Phase II Randomized Trial Comparing Efficacy and Safety of the Maintenance of a HAART Association Protease Inhibitor Containing Versus a Once Daily Antiretroviral Triple Association, in HIV Adult Patients With Undetectable Viral Load.ANRS 099 ALIZE
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 350
- 主要终点
- Virological success from W0 to W48
研究概览
简要总结
The combination of two nucleoside analogues and one protease inhibitor is a highly active antiretroviral therapy (HAART) in HIV infected adults. In those with an undetectable viral load, a once daily combination of FTC, ddI, efavirenz would be easier to take, with less side effects and the same efficacy. The aim of the study was to evaluate if the once daily combination presents the same efficacy than the HAART therapy with less side effects and a better adherence.
详细描述
The combination of two nucleoside analogues and one protease inhibitor is a highly active antiretroviral therapy (HAART) in HIV infected adults, but side effects an the great number of pills induces less adherence to the therapy. Once daily combination with a lower number of pills could be more easy to take, with a greater adherence, less side effects, and the same efficacy. 355 patients are recruited in the study, randomized in two treatment groups: maintenance of the HAART therapy versus changing for a once daily combination of FTC, ddI, efavirenz, during 48 weeks. The primary end-point is the viral success maintained until 48 weeks. Secondary end-point is the safety and adherence.
The trial is prolonged for a total of 48 weeks.
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 infected adults
- •Antiretroviral treatment since 6 months, with two nucleoside analogues and one or two protease inhibitors
- •CD4 cell count over 100/mm3
- •HIV RNA below 400 copies/ml since 6 months
- •Signed written informed consent
排除标准
- •Previous treatment with non nucleoside analogue, ddI alone
- •Pregnancy
- •Alcool abuse
- •Acute infection, past neurological or pancreatic disease, biological abnormalities
- •Chemotherapy or immunotherapy
结局指标
主要结局
Virological success from W0 to W48
次要结局
- Quality of life
- Viral mutations
- Therapeutic strategy failure
- Progression of HIV infection
- CD4 cell count
- Safety
- Treatment adherence