NCT00002120已完成1 期
Randomized Phase I Study of Trimetrexate Glucuronate (TMTX) With Leucovorin (LCV) Protection Plus Dapsone Versus Trimethoprim / Sulfamethoxazole (TMP/SMX) for Treatment of Moderately Severe Episodes of Pneumocystis Carinii Pneumonia
U.S. Bioscience2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2001年8月31日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
研究概览
简要总结
To evaluate the safety of the combination of trimetrexate glucuronate (TMTX) and dapsone with leucovorin protection versus trimethoprim/sulfamethoxazole (TMP/SMX) in patients with AIDS and moderately severe Pneumocystis carinii pneumonia (PCP). To determine the pharmacokinetic parameters of TMTX, leucovorin, and dapsone and of TMP/SMX when given to patients with AIDS and moderately severe PCP.
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:
- •Empiric therapy for other opportunistic pulmonary infection (TB or fungi) for the first 72 hours of study enrollment ONLY, until presence of suspected pathogens can be confidently excluded.
- •Patients must have:
- •Confirmed diagnosis of PCP.
- •Alveolar-arterial differences in dissolved oxygen >= 35 mm Hg but < 55 mm Hg on room air.
排除标准
- •Co-existing Condition:
- •Patients with the following symptoms or conditions are excluded:
- •Severe renal or hepatic dysfunction.
- •Serious or life-threatening intolerance to TMP/SMX, TMTX, or dapsone.
- •Concurrent pneumothorax.
- •Active pulmonary tuberculosis or other inadequately treated opportunistic pulmonary infection (e.g., Cryptococcus neoforms, CMV). NOTE:
- •Identification of Mycobacterium avium or CMV in sputum or BAL fluid does not exclude, since these organisms may be present without causing disease.
- •Pulmonary Kaposi's sarcoma.
- •Active opportunistic infections or malignancies requiring induction therapy with bone marrow suppressive drugs (e.g., ganciclovir) or hepatotoxic drugs (e.g., chemotherapy).
- •Unable to have arterial blood gases on room air obtained at baseline.
- •Unwilling to undergo bronchoscopy, if sputum induction does not reveal Pneumocystis carinii.
- •Suspected malabsorption (e.g., ileus or severe diarrhea with > 6 stools/day).
- •Known absence of G6PD activity.
- •Large volume (1.0 to 1.5 liters) of intravenous fluid (5 percent in water) per 24 hours is medically inadvisable.
- •Unwilling to comply with study design.
- •Concurrent Medication:
- •Induction therapy with bone marrow suppressive drugs (e.g., ganciclovir) or hepatotoxic drugs (e.g., chemotherapy).
- •AZT, ddI, ddC, d4T, or other antiretroviral therapy.
- •Patients with the following prior condition are excluded:
- •Prior history of serious or life-threatening intolerance to TMP/SMX. (NOTE:
- •Patients with less severe reactions may be included at the discretion of the investigator and primary care provider.)
- •Prior Medication:
- •More than 24 hours of systemic anti-PCP therapy within 2 weeks prior to study entry.
研究者
研究点 (2)
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