NCT02269605已完成1 期
Bryostatin-1 Effect on HIV-1 Latency and Reservoir HIV-1 Infected Patients Receiving Antiretroviral Treatment: Pilot, Controlled, Double Blinded, Dose Searching Trial
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2014年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Intracellular HIV-1 RNA (usRNA and msRNA) level before and after bryostatin-1 administration
研究概览
简要总结
Phase I, randomized, double blind, placebo-controlled, dose-finding trial. The trial´s goal is to evaluate two different doses of Bryostatin on HIV-1 latency and reservoir in HIV-1 infected patients receiving antiretroviral treatment.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients understanding the trial purpose
- •Patients between 18 and 50 years of age
- •Patients with chronic HIV-1 infection
- •Patients receiving antiretroviral treatment with at least 3 active drugs for at least 2 years
- •Undetectable viral load measured by ultra sensitive methods
- •CD4+ levels higher than 350 cells/mm3
- •Patients committed to use contraceptive methods during the trial and up to 3 months after.
排除标准
- •Previous antiretroviral treatment failure, as any viral load outbreak after having had undetectable HIV-1 load. Low grade, transitory outbreaks (<200 RNA copies/ml) resolved without treatment modifications are excluded
- •Patients planned to interrupt antiretroviral treatment during the trial
- •Patients receiving immunosuppressant or immunostimulant drugs, including valproic acid.
- •Pregnant women
- •Bryostatin-1 hypersensitivity
- •Being enrolled in another clinical trial or having participated in another clinical trial in the previous 3 months.
研究组 & 干预措施
Group 1
Placebo Comparator
Patients receiving placebo (sodium chloride) at single dose
干预措施: Placebo (Other)
Group 2
Active Comparator
Patients receiving Bryostatin 1 (10ug/m2) at single dose
干预措施: Bryostatin 1 (10ug/m2) (Drug)
Group 3
Active Comparator
Patients receiving Bryostatin 1 (20ug/m2) at single dose
干预措施: Bryostatin 1 (20ug/m2) (Drug)
结局指标
主要结局
Intracellular HIV-1 RNA (usRNA and msRNA) level before and after bryostatin-1 administration
时间窗: Baseline visit and days 2 and 3 after the day of treatment
次要结局
- Adverse Events(From baseline visit to day 28 after drug administration)
- HIV-1 RNA level(Baseline visit, day 0 (15, 30, 60 minutes after begining of drug administration and 1, 2, 4, 8, 12 hours after begining of drug administration) and days 1, 2 and 3)
- Episomal DNA with 2 LTRs level(Baseline visit, day 1 and day 3)
- CD4+ and CD8+ T (CD38+ and HLA DR+ positive) cell level(Baseline visit, day 1 and day 3)
研究者
研究点 (1)
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