Open-label Randomized Multicenter Trial to Evaluate the Impact on the Lipid Profile of the Substitution of the NRTIs of a HAART Regimen by a Once Daily Fixed Dose Combination Tablet of Emtricitabine and Tenofovir DF Versus Maintained Treatment in HIV Infected Controlled Patients.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Change From Baseline to Week 12 in Fasting Triglycerides
研究概览
简要总结
This study looked at lipid changes in human immunodeficiency virus type 1 (HIV-1) infected patients when the nucleoside reverse transcriptase inhibitors (NRTIs) in their existing highly active antiretroviral therapy (HAART) regimen were switched to Truvada® (a fixed dose combination tablet of emtricitabine/tenofovir disoproxil fumarate 200 mg/300 mg [FTC/TDF]). Subjects continued their nonnucleoside reverse transcriptase inhibitor (NNRTI) or protease inhibitor (PI) at the same dose.
详细描述
This was a Phase IV, multicenter (in France), open label study. The study was conducted in two phases: a comparative randomized phase, which served the primary objective of the study, and a follow-up phase.
Study Phase 1, Day -14 to Week 12: patients were randomized on a 1:1 basis to one of two groups:
- A. Truvada (substitution of their current NRTIs by Truvada [FTC/TDF] with continuation of their current NNRTI or PI at the same dose)
- B. Maintain Baseline Regimen (continuation of previous HAART regimen, i.e., maintained baseline regimen).
This phase of the study served the primary objective of the study.
Study Phase 2, roll-over follow-up, Week 12 to Week 48: Patients in the Truvada group continued with Truvada + an NNRTI or PI. Patients in the control group could switch their NRTIs to Truvada in this phase of the study (Delayed Truvada group).
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Patients displaying abnormal fasted triglycerides (> 2 g/L [2.26 mmol/L] and less than or equal to 10 g/L [11.29 mmol/L]) and/or fasted low density lipoprotein cholesterol (LDL-CHO; > 1.6 g/L [4.15 mmol/L])
- •Patients on stable HAART with 2 NRTIs + 1 NNRTI or 1 PI for at least 3 months prior to screening, and with plasma viral load < 400 copies/mL for at least 6 months prior to screening
排除标准
- 未提供
研究组 & 干预措施
Truvada
Truvada once daily with continuation of the current NNRTI or PI at randomization
干预措施: Truvada (Drug)
Maintain Baseline Regimen
Maintain baseline regimen
干预措施: Current HAART regimen (Drug)
Delayed Truvada
Truvada once daily with NNRTI or PI (participants from the comparator group who switched to Truvada during Study Phase 2)
干预措施: Truvada (Drug)
All Truvada
Truvada once daily with NNRTI or PI (all participants who received Truvada during the study, i.e., participants in the Truvada and Delayed Truvada groups)
干预措施: Truvada (Drug)
结局指标
主要结局
Change From Baseline to Week 12 in Fasting Triglycerides
时间窗: Baseline to Week 12
Centralized laboratory assessment. Change = Week 12 value minus baseline value.
Change From Baseline to Week 12 in Fasting Low-density Lipoprotein Cholesterol (LDL-CHO)
时间窗: Baseline to Week 12
Centralized laboratory assessment. Change = Week 12 value minus baseline value.
次要结局
- Change From Baseline to Week 12 in Fasting High-density Lipoprotein Cholesterol (HDL-CHO)(Baseline to Week 12)
- Change From Baseline to Week 12 in Fasting Total Cholesterol (T-CHO)(Baseline to Week 12)
- Change From Baseline to Week 12 in Fasting T-CHO/HDL-CHO(Baseline to Week 12)
- Change From Baseline to Week 12 in Fasting HDL-CHO/LDL-CHO(Baseline to Week 12)
- Change From Baseline to Week 12 in Fasting Ultra-sensitive C-reactive Protein (Us-CRP)(Baseline to Week 12)
- Percentage of Participants With Fasting Plasma Triglycerides > 10 g/L (> 11.29 mmol/L) at Week 12(12 weeks)
- Change From Baseline to Week 12 in Cluster Determinant 4 (CD4) Cell Count(Baseline to Week 12)
- Change From Baseline to Week 48 in CD4 Cell Count(Baseline to Week 48)
- Percentage of Participants With Virologic Control (Plasma HIV-1 Ribonucleic Acid [RNA] < 400 Copies/mL) at Week 12(12 weeks)
- Percentage of Participants With Plasma HIV-1 RNA Greater Than or Equal to 400 Copies/mL at Week 12(12 weeks)
- Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48(48 weeks)