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

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Rochester
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Raltegravir Potassium

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