临床试验/NCT00205283

NCT00205283已完成不适用

Nelfinavir and M8 Drug-level Monitoring in HIV-1 Infection

University of Wisconsin, Madison2 个研究点分布在 1 个国家目标入组 20 人开始时间: 2003年8月最近更新: 2019年3月22日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: University of Wisconsin, Madison
入组人数: 20
试验地点: 2
主要终点: Virologic response

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to assess the impact of prospective drug level monitoring and dose-adjustment of nelfinavir (NFV) on the clinical and virologic outcomes in a group of HIV-infected patients who have achieved virologic success while receiving a nelfinavir containing highly active antiretroviral therapy (HAART) regimen.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Parallel
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Antiretroviral naive or currently taking a nelfinavir containing HAART regimen where nelfinavir is the first protease inhibitor
•Patients willing to comply with the protocol
•Age greater than or equal to 18 years
•Virologically successful if already on an established regimen

排除标准

•Prior use of a protease inhibitor exclusive of nelfinavir
•Required use or concomitant use of drugs that may interact with or are contraindicated with nelfinavir
•Use of immunomodulators or vaccines for HIV disease
•Intercurrent illness at the time of enrollment that, in the clinician's judgement, could influence the HIV RNA concentration
•Baseline ALT levels greater than five times the upper limit of normal

结局指标

主要结局

Virologic response

Nelfinavir pharmacokinetics

次要结局

Impact of nelfinavir and M8 pharmacokinetics on virologic response

研究者

发起方

University of Wisconsin, Madison

申办方类型

Other

责任方

Sponsor

研究点 (2)

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