Concentrations of Maraviroc in the Semen of HIV-Infected Men (NCT01009034)
The objective of this study is to determine if concentrations of maraviroc in semen exceed the 50% and 95% inhibitory concentrations of HIV during the dose interval.
The secondary objective is to determine the extent of maraviroc penetration into semen by obtaining semen to plasma ratios across the dosing interval, to determine the area under the concentration time curve of maraviroc in semen, and to determine the variability in the penetration of maraviroc into the seminal compartment over the maraviroc dosing period.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Study to Determine the Concentrations of Maraviroc in Semen, the Seminal to Plasma Ratio of Maraviroc and the Variability in Seminal to Plasma Ratios Over the Maraviroc Dosing Period.|
|Study Start Date:||October 2009|
|Estimated Study Completion Date:||December 2012|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
12 male HIV-positive patients
Male HIV-positive patients who have been receiving stable antiretroviral therapy that includes maraviroc for a minimum of three months.
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 maraviroc in semen, the variability in the penetration of maraviroc into the seminal compartment over the raltegravir dosing period.
The patient population will consist of 12 male HIV-positive patients who have been receiving stable antiretroviral therapy that includes maraviroc 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, K1H 8L6|
|Canadian Immunodeficiency Research Collaborative|
|Toronto, Ontario, Canada, M5B1L6|