Efficacy of Simplification to Atazanavir/Ritonavir + Lamivudine as Maintenance Therapy in Patients With Viral Suppression. Randomized, Open-label 96 Weeks Non-inferiority Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 286
- 试验地点
- 36
- 主要终点
- To assess the non-inferiority of maintenance therapy with ATV/RTV + 3TC vs ATV/RTV + 2 optimized NRTIs
研究概览
简要总结
A switch to a regimen consisting of ATV/RTV 300/100 mg QD + 3TC 300 mg QD in HIV-1 infected subjects in their first antiretroviral regimen and who are virologically suppressed on a regimen which consists of 2 NRTIs + any 3rd agent, is non-inferior to continue or switch to ATV/RTV 300/100 mg QD + 2 optimized NRTIs for maintenance of virological suppression.
详细描述
Clinical Trial, phase IV, randomized, open label, multicenter with approved drugs in their use conditions.
A switch to a regimen consisting of ATV/RTV 300/100 mg QD + 3TC 300 mg QD in HIV-1 infected subjects in their first antiretroviral regimen and who are virologically suppressed on a regimen which consists of 2 NRTIs + any 3rd agent, is non-inferior to continue or switch to ATV/RTV 300/100 mg QD + 2 optimized NRTIs for maintenance of virological suppression.
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
- •Signature of informed consent
- •At least 18 years old
- •Patients on their 1st ARV treatment consisting on 2 NRTIs + 1 third agent for at least 1 year
- •Undetectable viral load for at least 6 months prior to inclusion in the study (VL<50 c/mL in 2 determinations 6 months apart; blips are not allowed).
- •Requirement of ARV treatment change due to toxicity, intolerance or simplification.
- •Clinically stable.
排除标准
- •Pregnant women or women who plan to get pregnant during the study.
- •Breast feeding
- •History of change of any ARV treatment component for any reason 4 months prior to the inclusion in the trial
- •History of ARV treatment change due to virological failure
- •History of confirmed virological failure defined as one single VL >400 c/mL or at least 2 VL between 50 and 400 c/mL one year after an indetectable VL was achieved.
- •Absence of HIV genotype prior to ARV treatment initiation.
- •Resistance mutation to any of the study drugs (ATV, RTV, 3TC)
- •HBV infection.
- •History of toxicity or intolerance to ATV, RTV or 3TC.
- •Gilbert's syndrome.
- •Use of contraindicated drugs.
- •Lab abnormalities grade 4.
研究组 & 干预措施
ATV/r+3TC
Subjects will receive ATV/RTV 300/100 mg QD + 2 optimized NRTIs for the first 4 weeks and then they will receive ATV/RTV 300/100 mg QD (once daily) and 3TC 300 mg QD for another 92 weeks. Treatment should be taken orally with a light meal at the same time each day.
干预措施: Ritonavir boosted Atazanavir + Lamivudine (Drug)
ATV/r+2 NRTIs
Subjects will receive ATV/RTV 300/100 mg QD + 2 optimized NRTIs for 96 weeks. Treatment should be taken orally with a light meal at the same time each day.
干预措施: Ritonavir boosted Atazanavir + 2 NRTIs (Drug)
结局指标
主要结局
To assess the non-inferiority of maintenance therapy with ATV/RTV + 3TC vs ATV/RTV + 2 optimized NRTIs
时间窗: Week 48
Non-inferiority will be considered when the difference in proportion of efficacy between experimental arm (ATV/RTV + 3TC) vs. control arm (ATV/RTV + 2 optimized NRTIs) arm is less or equal to -0.12% after 48 weeks of treatment
次要结局
- To assess the non-inferiority of maintenance therapy with ATV/RTV + 3TC vs ATV/RTV + 2 optimized NRTIs(week 96)
- To assess safety after 24 weeks fo treatment(Week 24)
- To assess safety after 48 weeks fo treatment(Week 48)
- To assess safety after 96 weeks fo treatment(Week 96)
- To assess the incidence of resistance, and characterization of this resistance following a virological rebound(Week 96)
- To assess neurocognitive function evolution(Week 96)