Comparing Raltegravir Genital Tract Distribution in HIV-infected Men and Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Male Genital Tract:Plasma Concentration Ratio
研究概览
简要总结
The purpose of this research study is to determine how much raltegravir gets into the male and female genital tract.
详细描述
Although we have many medications to fight the HIV virus, very little is known about how much of these medications get into the genital tract. Raltegravir is a new HIV medication that blocks HIV growth and lowers the amount of virus in the blood in a way that is different than all other currently available HIV medications. Raltegravir was recently approved by the Food and Drug Administration (FDA) for use in HIV infected patients, but there is very little information concerning how much raltegravir will reach the genital tract of men or women. The purpose of this research study is to determine how much raltegravir gets into the male and female genital tract.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Documentation of blood seropositive for HIV based on self report and confirmed by ELISA and Western blot or detectable HIV RNA
- •Stable anti-retroviral regimen for at least 3 weeks prior to enrollment
- •Capable of giving informed consent
- •Age 18 years and older
排除标准
- •Neoplasms
- •Women who are pregnant or nursing
- •History or current evidence of any significant acute or chronic medical illness that in the opinion of the investigator would preclude the subject from safely participating in the study
- •Current use of phenobarbital, phenytoin, or rifampin
- •Any major surgery within 4 weeks of enrollment
- •Blood transfusion within 4 weeks of enrollment
- •Inability to tolerate oral medication
- •Inability to tolerate venipuncture, venous access, or genital tract sampling
- •History of recent (within 6 months) drug or alcohol abuse
- •Evidence of organ dysfunction or any clinically significant deviation from normal in the medical history, physical examination, vital signs, and or clinical laboratory determinations that in the opinion of the investigator would preclude the subject from safely participating in the study
- •Any other sound medical, psychiatric and or social reason for exclusion as determined by the investigator
- •History of allergy to study medication or related compounds
研究组 & 干预措施
Raltegravir
Raltegravir 400 mg tablets twice daily
干预措施: Raltegravir (Drug)
结局指标
主要结局
Male Genital Tract:Plasma Concentration Ratio
时间窗: 8-10 hours after raltegravir dose
Units of raltegravir concentration for genital tract and plasma sample are ng/mL
Female Time Since Last Dose
时间窗: 8-10 hours after raltegravir dose
This measure describes the amount of time that expired between when the dose was administered and when the sample was taken
Raltegravir Male Genital Tract Concentration
时间窗: 8-10 hours after raltegravir dose
Raltegravir Female Genital Tract Concentration
时间窗: 8-10 hours after raltegravir dose
Male Paired Plasma Concentration
时间窗: 8-10 hours after raltegravir dose
This sample was taken as close to the time of genital tract sample as possible
Female Paired Plasma Concentration
时间窗: 8-10 hours after raltegravir dose
This sample was taken as close to the time of genital tract sample as possible
Male Time Since Last Dose
时间窗: 8-10 hours after raltegravir dose
This measure describes the amount of time that expired between when the dose was administered and when the sample was taken
Female Genital Tract:Plasma Concentration Ratio
时间窗: 8-10 hours after raltegravir dose
Units of raltegravir concentration for genital tract and plasma sample are ng/mL
次要结局
未报告次要终点
研究者
Robert Dicenzo
Adjunct Assistant Professor of Medicine
University of Rochester