NCT00000741撤回3 期
A Controlled Randomized Trial to Study the Efficacy of Adjunctive Methylprednisolone for the Treatment of Pneumocystis Carinii Pneumonia (PCP) in Pediatric AIDS Patients
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 6
研究概览
简要总结
To determine the effect of methylprednisolone on respiratory failure in HIV-infected patients with presumed or confirmed pneumocystis carinii pneumonia who are stratified for presence or absence of respiratory failure at the time of randomization to the study.
详细描述
HIV-infected children are randomized to receive adjunctive therapy with intravenous methylprednisolone or placebo. Treatment is administered for 10 days. Primary antipneumocystis therapy with TMP/SMX or systemic pentamidine is selected by the individual investigator and given for 21 days. Patients are stratified at the time of randomization by the presence or absence of respiratory failure.
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
- 主要目的
- Treatment
入排标准
- 年龄范围
- 28 Days 至 2 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Concurrent Medication:
- •Recombinant erythropoietin and any FDA-approved cytokine for management of anemia.
- •Antiretroviral agents.
- •Patients must have:
- •Documented HIV infection.
- •No more than 36 hours of prior primary therapy for confirmed or presumed PCP.
- •Prior Medication:
- •Up to 35 hours of primary therapy for confirmed or presumed PCP.
排除标准
- •Co-existing Condition:
- •Patients with the following symptoms and conditions are excluded:
- •Demonstrated intolerance to steroids.
- •Requirement for steroids at greater than physiological doses for other medical conditions.
研究者
研究点 (6)
Loading locations...
相似试验
已完成
2 期
Progression of HIV-Disease Under Low Dose CorticosteroidsHIV Disease ProgressionNCT01299948Medical Mission Institute, Germany326
已完成
2 期
The Effects of Prednisone on HIV Levels and the Immune SystemHIV InfectionsNCT00000921National Institute of Allergy and Infectious Diseases (NIAID)118
已完成
1 期
Administration of Methylprednisolone for Prevention of Ovarian Hyper Stimulation SyndromeOvarian Hyperstimulation SyndromeNCT01014104Royan Institute218
已完成
2 期
A Phase II Randomized, Double-Blind, Placebo-Controlled Trial to Determine the Efficacy of Prednisone Therapy in HIV-Associated Nephropathy (HIVAN)AIDS-Associated NephropathyHIV InfectionsNCT00000819National Institute of Allergy and Infectious Diseases (NIAID)54
撤回
2 期
Preventing Frequent Sinus Infections in HIV-Infected PatientsSinusitisHIV InfectionsNCT00000752National Institute of Allergy and Infectious Diseases (NIAID)