NCT00114933已完成4 期
Phase III-IV, Comparative, Randomized, Open-Label, Study to Evaluate Safety and Efficacy of Suspending Nucleosides From a Triple-Drug Therapy Based on Lopinavir/Ritonavir Versus Continuing Triple-Drug Therapy in HIV-Infected Subjects With Undetectable Plasma HIV Viremia for Six Months
Arribas, Jose R., M.D.56 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2005年1月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 56
- 主要终点
- % patients with therapeutic failure in both arms at 48 weeks (OT and ITT)
研究概览
简要总结
Lopinavir/ritonavir monotherapy may maintain virologic suppression in patients who have been undetectable for six months while on triple drug antiretroviral therapy. Lopinavir/ritonavir pharmacokinetics might prevent resistance development in patients who experience virological rebound after single-drug simplification.
详细描述
Primary Study Objective: Efficacy and durability of switching to lopinavir/ritonavir single-drug HAART compared to maintaining therapy based on lopinavir/ritonavir and two nucleosides
Secondary Study Objective(s):
- Safety (related drug AEs/SAEs and laboratory anomalies G3/4) through 48 w.
- Resistance profile on patients with sustained virological failure
- QOL comparing stopping nucleosides versus continuing therapy
- Pharmaco-economic analysis comparing treatment cost between the 2 study arms.
- Predicting factors of failure in the stopping nucleosides arm
Subject Population: 200 patients
Study Design:
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
- •HIV patients > 18 years old who provide signed and dated Informed consent.
- •HIV patients who have been receiving lopinavir/ritonavir and two nucleosides during at least 4 weeks.
- •Plasma HIV RNA < 50 cop/ml for six months
排除标准
- •HIV patients who have stopped a protease inhibitor due to virological failure.
- •HIV patients with hepatic or renal insufficiency.
- •HIV patients with positive serum HBVAg
- •HIV patients who require treatment with a lopinavir/r contraindicated medication.
- •HIV pregnant or breastfeeding women.
- •Active drug abuse (including alcohol or recreational drugs). Exception, cannabis, provided the investigator is confident in patient adherence. Patients under Methadone program will be accepted too if deemed appropriate by the investigator.
结局指标
主要结局
% patients with therapeutic failure in both arms at 48 weeks (OT and ITT)
次要结局
- % patients with virological failure: HIV-RNA > 500 cop/ml under the randomly assigned therapy (OT and ITT)
- % patients with HIV RNA < 500 cop/ml and < 50 cop/ml at w24, w48 (OT and ITT)
- Time to virological failure per Kaplan Meyer analysis
- CD4 cell count change from baseline
- Percentage of viruses with resistance in the protease gene at w24 and w48
- Description of AEs with probable, possible or unknown relationship to study drug
研究者
研究点 (56)
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