NCT00334022已完成不适用
A Pilot Randomized Controlled Trial of Adding Enfuvirtide to Standard Combination Antiretroviral Therapy in HIV-infected Individuals With Full Virologic Suppression to Further Suppress Proviral HIV DNA
Canadian Immunodeficiency Research Collaborative1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2006年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- The change of proviral HIV-1 DNA in both purified resting and activated CD4 T cells from baseline to month 6.
研究概览
简要总结
In order to better understand the source(s) and the mechanism(s) of HIV persistence and to potentially lead to further suppression of HIV from viral reservoirs, we propose to examine the effect of co-administration of enfuvirtide, an entry inhibitor of HIV, on diminution of the size of the viral reservoir in infected individuals who are receiving effective antiviral therapy for extended periods of time (> 5 years).
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient must be HIV infected
- •Patient must be > 18 years old
- •Patient must be taking standard combination antiretroviral therapy with 2-3 NRTIs and 1-2 PIs or a NNRTIs for at least five years
- •Patient must have a viral load < 50 copies/mL (using the standard available methods of detection) during the entire time on standard combination antiretroviral therapy except for initial fall of viral load
- •Patient must have a CD4 count above 400 cells/mm3 in last 3 months
- •Female patient must agree to use two methods of birth control or abstinence during the period of the study
- •Patient has to have signed full informed consent
排除标准
- •Patient who would have difficulty participating in a trial due to non-adherence or substance abuse
- •Patient who have taken mono or dual antiretroviral therapy
- •Patient who have had a viral load > 50 copies/mL on any antiretroviral regimen
- •Patient with any of the following abnormal laboratory test results in screening:
- •Hemaglobin < 100 g/L
- •Neutrophil count < 750 cells/uL
- •Platelet count < 50,000 cells/L
- •AST or ALT > 5X the upper limit of normal
- •Creatinine > 250 umol/L
- •Patient with a malignancy
- •Patient with other significant underlying disease (non-HIV) that might impinge upon disease progression or death
- •Patient with an active AIDS-defining illnesses in the past six months
- •Patients who are pregnant
研究组 & 干预措施
Did not receive enfuvirtide
Placebo Comparator
patients were randomized to either receive enfuviratide or not receive it
干预措施: enfuvirtide (Drug)
enfuvirtide
Active Comparator
enfuvirtide 1ml BID
干预措施: enfuvirtide (Drug)
结局指标
主要结局
The change of proviral HIV-1 DNA in both purified resting and activated CD4 T cells from baseline to month 6.
时间窗: 6 months
The change of proviral HIV-1 DNA in both purified resting and activated CD4 T cells from baseline to month 6.
次要结局
- To determine the change of proviral HIV-1 DNA from baseline to month 3(3 months)
- To determine the change of proviral HIV-1 DNA from months 6 to 9 after the enfurvitide has been stopped for 3 months in the treatment arm(9 months)
- To quantify plasma HIV (limit of detection 2 copies/ml of plasma)(9 months)
- To quantify cell associated HIV RNA (unspliced and multiply spliced) in resting and activated CD4+ T cells(9 months)
- To determine the decay characteristics of HIV in resting CD4+ T cells by quantitative co-culture assays(9 months)
- To determine the half-life of HIV in resting CD4+ T cells(9months)
- To carry out phylogenetic analysis of HIV in the plasma, resting, and activated CD4+ T cell compartments(9 months)
- To quantify the amount of HIV in gastrointestinal-associated lymphoid tissue (GALT) by quantitative co-culture assays (as part of a sub-study - see GALT sub-study)(9 months)
研究者
研究点 (1)
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