Efficacy and Tolerability of an Antiretroviral Bi-Therapy in HIV Infected Patients With Multidrug Resistance
Efficacy and Tolerability of an Antiretroviral bi-Therapy in HIV-1 Infected Patients With Multidrug Resistant HIV ANRS 109 Vista Trial.
研究概览
详细说明
In patients with HIV multidrug resistance, maintaining a failing full-dose HAART regimen usually results in significant drug toxicity and in continued accumulation of resistance mutations that can preclude future therapeutic options. In contrast, treatment interruption provokes the reemergence of wild-type virus with full replicative and pathogenic capacity. The researchers investigated whether a calibrated reduction in drug pressure could stabilize the evolution and the pathogenic potential of resistant virus.
A prospective pilot study was conducted in patients receiving protease inhibitor-based HAART with a resistance genotype predicting less than two active drugs according to the 2002 ANRS algorithm, CD4 counts over or equal to 100/mm3 and plasma HIV RNA below or equal to 5 log/ml. The treatment was low-dose IDV/RTV (200/100 BID) and 3TC 150mg BID. IDV doses were adjusted at week 4 to ensure a Cmin of 250+/-100ng/ml, which, based on a panel of multi-PI resistant viruses, was calculated to yield an inhibitory quotient (Cmin/IC50) of 0.50. Primary end-points were over 25% decrease in CD4 counts (immunological failure-IF), or over 0.7 log increase in plasma HIV RNA (virological failure-VF) at two consecutive monthly visits during the 24-week study. Inclusions were to stop when the total number of failures (VF+IF) reached 7
研究类型
注册
阶段
- 阶段2
联系人和位置
学习地点
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Bobigny、法国、93009 cedex
- Service de Medecine Interne hopital Avicenne
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- HIV-1 infection confirmed by Western Blot
- Karnofsky score over or equal to 70
- CD4 over or equal to 200/mm3
- Plasma viral RNA over or equal to 10 000 copies/ml and below 100 000 copies/ml.
- Stability of plasma viral load and CD4-during the last 3 months
- failure of two antiretroviral regimens with 2 PI and one NNRTI
- New efficacy drug on genotype not available
- Treatment on hand with 3 antiretroviral drugs with one PI since 3 months.
- Written inform consent
- Pregnancy
Exclusion Criteria:
- Hemoglobin below 8g/dL
- Neutrophils below 750/mm3
- ASAT, ALAT over 5N
- Hepatic insufficiency (prothrombin below 50%)
- Acute opportunistic infection
- Immunotherapy
- Treatment with active antiretroviral regimen
- Treatment with enzyme inductor
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:非随机化
- 介入模型:单组作业
- 屏蔽:无(打开标签)
研究衡量的是什么?
主要结果指标
结果测量 |
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Decrease over 25% in CD4 counts (immunological failure-IF), or increase over 0.7 log in plasma HIV RNA (virological failure-VF) at two consecutive monthly visits during the 24-week study
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次要结果测量
结果测量 |
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死亡
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Development of an HIV-1-related AIDS defining event
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Change in CD4 cell count between baseline and week 24
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Change in plasma HIV-RNA level between baseline and week 4, week 8, week 12 and week 24
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Change in genotypic and phenotypic resistance between baseline and week 2
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合作者和调查者
调查人员
- 首席研究员:Odile Launay, MD、Hopital Avicenne,Bobigny, Service de Médecine Interne
研究记录日期
研究主要日期
学习开始
研究完成
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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