NCT02159599已完成4 期
An Open Label Randomized Clinical Trial, to Evaluate the Treatment With Darunavir/Ritonavir + Lamivudine Once Daily Versus Continuing With Darunavir/Ritonavir Once Daily + Tenofovir/Emtricitabine or Abacavir/Lamivudine in HIV Infected Subject With Suppressed Plasma Viremia
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 249
- 试验地点
- 21
- 主要终点
- Proportion of patients with undetectable viral load
研究概览
简要总结
This is an open label randomized clinial trial to evaluate the treatment with darunavir/ritonavir (800mg/100mg) plus lamivudine (300 mg) once daily versus continuing with darunavir/ritonavir (800mg/100mg) once daily plus tenofovir/emtricitabine (300mg/200mg) or abacavir/lamivudine (600mg/300mg) in HIV infected subject with suppressed plasma viremia.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Acceptance to participate in the study, signing the informed consent document before conducting any study procedures.
- •Patient with HIV infection older than 18 years.
- •Treatment with darunavir/ritonavir once a day and tenofovir/emtricitabine or abacavir/lamivudine during at least 4 weeks at the moment of the screening
- •Plasma HIV RNA levels below 50 copies / ml for at least 6 months (two separate measurements at least 6 months with viremia <50 copies / ml between both).
- •HbsAg negative
排除标准
- •Pregnant or breastfeeding woman
- •Evidence of Lamivudine resistance (any previous genotype with mutation M184V/I or K65R) and/or to darunavir (population genotype show any of the following mutations: V11I, V32I, L33F, I47V, I50V, I54L/M, G73S, T74P, L76V, I84V, L89V).
- •History of virology failure (two consecutive viral loads above 200 copies/ml) while the patient was receiving a regimen with lamivudine or emtricitabine, with the following exceptions:
- •Do not consider an exclusion criterion if the genotype performed at the time of failure does not demonstrate resistance to lamivudine and darunavir (see criteria 2).
- •Do not consider an exclusion criteria in the absence of genotype if after the episode turns to maintain a viral load <50 copies / ml with a treatment composed of lamivudine or emtricitabine + a nucleoside + a non-nucleoside.
- •History of abandonment of treatment including lamivudine or emtricitabine, with the following exception:
- •Viral load prior to abandonment was <50 copies / ml and subsequent reintroduction of the same treatment or another treatment consisting of lamivudine or emtricitabine + a nucleoside + a non-nucleoside returns to maintain viral load below 50 copies / ml .
- •Previous treatment with bitherapy or monotherapy with lamivudine or emtricitabine
- •Previous treatment with bitherapy or monotherapy with a regimen with a protease inhibitor that is terminated by viral rebound, when the absence of a genotypic resistance test available after viral rebound allow discard the resistance mutations either drug used.
- •The use of concomitant medication not permitted
- •Presence of active acute infection, including opportunist infection that a judge of investigator that can difficult the participation in the trial
- •Any laboratory results of the following: hemoglobin<8,0 g/dl; neutrophils <750 cells/µl; platelets <50.000 cell/µl; creatinine ≥ 1,5 ULN (upper limit of normal)
- •Any clinical or analytic event that, in the investigator judgment, condition the patient safety
研究组 & 干预措施
Darunavir/Ritonavir + 2 nucleos(t)idos
Active Comparator
Darunavir/Ritonavir ( (800mg/100mg) + Tenofovir/emtricitabine (300mg/200mg) or Abacavir/lamivudine (600 mg/300mg)
干预措施: Darunavir/Ritonavir (Drug)
Darunavir/Ritonavir + 2 nucleos(t)idos
Active Comparator
Darunavir/Ritonavir ( (800mg/100mg) + Tenofovir/emtricitabine (300mg/200mg) or Abacavir/lamivudine (600 mg/300mg)
干预措施: Emtricitabine/tenofovir or abacavir/lamivudine (Drug)
Darunavir/ritonavir + Lamivudine
Experimental
Darunavir/Ritonavir (800mg7100mg) + lamivudine (300mg)
干预措施: Darunavir/Ritonavir (Drug)
Darunavir/ritonavir + Lamivudine
Experimental
Darunavir/Ritonavir (800mg7100mg) + lamivudine (300mg)
干预措施: Lamivudine (Drug)
结局指标
主要结局
Proportion of patients with undetectable viral load
时间窗: week 48
Undetectable viral load \<50 copies/ml according to the FDA snapshot algorithm
次要结局
- Proportion of patients with undetectable viral load(Week 24)
- Proportion of patients with viral load < 200 copies/ml(week 48)
- Proportion of patients who present viral load ≥ 50 copies /ml one time(From basal visit until week 48 visit)
- Proportion of patients who present viral load ≥ 50 copies /ml more tan two times(From basal visit until week 48 visit)
- Proportion of patients who maintained viral load < 50 copies/ml in all determinations(week 48)
- Median of change cells CD4/µl count from basal to week 48(week 48)
- Median of change in triglycerides , LDL-cholesterol, HDL-cholesterol and total cholesterol from basal to week 48(week 48)
- Change in renal function(week 48)
- Change in proportion of patients with renal tubular dysfunction(week 48)
研究者
研究点 (21)
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