PROAB3004: SAFETY, EFFICACY & PK 0F 141W94 + CURRENT RX IN HIV+ CHILDREN

PROAB3004：安全性、有效性

• 批准号: 6264599
• 负责人: William Borkowsky
• 金额: $ 2.1万
• 依托单位: NEW YORK UNIVERSITY SCHOOL OF MEDICINE
• 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/6264599
• 关键词: HIV infections; adolescence (12-20); antiAIDS agent; child (0-11); clinical research; combination chemotherapy; drug adverse effect; human subject; human therapy evaluation; pediatric AIDS; pediatric pharmacology; pharmacokinetics; protease inhibitor; reverse transcriptase inhibitors; sulfonamides; virus RNA

The primary objectives of this open label single arm noncomparative trial are to evaluate the safety and tolerability of 141W 94 in HIV-infected pediatric subjects (ages 4-18) for a minimum 48 week period and to determine the antiviral effect of 141W94 in combination with current antiretroviral therapy, based on plasma HIV RNA levels. The study is also designed to assess the pharmacokinetics of 141W94 in combination with two nucleoside reverse transcriptase inhibitors in HIV-1 infected children.

这项开放标签单组非比较试验的主要目的是评价141 W 94在HIV感染的儿科受试者（4-18岁）中至少48周的安全性和耐受性，并根据血浆HIV RNA水平确定141 W 94联合当前抗逆转录病毒治疗的抗病毒作用。 本研究还旨在评估141 W 94联合两种核苷逆转录酶抑制剂在HIV-1感染儿童中的药代动力学。