Comparison Atazanavir/Ritonavir (ATV/r) vs Nevirapine (NVP) Twice a Day (Bid) on Truvada Backbone
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 154
- 试验地点
- 19
- 主要终点
- Number of Participants With Virologic Response (VR)
研究概览
简要总结
The aim of this clinical trial is to compare the efficacy and safety of ritonavir (RTV)-boosted atazanavir with nevirapine, each on a background of emtricitabine and tenofovir disoproxil fumarate (DF).
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
NVP 200mg bis indie (BID)
after receiving nevirapine (NVP) 200 mg quaue die (QD) for 2 weeks, pt titrated to NVP 200 mg bis in die (BID) combined with emtricitabine 200 mg QD/ tenofovir DF 300 mg QD (fixed dose combination Truvada) for 48 weeks
干预措施: tenofovir DF 300 mg QD (Drug)
NVP 200mg bis indie (BID)
after receiving nevirapine (NVP) 200 mg quaue die (QD) for 2 weeks, pt titrated to NVP 200 mg bis in die (BID) combined with emtricitabine 200 mg QD/ tenofovir DF 300 mg QD (fixed dose combination Truvada) for 48 weeks
干预措施: emtricitabine 200 mg QD (Drug)
NVP 200mg bis indie (BID)
after receiving nevirapine (NVP) 200 mg quaue die (QD) for 2 weeks, pt titrated to NVP 200 mg bis in die (BID) combined with emtricitabine 200 mg QD/ tenofovir DF 300 mg QD (fixed dose combination Truvada) for 48 weeks
干预措施: Nevirapine 200 mg BID (Drug)
Atazanavir 300 mg QD/ritonavir 100 mg QD
patients to receive atazanavir 300 mg QD boosted with ritonavir 100 mg QD combined with emtricitabine 200 mg QD/ tenofovir DF 300 mg QD (fixed dose combination Truvada) for 48 weeks
干预措施: tenofovir DF 300 mg QD (Drug)
Atazanavir 300 mg QD/ritonavir 100 mg QD
patients to receive atazanavir 300 mg QD boosted with ritonavir 100 mg QD combined with emtricitabine 200 mg QD/ tenofovir DF 300 mg QD (fixed dose combination Truvada) for 48 weeks
干预措施: emtricitabine 200 mg QD (Drug)
Atazanavir 300 mg QD/ritonavir 100 mg QD
patients to receive atazanavir 300 mg QD boosted with ritonavir 100 mg QD combined with emtricitabine 200 mg QD/ tenofovir DF 300 mg QD (fixed dose combination Truvada) for 48 weeks
干预措施: Atazanavir 300 mg (Drug)
Atazanavir 300 mg QD/ritonavir 100 mg QD
patients to receive atazanavir 300 mg QD boosted with ritonavir 100 mg QD combined with emtricitabine 200 mg QD/ tenofovir DF 300 mg QD (fixed dose combination Truvada) for 48 weeks
干预措施: Ritonavir 100 mg (Drug)
结局指标
主要结局
Number of Participants With Virologic Response (VR)
时间窗: baseline to week 48
VR is defined as HIV viral load of \<50 copies/ml measured at two consecutive visits PRIOR TO Week 48 and without subsequent rebound or change of ARV therapy prior to Week 48.
