Comparing Raltegravir Genital Tract Distribution in HIV-infected Men and Women

Not Applicable

Completed

Brief Summary: The purpose of this research study is to determine how much raltegravir gets into the male and female genital tract.

Detailed Description: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Raltegravir	Raltegravir	Raltegravir 400 mg tablets twice daily

Primary Outcome Measures

Name	Time	Method
Raltegravir Male Genital Tract Concentration	8-10 hours after raltegravir dose
Raltegravir Female Genital Tract Concentration	8-10 hours after raltegravir dose
Male Paired Plasma Concentration	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	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	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 Time Since Last Dose	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
Male Genital Tract:Plasma Concentration Ratio	8-10 hours after raltegravir dose	Units of raltegravir concentration for genital tract and plasma sample are ng/mL
Female Genital Tract:Plasma Concentration Ratio	8-10 hours after raltegravir dose	Units of raltegravir concentration for genital tract and plasma sample are ng/mL