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

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

Detailed Description
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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.

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

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: Raltegravir


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Raltegravir<br>Raltegravir 400 mg tablets twice daily | Drug: Raltegravir<br>* 400 mg tablets twice daily during duration of trial<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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 | 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 | 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 | Units of raltegravir concentration for genital tract and plasma sample are ng/mL | 8-10 hours after raltegravir dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Raltegravir, pharmacokinetics, Treatment Experienced