次要结局
- Change in Fasting Plasma Triglycerides Level(baseline to week 48)
- Number of Participants With Virologic Response According to the Time to Loss of Virologic Response (TLOVR) Algorithm(baseline to week 48)
- Number of Participants With HIV Viral Load < 400 Copies/ml at Week 6 of Treatment(baseline to week 6)
- Number of Participants With HIV Viral Load < 50 Copies/ml at Week 48(baseline to week 48)
- Number of Participants With Virologic Success (FDA Definition)(baseline to week 48)
- Time to Virologic Response (First Confirmed Viral Load < 50 Copies/ml), All Participants(baseline to week 48)
- Number of Participants With Loss of Virologic Response Following Confirmed Virologic Response(baseline to week 24 and week 48)
- Change in CD4+ Cell Count From Baseline to Week 6.(baseline to week 6)
- Change in CD4+ Cell Count From Baseline to Week 8.(baseline to week 8)
- Change in CD4+ Cell Count From Baseline to Week 36.(baseline to week 36)
- Change in Fasting Plasma Total Cholesterol Level(baseline to week 48)
- Time to Virologic Response (First Confirmed Viral Load < 50 Copies/ml), Only Participants With Confirmed Viral Load < 50 Copies/ml(baseline to week 48)
- Number of Participants With HIV Viral Load < 50 Copies/ml at Week 2 of Treatment(baseline to week 2)
- Number of Participants With HIV Viral Load < 50 Copies/ml at Week 4 of Treatment(baseline to week 4)
- Number of Participants With HIV Viral Load < 50 Copies/ml at Week 6 of Treatment(baseline to week 6)
- Number of Participants With HIV Viral Load < 50 Copies/ml at Week 8 of Treatment(baseline to week 8)
- Number of Participants With HIV Viral Load < 50 Copies/ml at Week 12 of Treatment(baseline to week 12)
- Number of Participants With HIV Viral Load < 50 Copies/ml at Week 24 of Treatment(baseline to week 24)
- Number of Participants With HIV Viral Load < 50 Copies/ml at Week 36 of Treatment(baseline to week 36)
- Number of Participants With HIV Viral Load < 50 Copies/ml at Week 48 of Treatment(baseline to week 48)
- Number of Participants With HIV Viral Load < 400 Copies/ml at Week 2 of Treatment(baseline to week 2)
- Number of Participants With HIV Viral Load < 400 Copies/ml at Week 4 of Treatment(baseline to week 4)
- Number of Participants With HIV Viral Load < 400 Copies/ml at Week 8 of Treatment(baseline to week 8)
- Number of Participants With HIV Viral Load < 400 Copies/ml at Week 12 of Treatment(baseline to week 12)
- Number of Participants With HIV Viral Load < 400 Copies/ml at Week 24 of Treatment(baseline to week 24)
- Number of Participants With HIV Viral Load < 400 Copies/ml at Week 36 of Treatment(baseline to week 36)
- Change in CD4+ Cell Count From Baseline to Week 2.(baseline to week 2)
- Change in CD4+ Cell Count From Baseline to Week 12.(baseline to week 12)
- Number of Participants With HIV Viral Load < 400 Copies/ml at Week 48 of Treatment(baseline to week 48)
- Number of Patients With Virologic Rebound to >400 Copies/ml(baseline to week 48)
- Incidence of Patients With AIDS Progression at Each Visit(baseline to week 52)
- AIDS Progression and Death: Number of Patients With a Treatment-emergent AIDS Defining Illness or an AIDS-defining Illness Leading to Death(baseline to week 48)
- Change in CD4+ Cell Count From Baseline to Week 4.(baseline to week 4)
- Change in CD4+ Cell Count From Baseline to Week 24.(baseline to week 24)
- Proportion of Patients Reporting CNS Side Effects of Any Severity(baseline to week 52)
- Proportion of Patients Reporting Hepatic Events of Any Severity(baseline to week 52)
- Change in CD4+ Cell Count From Baseline to Week 48.(baseline to week 48)
- Change in Fasting High Density Lipoprotein (HDL) Cholesterol Level(baseline to week 48)
- Change in Fasting Low Density Lipoprotein (LDL)Cholesterol Level(baseline to week 48)
- Proportion of Patients Reporting Rash of Any Severity(baseline to week 52)
- Proportion of Patients With DAIDS Grade >= 2 Laboratory Abnormalities(baseline to week 52)
- Change in Fasting Total Cholesterol to High Density Lipoprotein (HDL) Ratio(baseline to week 48)
- Change in Framingham Score(baseline to week 48)
- Change in Revised Framingham Score According to the Data Collection on Adverse Events of Anti-HIV Drugs (DAD) Study Group(baseline to week 48)
- Change in Glomerular Filtration Rate (GFR) From Baseline to Week 48(baseline to week 48)
- Percentage Adherence by Pill Count(baseline to week 48)
- Number of Participants With Genotypic Resistance at the Time of Virologic Failure.(baseline to week 48)