Comparing Raltegravir Genital Tract Distribution in HIV-infected Men and Women
2012年9月7日 更新者:Robert Dicenzo、University of Rochester
The purpose of this research study is to determine how much raltegravir gets into the male and female genital tract.
研究概览
详细说明
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.
研究类型
介入性
注册 (实际的)
28
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
-
New York
-
Rochester、New York、美国、14642
- University of Rochester
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
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
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:Raltegravir
Raltegravir 400 mg tablets twice daily
|
400 mg tablets twice daily during duration of trial
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Raltegravir Male Genital Tract Concentration
大体时间:8-10 hours after raltegravir dose
|
8-10 hours after raltegravir dose
|
|
Raltegravir Female Genital Tract Concentration
大体时间:8-10 hours after raltegravir dose
|
8-10 hours after raltegravir dose
|
|
Male Paired Plasma Concentration
大体时间:8-10 hours after raltegravir dose
|
This sample was taken as close to the time of genital tract sample as possible
|
8-10 hours after raltegravir dose
|
Female Paired Plasma Concentration
大体时间:8-10 hours after raltegravir dose
|
This sample was taken as close to the time of genital tract sample as possible
|
8-10 hours after raltegravir dose
|
Male Time Since Last Dose
大体时间: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
|
8-10 hours after raltegravir dose
|
Female Time Since Last Dose
大体时间: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
|
8-10 hours after raltegravir dose
|
Male Genital Tract:Plasma Concentration Ratio
大体时间:8-10 hours after raltegravir dose
|
Units of raltegravir concentration for genital tract and plasma sample are ng/mL
|
8-10 hours after raltegravir dose
|
Female Genital Tract:Plasma Concentration Ratio
大体时间:8-10 hours after raltegravir dose
|
Units of raltegravir concentration for genital tract and plasma sample are ng/mL
|
8-10 hours after raltegravir dose
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2008年9月1日
初级完成 (实际的)
2011年6月1日
研究完成 (实际的)
2011年6月1日
研究注册日期
首次提交
2008年9月1日
首先提交符合 QC 标准的
2008年9月2日
首次发布 (估计)
2008年9月3日
研究记录更新
最后更新发布 (估计)
2012年10月10日
上次提交的符合 QC 标准的更新
2012年9月7日
最后验证
2012年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
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