NCT00144261已完成4 期
An Open-label, Non-randomized, Single-arm Study, to Investigate the Mechanism(s) by Which Nevirapine Increases Plasma High Density Lipoproteins Concentration in HIV+ Subjects Treated With VIRAMUNE® Tablets
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 3
- 主要终点
- Percentage change of flow mediated dilatation (FMD)
研究概览
简要总结
- In order to obtain further insight as to how NVP affects HDL metabolism, the in vivo kinetics of the HDL apolipoprotein, Apo A-1, before and 6 weeks after initiation of NVP containing treatment were evaluated. In addition, the activity of the key enzymes related to HDL metabolism were assessed.
[ Designated as safety issue: No ] 2. In order to determine the relevance of the HDL increase in decreasing cardiovascular risk in HIV-positive subjects we evaluated endothelial function (FMD) as a surrogate marker for cardiovascular disease in patients.
[ Designated as safety issue: No ]
研究设计
- 研究类型
- Interventional
- 主要目的
- Prevention
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 will be included when they meet the following criteria:
- •18 years of age or older.
- •Ability and willingness to provide signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation.
- •Patients on stable therapy with Trizivir only (or its equivalent component drugs), for at least 6 months prior to screening.
- •Patients with plasma HIV-1-RNA <=50 copies/mL documented on at least two occasions within 6 months prior to enrollment.
- •Documentation of plasma HIV-1 RNA of <=50 copies/mL for >=6 months while on Trizivir without other antiretroviral agent. Documentation will include dates and results of all viral load testing from the previous six months.
- •Ability and willingness to complete the study.
排除标准
- •Patients will not be included when they meet one or more of the following criteria:
- •Previous exposure to NNRTI drugs.
- •Documented diabetes mellitus.
- •Documented hypertension (systolic >155 mmHg and/or diastolic >95 mmHg).
- •Fasting hypertriglyceridemia (>5.6 mmol/L or 500 mg/dl).
- •Use of lipid-lowering medication during the 90 days prior to study enrollment.
- •Chronic active hepatitis B and/or C infection by history.
- •Anemia (Hb <7.0 mmol/l or 11 g/dl hematocrit <32%).
- •Active opportunistic infection or neoplasm within 3 months prior to screening visit with the exception of cutaneous Kaposi's sarcoma without evidence of progressive disease.
- •Any history of cardiovascular disease (infarction, heart failure, peripheral vascular disease, cerebrovascular disease).
- •Hepatic, renal or thyroid abnormalities, as determined significant by the Principal Investigator.
- •Pregnancy or lactation.
- •Active anticoagulation therapy (coumarin derivates, heparin).
- •History of HIV-2 infection.
- •Female patients with CD4 counts >250 cells/mm
- •Male patients with CD4 counts >400 cells/mm
- •Others which can not be listed here.
结局指标
主要结局
Percentage change of flow mediated dilatation (FMD)
时间窗: after 6 and 24 weeks of treatment
Percentage change of fractional synthetic rate (FSR) of Apo A-1
时间窗: after 6 weeks of treatment
次要结局
- Percentage change in the proteins involved in HDL metabolism(after 6 and 24 weeks of treatment)
- The percentage change in plasma levels of lipoproteins in the fasting lipid panel (TC, LDL, HDL, TG) from Week 0 (baseline) to 6 and 24 weeks of treatment with NVP-based antiretroviral therapy(from week 0 to 6, and 24 weeks of treatment)
- The percentage change in activity (and/or mass) of the constituents of the lipid enzymes panel from Week 0 to 24 weeks of NVP-based antiretroviral therapy(from week 0 to 24 weeks of treatment)
研究者
研究点 (3)
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