Clinical trial NCT00745368: Comparing Raltegravir Genital Tract Distribution in HIV-infected Men and Women
Official title: Comparing Raltegravir Genital Tract Distribution in HIV-infected Men and Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: HIV
Raltegravir
pharmacokinetics
Treatment Experienced
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2008-09-03
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

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.

Eligibility criteria: 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

Primary outcomes:
measure: Raltegravir Male Genital Tract Concentration
timeFrame: 8-10 hours after raltegravir dose
measure: Raltegravir Female Genital Tract Concentration
timeFrame: 8-10 hours after raltegravir dose
measure: Male Paired Plasma Concentration
timeFrame: 8-10 hours after raltegravir dose
measure: Female Paired Plasma Concentration
timeFrame: 8-10 hours after raltegravir dose
measure: Male Time Since Last Dose
timeFrame: 8-10 hours after raltegravir dose
measure: Female Time Since Last Dose
timeFrame: 8-10 hours after raltegravir dose
measure: Male Genital Tract:Plasma Concentration Ratio
timeFrame: 8-10 hours after raltegravir dose
measure: Female Genital Tract:Plasma Concentration Ratio
timeFrame: 8-10 hours after raltegravir dose
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
References: