ACTG#316--PHASE III NEVIRAPINE FOR PREVENTION OF MATERNAL-FETAL TRANS. OF HIV

ACTG

• 批准号: 6114994
• 负责人: ELIZABETH G MCFARLAND
• 金额: $ 1.99万
• 依托单位: UNIVERSITY OF COLORADO DENVER
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6114994
• 关键词: HIV infections; antiviral agents; birth; chemoprevention; clinical research; communicable disease transmission; drug screening /evaluation; drug tolerance; female; human immunodeficiency virus; human pregnant subject; human subject; human therapy evaluation; nevirapine; newborn human (0-6 weeks); pediatric pharmacology; pharmacokinetics; placebos; protease inhibitor; vertical transmission; virus RNA

The primary objective is to evaluate the effects of NVP versus placebo (administered to HIV-infected women in labor and to the infant within the first 48-72 hours of life) on the incidence of HIV transmission. The secondary objectives are: 1) to evaluate the safety and tolerance of oral NVP in pregnant HIV-infected women and in HIV-exposed infants; 2) to determine NVP pharmacokinetic parametes in a large population of neonates; 3) to evaluate the relationship between NVP pharmacokinetic parameters and transmission; 4) to investigate the impact of maternal medications, such as protease inhibitors, on neonatal NVP pharmacokinetic parameters; 5) to evaluate the relationship between maternal viral load at delivery and HIV transmission in both the treatment and control groups; and 6) to determine the effect of nevirapine treatment on HIV RNA levels in infants who are determined to be HIV-infected.

主要目的是评价NVP与安慰剂（用于分娩中的HIV感染妇女和出生后48-72小时内的婴儿）对HIV传播发生率的影响。 次要目的是：1）评价口服NVP在妊娠HIV感染妇女和暴露于HIV的婴儿中的安全性和耐受性; 2）确定NVP在大规模新生儿人群中的药代动力学参数; 3）评价NVP药代动力学参数与传播之间的关系; 4）研究母体药物（如蛋白酶抑制剂）对新生儿NVP药代动力学参数的影响; 5）评价治疗组和对照组中分娩时母体病毒载量与HIV传播之间的关系; 6）确定奈韦拉平治疗对确定为HIV感染的婴儿中HIV RNA水平的影响。