Status:
COMPLETED
Comparing Raltegravir Genital Tract Distribution in HIV-infected Men and Women
Lead Sponsor:
University of Rochester
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
NA
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 growt...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00745368
Start Date
September 1 2008
End Date
June 1 2011
Last Update
October 10 2012
Active Locations (1)
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1
University of Rochester
Rochester, New York, United States, 14642