2024-513366-18-00招募中2 期
Phase II, multicenter, open-label, randomized, controlled, open-label clinical trial to eliminate the latent reservoir of HIV-1 by administration of high doses of antiretroviral drugs.
Fundacion Para La Investigacion Biomedica Del Hospital Universitario Ramon Y Cajal2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2024年9月9日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- - Latent cell reservoir size by measuring total and intact proviral DNA (IPDA).
研究概览
简要总结
To evaluate the variation in the size of the latent cellular reservoir of HIV-1 after reaching inhibitory tissue concentrations by administration of high doses of antiretroviral drugs.
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Follow-up
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Undetectable plasma viral load (<50 copies of HIV RNA in blood plasma) for at least 12 months prior to inclusion. ● Antiretroviral treatment with a triple regimen containing an integrase inhibitor. ● R5 viral tropism, determined in proviral DNA.
排除标准
- •Chronic Hepatitis B (HBsAg +) - Untreated chronic hepatitis C - Viral tropism X4
- •Impaired renal function (plasma creatinine >1.5 mg/dl, creatinine clearance <60 ml/min/1.73 m2).
- •Concomitant treatment with cytochrome CYP3A inducing or inhibiting drugs
结局指标
主要结局
- Latent cell reservoir size by measuring total and intact proviral DNA (IPDA).
- Latent cell reservoir size by measuring total and intact proviral DNA (IPDA).
次要结局
未报告次要终点
研究者
Itziar de Pablo Lopez de Abechuco
Scientific
Fundacion Para La Investigacion Biomedica Del Hospital Universitario Ramon Y Cajal
研究点 (2)
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