PENTAMIDINE FOR PNEUMOCYSTIS IN MEN, WOMEN, AND CHILDREN

喷他脒治疗男性、女性和儿童肺孢子虫病

• 批准号: 3140122
• 负责人: JOHN E CONTE
• 金额: $ 25.48万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 1989
• 资助国家: 美国
• 起止时间: 1989-07-01 至 1995-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3140122
• 关键词: AIDS; Pneumocystis carinii; Pneumocystis pneumonia; adult human (21+); age difference; blood chemistry; child (0-11); diagnostic respiratory lavage; disease /disorder prevention /control; drug adverse effect; female; gender difference; high performance liquid chromatography; human immunodeficiency virus 1; human subject; human therapy evaluation; inhalation drug administration; intravenous administration; male; mathematical model; opportunistic infections; pediatric AIDS; pentamidine; pharmacokinetics; respiratory disorder chemotherapy; respiratory function

The goal of this research is to improve our understanding of the treatment and prevention of Pneumocystis carinii pneumonia (PCP) in men, women and children with HIV 1 infection. The specific objectives are to study: 1) the efficacy, toxicity, and pharmacokinetics of high dose, aerosolized pentamidine prophylaxis in adult patients, 2) the pharmacokinetics of parenteral pentamidine in asymptomatic, HIV 1 infected men and women who are at risk for the development of PCP, 3) the pharmacokinetics of prophylactic aerosolized and parenteral pentamidine in asymptomatic, HIV 1 infected children, 4) the pharmacokinetics of parenteral pentamidine in children who are being treated for acute PCP. In the adult study, 150 patients will receive either 600 mg once-monthly or 300 mg once-monthly (double-blind) of aerosolized pentamidine prophylaxis. End point analysis includes occurrence of PCP, toxicity and death. In a subset of 20 of these patients, an intensive study of toxicity and pharmacokinetics will be carried out using serial pulmonary function testing and measurement of pentamidine concentration in bronchoalveolar lavage fluid and plasma. The pharmacokinetics of pentamidine will be studied in an additional 80 individuals in the following categories: Group 1: 15 women who are being treated for PCP with intravenous pentamidine, Group 2: 10 volunteer, asymptomatic HIV+ women who are at risk for PCP, Group 3: 10 volunteer asymptomatic HIV men (control group) who are at risk for PCP, Group 4: 15 children, age < 13 years, who are receiving treatment for PCP with intravenous pentamidine, Group 5: 15 asymptomatic HIV+ children who are receiving once monthly intravenous prophylaxis, Group 6: 15 HIV+ asymptomatic children who are receiving once monthly aerosolized prophylaxis for pentamidine. Serial blood and urine specimens will be obtained according to the enclosed protocols, pentamidine will be assayed using high performance liquid chromatography, and the kinetics will be calculated using standard modelling techniques.

这项研究的目的是提高我们对治疗的理解 预防男性，女人和 艾滋病毒1感染的儿童。 具体目标是研究：1） 高剂量，雾化的功效，毒性和药代动力学 成年患者的五丹胺预防，2） 无症状，艾滋病毒1感染的男性和女人 有PCP开发的风险，3） 无症状的HIV 1 感染儿童，4） 正在接受急性PCP治疗的孩子。 在成人研究中，每月一次或 300毫克气泡五天二胺的预防剂一次（双盲）。 终点分析包括PCP，毒性和死亡的发生。 在 这些患者中有20例的子集，一项对毒性和 药代动力学将使用串行肺功能进行 在支气管肺泡中的戊二胺浓度测试和测量 灌洗液和血浆。 将在80次中研究五丹胺的药代动力学 以下类别中的个人：第1组：15个妇女 用静脉注射五达米胺治疗PCP，第2组：10志愿者， 无症状的艾滋病毒+有pcp风险的妇女，第3：10组志愿者 无症状的艾滋病毒男性（对照组）有PCP风险，第4组：15 儿童，年龄<13岁，正在接受PCP治疗 静脉注射五达米胺，第5组：15个无症状HIV+儿童 每月接受一次静脉预防，第6组：15 HIV+ 无症状的儿童每月收到一次雾化的儿童 预防五丹胺。 连环血和尿液标本将是 将根据封闭方案获得，将分析五达米二 使用高性能液相色谱法，动力学将是 使用标准建模技术计算。