EUCTR2014-000515-14-ES进行中（未招募）1 期
Comparative, randomized, open study to evaluate maintenance with Darunavir/ritonavir once daily plus Lamivudine once daily versus continuing Darunavir/ritonavir once-daily plus Tenofovir/Emtricitabine (or Abacavir/Lamivudine) in HIV-infected subjects with undetectable plasma HIV viremia for at least six months.DUAL Study. - DUA
Fundación SEIMC-GESIDA0 个研究点开始时间: 2014年4月4日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Consent to participate in the study, signing and dating the informed consent.
- •2. HIV patients > 18 years old.
- •3.Receiving DRV/r qd + TDF/FTC (or ABC/3TC) for at least 4 weeks.
- •4.Plasma HIV RNA < 50 cop/ml for at least 6 months (2 tests separated at least 6 months with viremia < 50 cop/ml between both determinations).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 256
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 256
排除标准
- •1.HIV pregnant or breastfeeding women.
- •2.Evidence of resistance to 3TC (any previous genotype with M184V/I mutation) and/or Darunavir (poblational genotype with demonstration of any of these mutations: V11I, V32I, L33F, I47V, I50V, I54L/M, G73S, T74P, L76V, I84V, L89V).
- •3.History of virologic failure (two consecutive viral loads of 200 cop/mL) while the patient was receiving 3TC or FTC, with the following exceptions:
- •- Exclusion criteria will not be considered if the genotype performed in the moment of the virologic failure does not demonstrate resistance to 3TC and Darunavir (see exclusion criteria 1).
- •- Exclusion criteria will not be considered in absence of genotype if after the episode a viral load <50 cop/mL is maintained with a treatment composed of 3TC or FTC + 1 nucleoside + 1 non-nucleoside.
- •4.History of withdrawal for treatments including 3TC or FTC, with the following exception:
- •- Viral load prior to withdrawal was <50 cop/mL, followed by reintroduction of the same treatment or other treatment including 3TC or FTC + 1 nucleoside + 1 non-nucleoside showing maintenance of viral load <50 cop/mL.
- •5. Previous dual therapy or monotherapy with 3TC or FTC.
- •6. Previous dual therapy or monotherapy with a protease inhibitor finalized due to virologic breakthrough, when a genotype resistance test is not available after the virologic breakthrough which allows to discard resistance mutations to any of the drugs.
- •7. Use of not allowed concomitant medications.
- •8.Active diseases including opportunistic infections that can difficult the participation in the trial.
- •9.Any of the following: Hemoglobin <8.0 g/dL, neutrophils <750 cel/microL, platelets <50.000 cel/mm3, creatinine > or = 1.5 times upper limit.
- •10.Any analytical or clinical event that could jeopardize the patient's safety.
研究者
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