The purpose of this research study is to determine how much raltegravir gets into the male and female genital tract.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Masking
NONE
Enrollment
28
400 mg tablets twice daily during duration of trial
University of Rochester
Rochester, New York, United States
Raltegravir Male Genital Tract Concentration
Time frame: 8-10 hours after raltegravir dose
Raltegravir Female Genital Tract Concentration
Time frame: 8-10 hours after raltegravir dose
Male Paired Plasma Concentration
This sample was taken as close to the time of genital tract sample as possible
Time frame: 8-10 hours after raltegravir dose
Female Paired Plasma Concentration
This sample was taken as close to the time of genital tract sample as possible
Time frame: 8-10 hours after raltegravir dose
Male Time Since Last Dose
This measure describes the amount of time that expired between when the dose was administered and when the sample was taken
Time frame: 8-10 hours after raltegravir dose
Female Time Since Last Dose
This measure describes the amount of time that expired between when the dose was administered and when the sample was taken
Time frame: 8-10 hours after raltegravir dose
Male Genital Tract:Plasma Concentration Ratio
Units of raltegravir concentration for genital tract and plasma sample are ng/mL
Time frame: 8-10 hours after raltegravir dose
Female Genital Tract:Plasma Concentration Ratio
Units of raltegravir concentration for genital tract and plasma sample are ng/mL
Time frame: 8-10 hours after raltegravir dose
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