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

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.

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