A Phase IV, Prospective, Multicenter , Randomized Open Label, 48 Weeks Study to Evaluate the Antiretroviral Efficacy and Safety of Atazanavir or Darunavir,Each in Combination With a Fixed Dose of Tenofovir Emtricitabine in HIV-1-infected Treatment-naïve Subjects With CD4counts Below 200 µL.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 29
- 主要终点
- Viral load of HIV-1 < 50 cp/ml
研究概览
简要总结
A phase IV, prospective, multicenter , randomized open label, 48 weeks study to evaluate the antiretroviral efficacy and safety of atazanavir/ritonavir or darunavir/ritonavir, each in combination with a fixed dose of tenofovir disoproxil fumarate- emtricitabine in HIV-1-infected treatment-naïve subjects with CD4 counts below 200 µL.
详细描述
Principal objective
To evaluate the virological efficacy and safety at week 48 of 2 regimens atazanavir/ritonavir (ATZ/r) 300/100 mg or darunavir/ritonavir (DRV/r) 800/100 mg, each in combination with a fixed-dose of tenofovir/emtracitabine in HIV-1 treatment-naïve subjects with CD4 counts below 200 µL.
Secondary objectives
- Proportion of subjets with virologic efficacy at week 24
- Proportion of subjects with confirmed virologic failure at week 24 or later
- Proportion of patients with virologic mutations
- Evaluate the virologic effect in seminal fluid
- To evaluate immunological response over time up to week 48
- To assess plasma and seminal pharmacokinetics of the drugs in the treatment regimen at week 4, 24, and 48
- Correlate the pharmacokinetic properties of the drugs with virologic outcome in plasma and semen at week 4 and 48
- Correlate the free fraction (not bound to protein) of atazanavir and darunavir in plasma and semen to virologic outcome
- Evaluate the relationship of bilirubinemia with atazanavir
- Change from baseline in fasting lipids, fasting glucose and insulin over time in the 2 arms
- Compare adherence patient satisfaction and sexual behaviour between the regimens
Methodology
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
ATAZANAVIR
The patient included in this Group 1 will receive their first antiretroviral regimen included : ATV + TDF/FTC (or Abacavir/Lamivudine, [ABC/3TC], if contre indicated of TDF/FTC) The dose : atazanavir/ritonavir 300/100mg/day and TDF/FTC 245 /200 mg day, 3 pills once a day, during 48 weeks during a meal
干预措施: ATAZANAVIR (Drug)
DARUNAVIR
The patients included in this Group 2 will receive their first antiretroviral regimen included Group 2 : DRV+ TDF/FTC (or ABC/3TC if contre-indicated of TDF/FTC) The dose : darunavir/ritonavir 800/100mg/day and TDF/FTC 245 /200 mg day, 4 pills once a day, during 48 weeks during a meal
干预措施: DARUNAVIR (Drug)
结局指标
主要结局
Viral load of HIV-1 < 50 cp/ml
时间窗: 48 weeks
To evaluate the virological efficacy and safety at week 48 of 2 regimens atazanavir/ritonavir (ATZ/r) 300/100 mg or darunavir/ritonavir (DRV/r) 800/100 mg, each in combination with a fixed-dose of tenofovir/emtracitabine in HIV-1 treatment-naïve subjects with CD4 counts below 200 µL
次要结局
- Immunologic response(W-4,W2,W4,W12,W24 and W48)
- • Proportion of subjets with virologic efficacy(24 weeks)
- Viral lod of HIV-1 on seminal fluid(W00,W4 et W48)
- Differenciation and activation of lymphocytes(W0,W2,W4,W12,W24 and W48)
- Pharmacokinetics evaluation of the drugs in plasma(W4,W24 and W48)
- Pharmacokinetic evaluation of the drugs in semen(W4 and W48)
- • Proportion of subjects with confirmed virologic failure(24 weeks)
- • Evaluate the relationship of bilirubinemia with atazanavir(W4 and W48)
- Fasting glucose, lipids and insulin(W48)
- Clinic and biologic tolerance(W48)
- Sexual behaviour(W0,W24 et W48)
- Adherence patient satisfaction(W2,W24 et W48)