Towards Eradication: Reducing Proviral HIV DNA With Interferon-a Immunotherapy
试验速览
- 阶段
- 2 期
- 入组人数
- 54
- 试验地点
- 3
- 主要终点
- Integrated HIV proviral DNA
研究概览
简要总结
The purpose of this study is to determine if treatment with pegylated interferon alpha 2b (peg-IFN-α2b) will reduce the amount of integrated HIV DNA in peripheral blood cells and tissues of individuals with chronic HIV infection receiving antiretroviral treatment (ART).
A reduction and/or clearance of the latent viral reservoir (i.e.: virus that remains dormant in HIV-infected subjects receiving suppressive treatment ) is considered essential for HIV eradication.
By measuring the changes in integrated proviral HIV DNA, which is considered a surrogate measure of the latent reservoir, the investigators will establish if peg-IFN-α2b treatment should be considered as a component of future viral eradication strategies.
详细描述
Our long-term goal is to evaluate the effect of pegylated interferon (peg-IFN) α as an anti-HIV reservoir immunotherapy that could potentiate eradication strategies against HIV.
The present study is a 3-arm randomized clinical trial (RCT). The aim of this study is to determine whether a 20-week treatment course with 1μg/kg/week of pegylated interferon alpha 2 b (peg-IFN-α2b) will reduce the levels of HIV-1 proviral DNA levels in circulating PBMC and mucosa-associated lymphoid tissue (MALT) in HIV-infected individuals receiving long-term ART.
In addition, we will study if a 4-week interruption of ART is necessary to observe any change in proviral DNA levels.
In our previous study (NCT00594880) with a different form of Interferon alpha (peg-IFN-α2a), we observed a reduction in proviral DNA in peripheral blood cells in 50% of the patients. However, we did not measure the levels in MALT, and we could not determine whether or not an interruption of ART was necessary. The present study will address these questions.
We will also seek to determine the biological mechanisms (such as an increase in Natural Killer cell cytotoxicity) that mediate the antiviral effects of peg-IFN-α.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Conditional 12-week ART interruption
18 participants will receive peg-IFN-α2b (1 μg/kg/week) for 20 weeks.
干预措施: Peg-IFN-α2b (Drug)
Continuous ART
18 participants will receive peg-IFN-α2b (1 μg/kg/week) for 20 weeks.
干预措施: Peg-IFN-α2b (Drug)
结局指标
主要结局
Integrated HIV proviral DNA
时间窗: 24 weeks
The study endpoint is the change in the number of copies of integrated HIV DNA/10\^6 CD4+ T cells (as assessed by Alu-HIV gag PCR) between baseline and 20 weeks of peg-IFNα-2b administration (study week 24).
次要结局
- Integrated proviral DNA in tissue(24 weeks)
- CD4 count(24 weeks)
- Viral load(24 weeks)
研究者
Luis Montaner
Professor, Immunology Program and Director, HIV-1 Immunopathogenesis Laboratory
The Wistar Institute