Concentrations of Raltegravir in the Semen of HIV-Infected Men

Completed

Brief Summary: The objective of this study is to determine if concentrations of raltegravir in semen exceed the 50% and 95% inhibitory concentrations of HIV during the dose interval.

The secondary objective is to determine the extend of raltegravir penetration into semen by obtaining semen to plasma ratios across the dosing interval, to determine the area under the concentration time curve of raltegravir in semen, and to determine the variability in the penetration of raltegravir into the seminal compartment over the dosing period.

Detailed Description: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Raltegravir treated men	Seminal plasma pharmacokinetics	Single group study of seminal plasma pharmacokinetics of raltegravir in men receiving chronic raltegravir therapy

Primary Outcome Measures

Name	Time	Method
Seminal Concentrations of Raltegravir.	6 months	Determine if concentrations of raltegravir in semen exceed the 50% and 95% inhibitory concentrations of HIV during the dosing interval.

Secondary Outcome Measures

Name	Time	Method
Seminal Distribution of Raltegravir	6 months	Determine the area under the concentration time curve of raltegravir in semen.
Semen to Plasma Raltegravir Concentrations	6 months	Determine the extent of raltegravir penetration into semen by obtaining semen to plasma ratios across the dosing interval.
Semen to Plasma Distribution of Raltegravir	6 months	Determine the variability in the penetration of raltegravir into the seminal compartment over the raltegravir dosing period.