ARNS 141 TIPI : A Pilot Trial to Assess the Ability of an Intermittent Antiretroviral Therapy in Maintaining an Immunological Stability in Antiretroviral naïve HIV Infected Adults, With CD4 Count Above 500/mm3
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- proportion of patients with mean CD4 count at M21 and M24 above or equal to the mean CD4 count at screening and inclusion, without experiencing a decrease below 400/mm3 throughout the study.
研究概览
简要总结
The primary objective of the trial is to assess the ability of an early and intermittent antiretroviral therapy in maintaining an immunological stability in antiretroviral naive HIV infected adults, to offer a potential alternative strategy to differed and continuous antiretroviral treatment.This is a 2-year phase II, open-label, multicentric "proof of concept" trial. The patients included are treated following a pulse-therapy scheme, i.e. 6-month periods with once daily boosted-PI based therapy in alternance with 6-month periods without antiretroviral therapy. The preferentially recommended treatment of the study is atazanavir boosted with ritonavir, associated with a fixed combination of abacavir and lamivudine or emtricitabine + tenofovir.The patients are closely followed to assess the efficacy and the tolerance of the strategy, with clinical, biochemical, immunological, virological and pharmacokinetic evaluations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •adult confirmed HIV-1 infection
- •no previous treatment with antiretroviral drugs or interleukin-2
- •CD4 count ≥ 500/mm3
- •no active opportunistic infection
- •written informed consent
排除标准
- •non barrier contraception in women of child bearing potential, pregnant or breastfeeding woman, pregnancy project within the next 2 years
- •HIV-2 infection (with or without HIV-1), recent HIV primary infection, resistance to trial drugs at study entry, Ag HBs+, HCV requiring specific therapy
- •previous history of cerebrovascular accident or coronary heart disease, splenectomy
- •previous CD4 count < 400/mm3
- •CD4 percentage < 15%
- •hemoglobin < 8 g/dl, neutrophils < 750/mm3, platelets < 100.000/mm3, creatinine clearance < 50 ml/mn, AST or ALT or total bilirubin > 3 ULN
研究组 & 干预措施
Intermittent treatment
6 months on antiretroviral treatment and 6 months off treatment
干预措施: Structured treatment interruption (Drug)
结局指标
主要结局
proportion of patients with mean CD4 count at M21 and M24 above or equal to the mean CD4 count at screening and inclusion, without experiencing a decrease below 400/mm3 throughout the study.
时间窗: M21 and M24
次要结局
- proportion of patients following the strategy of the trial and with AIDS related and non AIDS-related (cardiovascular, renal, hepatic, infectious, cancerous) serious clinical event(M12 and M24)
- number, type and time to AIDS and non AIDS-related serious clinical events(from week 0 to M24)
- number, type and time to clinical and biological events (whatever the grade of severity)(from week 0 to M24)
- existence and nature of HIV genotypic mutations associated with antiretroviral resistance(M9 and M24 and at any time visit in case of failure)
- proportion of patients having followed the strategy of the trial(from week 0 to M24)
- evolution of HIV RNA and HIV DNA throughout the study(from week 0 to M24 for RNA and each 6 months for DNA)
- Quality of life and observance (questionnaires)(QL each 6 months, observance at M1, M6, M13 and M18)