NCT01019044已完成不适用
Virologic and Immunologic Evaluation of the Deep Viral Reservoirs in HIV-1 Infected Patients With Long Term Viral Suppression
Objectif Recherche Vaccins SIDA1 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2009年5月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Quantification of the HIV-RNA plasma viral load using ultrasensible assay (limit of detection: 1 copy/ml)
研究概览
简要总结
Prospective study in HIV-1 infected patients with a plasma viral load below the limit of detection and stable for at least 5 years.
详细描述
Evaluation of the mucosal HIV reservoirs (HIV-DNA quantification and distribution of the infected T lymphocytes in the gut mucosa associated lymphoid tissue compared to the blood in HIV-1 infected patients under antiretroviral treatment with an undetectable plasma viral load below the 50 copies/ml limit of detection for at least 5 years).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 documented infection
- •HIV-1 plasma viral load measurable before antiretroviral treatment initiation
- •Patients treated with an antiretroviral combination containing a protease inhibitor and/or a non-nucleosidic reverse transcriptase inhibitor without any interruption since treatment initiation
- •Patients with a stable plasma viral load below the limit of detection (HIV-RNA < 50 copies/ml since January 2006 and/or HIV-RNA < 200 copies/ml during the anterior period) under antiretroviral treatment for at least 5 years and for at least 90 % of the measures
排除标准
- •Contraindication to the biopsy
- •No ability or willingness to provide informed consent
- •Concomitant treatment with antithrombotics or platelets antiaggregatory
- •Patients co-infected with HCV and or HBV
- •Patients who received an immunosuppressive treatment during 3 months prior enrollment (chemotherapy, radiotherapy, corticotherapy, splenectomy) or an immunotherapy during 5 years prior enrolment (IL-2, anti-HIV vaccine, IFN-alpha)
结局指标
主要结局
Quantification of the HIV-RNA plasma viral load using ultrasensible assay (limit of detection: 1 copy/ml)
时间窗: Single patient visit
次要结局
- Quantification of the HIV proviral DNA in the rectal mucosa biopsies and in the PPBMCs(Single patient visit)
- Quantitative, phenotypic and functional description of the long-term immune reconstitution in the rectal mucosa biopsies(Single patient visit)
- Quantification of HIV proviral DNA in the total CD4 lymphocytes(Single patient visit)
- Pharmacokinetics of the antiretroviral molecules in the rectal mucosa biopsies and in the blood(Single patient visit)
研究者
研究点 (1)
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