Concentrations of Raltegravir in the Semen of HIV-Infected Men

The patient population will consist of 12 male HIV-positive patients who have been receiving stable antiretroviral therapy that includes raltegravir for a minimum of three months. Patients will be enrolled from one clinic in downtown Toronto and a hospital affiliated HIV specialty clinic in Ottawa, Ontario. Eligible patients will have evidence of full virologic suppression (HIV viral load < 50 copies/mL) at least one month prior to enrollment in the study. No changes will be made to the patients antiretroviral therapy during the course of the study.

Inclusion criteria

• HIV infected male
• 18 years old or older
• on raltegravir twice daily as part of their antiretroviral regimen for at least 3 months prior to screening
• viral load < 50 copies/mL at least one month prior to enrolling
• able to read, understand and sign a written informed consent prior to initiation of the study
• medically stable at the time of the study, with no evidence of acute illness

Exclusion criteria

• having difficulty adhering to current antiretroviral therapy
• patient is expected to have difficulties adhering with study protocol
• patients with malignancy, or acute renal or liver disease
• patient with active AIDS-defining illness
• patient with any medical, psychiatric or other circumstance that may impede the provision of informed consent
• patient with any of the following abnormalities at the time of screening:
• hemoglobin < 85 g/L
• absolute neutrophil count < 1000 cells/uL
• platelet count < 50,000 cells/ microleter (uL)
• aspartate aminotransferase (AST), alanine transaminase (ALT) or total bilirubin > 3 times the upper limit of normal
• serum creatinine > 1.5 times upper limit of normal
• patient receiving concomitant therapy with rifampin or St. John's wort