ACTG 254--ATOVAQUONE & AZITHROMYCIN COMPARED TO TRIMETHOPRIM-SULFAMETHOXAZOLE

ACTG 254--阿托伐醌

• 批准号: 6282683
• 负责人: Peter James Krause
• 金额: $ 1.85万
• 依托单位: UNIVERSITY OF CONNECTICUT SCH OF MED/DNT
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-12-01 至 1998-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6282683
• 关键词: AIDS therapy; Pneumocystis carinii; Pneumocystis pneumonia; adolescence (12-20); atovaquone; azithromycin; child (0-11); clinical research; combination chemotherapy; drug adverse effect; drug screening /evaluation; drug tolerance; human subject; human therapy evaluation; longitudinal human study; microorganism disease chemotherapy; naphthoquinones; pediatric AIDS; pediatric pharmacology; sulfamethoxazole; trimethoprim

Six hundred eighty HIV-infected infants and children aged 2 to 19 years who require Pneumocystis carinii pneumonia (PCP) prophylaxis will be enrolled in this study nationwide. Subjects will be randomized to one of two arms, trimethoprim-sulfamethoxazole (TMP/SMX) or atovaquone plus azithromycin. Subjects will be evaluated for safety and tolerance of the study drugs. Cross-over to alternative study drug regimen will occur for either arm if a serious treatment-related toxicity or serious bacterial infection endpoint is observed. Patients will be followed for two years. Intensive monitoring of subjects will occur for the first 6 months, during which time the subjects will be monitored on a regular basis for adverse events. The primary objectives of this study are 1) to determine the comparability of azithromycin plus atovaquone to TMP/SMX in the prevention of serious bacterial infections; and, 2) to determine and compare the long-term safety and tolerance of atovaquone plus azithromycin versus TMP/SMX. Subjects currently enrolled will be seen on three month intervals until this study is closed. Enrollment of 3-4 more subjects is anticipated.

680名感染艾滋病毒的婴儿和2至19岁的儿童 需要卡氏肺孢子虫肺炎（PCP）预防的患者， 在全国范围内参加了这项研究。 受试者将被随机分配至 两组，甲氧苄啶-磺胺甲恶唑（TMP/SMX）或阿托伐醌加 阿奇霉素 将评估受试者的安全性和耐受性 研究药物。 交叉至替代研究药物方案将 如果发生严重治疗相关毒性或严重 观察细菌感染终点。 将对患者进行随访， 两年 将对受试者进行强化监测， 6个月，在此期间，将定期监测受试者 不良事件的依据。本研究的主要目的是1） 确定阿奇霉素加阿托伐醌与 TMP/SMX预防严重细菌感染;以及，2） 确定和比较阿托伐醌的长期安全性和耐受性 联合阿奇霉素与TMP/SMX的比较。目前入组的受试者将 每隔三个月观察一次，直到本研究结束。 招生 预计将增加3-4名受试者。