
- •Dapsone, whether therapeutic or prophylactic, or any of these agents.
研究者
研究点 (2)
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