Concentrations of Raltegravir in the Semen of HIV-Infected Men
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Study to Determine the Concentrations of Raltegravir in Semen, the Seminal to Plasma Ratio of Raltegravir and the Variability in Seminal to Plasma Ratios Over the Raltegravir Dosing Period.|
|Study Start Date:||December 2009|
|Estimated Study Completion Date:||December 2012|
|Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
|12 male HIV-positive patients||
Other: Measuring semen samples
Measure semen sample concentrations, obtain semen to plasma ratios across the dosing interval, the area under the concentration time curve of raltegravir in semen, the variability in penetration of raltegravir into the seminal compartment over the dosing period.
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.
|The Ottawa Hospital|
|Ottawa, Ontario, Canada|
|Canadian Immunodeficiency Research Collaborative|
|Toronto, Ontario, Canada, M5B 1L6|