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.
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 Type
OBSERVATIONAL
Enrollment
16
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 Ottawa Hospital
Ottawa, Ontario, Canada
Canadian Immunodeficiency Research Collaborative
Toronto, Ontario, Canada
Seminal Concentrations of Raltegravir.
Determine if concentrations of raltegravir in semen exceed the 50% and 95% inhibitory concentrations of HIV during the dosing interval.
Time frame: 6 months
Semen to Plasma Raltegravir Concentrations
Determine the extent of raltegravir penetration into semen by obtaining semen to plasma ratios across the dosing interval.
Time frame: 6 months
Seminal Distribution of Raltegravir
Determine the area under the concentration time curve of raltegravir in semen.
Time frame: 6 months
Semen to Plasma Distribution of Raltegravir
Determine the variability in the penetration of raltegravir into the seminal compartment over the raltegravir dosing period.
Time frame: 6 months
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