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Concentrations of Raltegravir in the Semen of HIV-Infected Men

2014-08-27 03:16:47 | BioPortfolio

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.

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Conditions

Raltegravir Concentrations in Semen

Intervention

Measuring semen samples

Location

The Ottawa Hospital
Ottawa
Ontario
Canada
M5B 1L6

Status

Recruiting

Source

Canadian Immunodeficiency Research Collaborative

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:16:47-0400

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