NCT00987948已完成2 期
Pilot Study of the Effect of Maraviroc Intensification on Peripheral Blood Monocyte HIV DNA Levels When Given to HIV-Infected Subjects Stable on Highly Active Antiretroviral Therapy With Undetectable Plasma HIV RNA
University of Hawaii1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2010年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Change From Baseline to 24 Weeks in HIV DNA (Log-10 Copies/10^6 Cells) as Measured by HIV DNA Within CD14+ Peripheral Blood Mononuclear Cells
研究概览
简要总结
High levels of HIV infection within blood monocyte/macrophages (a type of white cells in the bloodstream) increases risk of dementia in HIV-infected individuals. Maraviroc (Selzentry) is a HIV medication that works by blocking the entry of HIV in cells including monocytes/macrophages that use a receptor called CCR5. The study hypothesis is that the addition of Maraviroc to a HIV antiretroviral regimen in HIV-infected individuals with high levels of HIV-infected monocyte/macrophages will lead to a decrease in the levels of infected monocyte/macrophages and to decrease in brain inflammation as studied by magnetic resonance spectroscopy (MRS, a form of MRI study).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 infection as documented by ELISA and confirmed by either Western blot, HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA by RT-PCR or bDNA at any time prior to study entry.
- •Receipt of ARV medication uninterrupted for > 1 year leading up to the screening period with demonstrated HIV RNA < 50 copies/ml for a period of 1 year."
- •Willingness for both males and females of childbearing potential to utilize 2 effective contraception methods (2 separate forms, one of which must be an effective barrier method), be non-heterosexually active or have a an exclusive vasectomized partner from screening throughout the duration of the study treatment and for 30 days following the last dose of study drugs.
- •Age >18 years.
- •Ability and willingness to provide written informed consent
- •The following laboratory parameters documented within 30 days prior to study entry:
- •Hemoglobin >8.0
- •Absolute neutrophil count >500
- •Platelet count >40,000
- •AST (SGOT) and ALT (SGPT) <5 x ULN
- •Creatinine <1.5 x ULN
- •Lipase <2.0 x ULN
- •Estimated creatinine clearance > 60 mL/min.
- •HIV DNA within peripheral blood mononuclear cells > 100 copies/mL
- •Not currently receiving Maraviroc as part of ARV regimen
排除标准
- •Past or present HIV opportunistic infection of the brain, learning disability, head injury with prolonged loss of consciousness or cognitive sequelae, or other non-HIV risk factor that may impact cognitive performance.
- •Any factor that precludes MRI scan including presence of metal or exposure to metal work (e.g., metal grinder/worker) and claustrophobia
- •History of seizure disorder
- •History of myocardial infarction, angina, congestive heart failure, peripheral vascular disease, angioplasty or cardiac surgery
- •Current malignancy or history of past malignancies excluding basal cell CA
- •Any immunomodulator, HIV vaccine, or investigational therapy within 30 days of study entry.
- •Any vaccination within 30 days of study entry.
- •Requirement for acute therapy for other AIDS-defining illness or other serious medical illnesses (in the opinion of the site investigator) within 14 days prior to study entry.
- •Other chronic illnesses including diabetes, autoimmune diseases, and endocrinopathies, except subjects on stable physiologic replacement therapy for low testosterone or thyroid levels
- •Known hypersensitivity to Maraviroc
- •Any condition which, in the opinion of the investigator, would compromise the subject's ability to participate in the study
- •Current active substance or alcohol dependence
- •Pregnancy or breast-feeding, intent to become pregnant during the course of the study.
研究组 & 干预措施
Maraviroc
Experimental
干预措施: maraviroc (Selzentry) (Drug)
结局指标
主要结局
Change From Baseline to 24 Weeks in HIV DNA (Log-10 Copies/10^6 Cells) as Measured by HIV DNA Within CD14+ Peripheral Blood Mononuclear Cells
时间窗: Baseline to 24 weeks
Week 24 minus baseline
次要结局
- Change From Baseline to 24 Weeks in Neuropsychological Performance As Measured by Age- and Education-Adjusted Z-Scores(Baseline to 24 Weeks)
研究者
研究点 (1)
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