临床试验/NCT02191319

NCT02191319已完成不适用

Observational Study With Antiretroviral Treated Patients Switching Therapy Because of Therapeutic Reasons From Protease Inhibitor- or NNRTI-containing Regimens to Nevirapine Plus Two Nucleoside Reverse Transcriptase Inhibitor (NRTI) Regimens

Boehringer Ingelheim0 个研究点目标入组 55 人开始时间: 2002年1月最近更新: 2014年7月16日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方: Boehringer Ingelheim
入组人数: 55
主要终点: Change in CD4 cell count

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

Collecting data on maintaining anti-retroviral activity (quantitative HIV RNA determination) and immunological activity (CD4 cells) after switching from protease inhibitor or NNRTI to Nevirapine (Viramune®) and collecting of routinely observed laboratory data on lipids, and liver enzymes.

研究设计

研究类型: Observational
观察模型: Cohort
时间视角: Prospective

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

•Patients suffer from HIV type 1 infection
•Patient is treated with antiretroviral protease-inhibitors or non-nucleoside reverse transcriptase inhibitors
•Patient has shown a depression of viral load before limit of detection (< 50 HIV-RNA copies/ml) for more than 6 months prior to visit 1
•Patient is male or female with age greater than or equal to 18 years
•Women have to be willing to use an effective barrier method of contraception for the duration of the observational study participation

排除标准

•Patient has clinically relevant laboratory findings (e.g., aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > five times upper limit of normal (ULN))
•Patients is hypersensitive to Viramune® or to any of its excipients
•Patient is not able to abstain from treatment with ketoconazole, oral contraceptives, or other drug affecting CYP3A-metabolism
•Patients is breast-feeding
•Patient is pregnant
•Patient is a woman and does not use effective contraception

研究组 & 干预措施

Viramune®

Patients switching from protease inhibitor (PI) or nonnucleoside reverse transcriptase inhibitor (NNRTI) containing antiretroviral regimen to Viramune®

干预措施: Viramune® (Drug)

结局指标

主要结局

Change in CD4 cell count

时间窗: Baseline, up to 52 weeks

Change in viral load (HIV-RNA)

时间窗: Baseline, up to 52 weeks

Change in lipid parameters

时间窗: Baseline, up to 52 weeks

mg/dl

Change in glucose

时间窗: Baseline, up to 52 weeks

mg/dl

次要结局

Change in liver enzyme parameter(Baseline, up to 52 weeks)
Assessment of subjective well-being(up to 52 weeks)
Assessment of tolerability by physician and patients(after 52 weeks)
Number of patients with adverse events(up to 52 weeks)

研究者

发起方

Boehringer Ingelheim

申办方类型

Industry

责任方

Sponsor

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