PHASE I/II ANTIVIRAL ACTIVITY OF 9R2, PROPYLADENINE (PMPA) IN HIV INFECTION

9R2 丙腺嘌呤 (PMPA) 在 HIV 感染中的 I/II 期抗病毒活性

• 批准号: 6218234
• 负责人: PATRICIA A BARDITCH-CROVO
• 金额: $ 0.23万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 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/6218234
• 关键词: AIDS therapy; HIV infections; adenine analog; antiviral agents; clinical research; clinical trial phase I; drug screening /evaluation; human subject; human therapy evaluation

PMPA, a nucleotide reverse transcriptase inhibitor, has shown anti-HIV activity in vitro and was well tolerated in several animal species over a range of doses. The drug should be safe and well tolerated in people with HIV infection and show anti-HIV activity as evidenced by change in viral RNA PCR after seven days of daily administration. The objectives of this proposed study are to (a) evaluate the safety and single and multiple doses of PMPA when administered intravenously to HIV-infected subjects (b) to evaluate the pharmacolinetics of single and multiple doses of PMPA and (c) to evaluate the anti-HIV effect of PMPA as demonstrated by effects on CD4 count and HIV RNA.

PMPA是一种核苷酸逆转录酶抑制剂，已在体外显示出抗HIV活性，并且在多种动物种属中在一定剂量范围内耐受良好。 该药物在HIV感染者中应安全且耐受性良好，并显示抗HIV活性，如每日给药7天后病毒RNA PCR的变化所证明。本拟定研究的目的是（a）评价HIV感染受试者静脉注射PMPA的安全性以及单次和多次给药（B），以评价PMPA单次和多次给药的药理学作用，（c）评价PMPA的抗HIV作用，如对CD 4计数和HIV RNA的影响所示。