EUCTR2005-001430-32-ES进行中（未招募）不适用
Estudio fase III, aleatorizado, abierto de Lopinavir/ritonavir comprimidos versus cápsulas de gel blando y su administración una vez al día versus dos veces al día, cuando se coadministran con ITIAN, en sujetos infectados por el VIH-1 sin tratamiento antirretroviral previo. A Phase 3, Randomized, Open-label, Study of Lopinavir/ritonavir Tablets Versus Soft Gel Capsules and Once Daily Versus Twice Daily Administration, when Coadministered with NRTIs in Antiretroviral Naïve HIV-1 Infected Subjects
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 600
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
- •Main Criteria for Inclusion: Adult male or female subjects of atleast 18 years of age, who have provided written informed consent. Plasma HIV-1 RNA > or = 1000 copies/mL at screening, and in the Investigator's opinion requires antiretroviral therapy.Subject is naive to antiretroviral treatment( < 7 days of any antiretroviral therapy and > 30 days prior to study drug administration). Subject has not been treated for an active AIDS-defining opportunistic infection within 45 days of initiating study drug.Subjects who are on stable maintenance therapy for opportunistic infection may be enrolled after consultation with Abbott.Subjects who do not require and agree not to take any drugs that are contraindicated or have a significant pharmacokinetic interaction with study drugs during the course of the study.Subjects who agree not to take any medication including over-the-counter, vitamins, minerals, herbal products etc without the permission of the principal investigator.Non-breast-feeding subjects.Female subjects of non-chlid-bearing potential(post-menopausal for atleast 1 year or surgically sterile), or females of child-bearing potential practising one of the contraceptive methods stated in the protocol. Females who have a negative pregnancy test performed at screening and Day 1. Subjects whose vital signs do not show indication of acute illness.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Subject has a history of an allergic reaction or significant sensitivity to
- •lopinavir/ritonavir, tenofovir disoproxil fumarate, emtricitabine, lamivudine or
- •2. Subject has an ongoing history of substance abuse (recreational drugs, alcohol) or
- •psychiatric illness that could preclude adherence with the protocol.
- •3. Subject has significant history of cardiac, renal, neurologic, psychiatric, oncologic,
- •metabolic or hepatic disease that would adversely affect his/her participating in
- •this study.
- •4. Subject has received any investigational drug or vaccine within 30 days prior to
- •study drug administration.
- •5. For any reason, subject is considered by the investigator to be an unsuitable
- •candidate for the study.
- •6. Screening laboratory analyses show any of the following abnormal laboratory
- •? Presence of hepatitis B surface antigen (HBsAg)
- •? Hemoglobin = 8.0 g/dL
- •? Absolute neutrophil count = 750 cells/µL
- •? Platelet count = 50,000 per mL
- •? ALT (SGOT) or AST (SGPT) = 3.0 x Upper Limit of Normal (ULN)
- •? Calculated creatinine clearance < 50 mL/min
研究者
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