Study to Determine the Concentrations of Raltegravir in Semen, the Seminal to Plasma Ratio of Raltegravir and the Variability in Seminal to Plasma Ratios Over the Raltegravir Dosing Period.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Seminal Concentrations of Raltegravir.
研究概览
简要总结
The objective of this study is to determine if concentrations of raltegravir in semen exceed the 50% and 95% inhibitory concentrations of HIV during the dose interval.
The secondary objective is to determine the extend of raltegravir penetration into semen by obtaining semen to plasma ratios across the dosing interval, to determine the area under the concentration time curve of raltegravir in semen, and to determine the variability in the penetration of raltegravir into the seminal compartment over the dosing period.
详细描述
The patient population will consist of 12 male HIV-positive patients who have been receiving stable antiretroviral therapy that includes raltegravir for a minimum of three months. Patients will be enrolled from one clinic in downtown Toronto and a hospital affiliated HIV specialty clinic in Ottawa, Ontario. Eligible patients will have evidence of full virologic suppression (HIV viral load < 50 copies/mL) at least one month prior to enrollment in the study. No changes will be made to the patients antiretroviral therapy during the course of the study.
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
- Male
- 接受健康志愿者
- 是
入选标准
- •HIV infected male
- •18 years old or older
- •on raltegravir twice daily as part of their antiretroviral regimen for at least 3 months prior to screening
- •viral load < 50 copies/mL at least one month prior to enrolling
- •able to read, understand and sign a written informed consent prior to initiation of the study
- •medically stable at the time of the study, with no evidence of acute illness
排除标准
- •having difficulty adhering to current antiretroviral therapy
- •patient is expected to have difficulties adhering with study protocol
- •patients with malignancy, or acute renal or liver disease
- •patient with active AIDS-defining illness
- •patient with any medical, psychiatric or other circumstance that may impede the provision of informed consent
- •patient with any of the following abnormalities at the time of screening:
- •hemoglobin < 85 g/L
- •absolute neutrophil count < 1000 cells/uL
- •platelet count < 50,000 cells/ microleter (uL)
- •aspartate aminotransferase (AST), alanine transaminase (ALT) or total bilirubin > 3 times the upper limit of normal
- •serum creatinine > 1.5 times upper limit of normal
- •patient receiving concomitant therapy with rifampin or St. John's wort
结局指标
主要结局
Seminal Concentrations of Raltegravir.
时间窗: 6 months
Determine if concentrations of raltegravir in semen exceed the 50% and 95% inhibitory concentrations of HIV during the dosing interval.
次要结局
- Seminal Distribution of Raltegravir(6 months)
- Semen to Plasma Raltegravir Concentrations(6 months)
- Semen to Plasma Distribution of Raltegravir(6 months)