A Prospective, Randomized, Multicenter Trial of Intermittent Therapy in HIV-Infected Patients With Successful Viral Suppression Under HAART (ANRS 106 Window Trial)
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 400
- 试验地点
- 4
- 主要终点
- Immunological failure, defined by a CD4 cell count below 300/µl confirmed by a retest 14 days later during the study
研究概览
简要总结
Although lifelong continuous therapy with HAART remains the standard of care of HIV infection, allowing to achieve undetectable plasma viral RNA, restore CD4 cell count and provide substantial decline in HIV-related morbidity and mortality, long-term toxicity associated with antiretroviral therapy is a real concern. The purpose of this study is to compare an intermittent therapy strategy to a continuous treatment in patients with chronic and well controlled HIV-1 infection.
详细描述
Although lifelong continuous therapy with HAART remains the standard of care of HIV infection, allowing to achieve undetectable plasma viral RNA, restore CD4 cell count and provide substantial decline in HIV-related morbidity and mortality, long-term toxicity associated with antiretroviral therapy is a real concern.
The purpose of this study is to compare an intermittent therapy (IT) strategy (8 weeks off / 8 weeks on) to a continuous treatment (CT) in patients with chronic and well controlled HIV-1 infection (CD4 over 450/µl and plasma HIV1-RNA below 200 cp/ml) under HAART, over a 96-week study period.
The study hypothesis is that intermittent therapy is not inferior to continuous therapy in maintaining a CD4 cell above 300/µl. It will compare the proportions of and time to immunological failure (CD4 count below 300/µl confirmed by a retest 14 days later) in the IT and CT groups.
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-1 infection
- •CD4 cell count over 450/µl for at least 6 months prior to screening
- •Plasma HIV1-RNA below 200 cop/ml for at least 6 months prior to screening
- •Stable and well tolerated ART for at least 6 months prior to screening
- •Acceptable methods of contraception
- •Patient able to comply with the protocol
- •Informed consent signed prior to (or at) screening
排除标准
- •CD4 nadir below 100/µl
- •Abacavir or nevirapine in the current ART
- •Hepatitis B with 3-TC, adefovir or tenofovir current therapy
- •Current or upcoming treatment with interferon for hepatitis B or C
- •History of AIDS-defining event in the 18 months prior to screening
- •Pregnancy or breast feeding
结局指标
主要结局
Immunological failure, defined by a CD4 cell count below 300/µl confirmed by a retest 14 days later during the study
次要结局
- 1993 Centers for Disease Control (CDC) classification of HIV infection B or C events
- Proportions of patients with CD4 count over 450/µl at week 96
- Proportions of patients with plasma HIV load over 400 and 1000/ml thresholds
- Plasma and peripheral blood mononuclear cells (PBMC) HIV resistance patterns
- Proportions of patients withdrawing initial treatment strategy
- Assessment of lipodystrophy and metabolic abnormalities
- Antiretroviral therapy (ARTs) adherence assessment
- Quality of life assessment
- Cost impact of the strategies