N/A
N=14
Concentrations of Maraviroc in the Semen of HIV-Infected Men
Maraviroc Concentrations in Semen
Bottom Line
View on ClinicalTrials.gov: NCT01009034 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Sep 2014
Primary outcome: Primary: Semen to Plasma Ratio of HIV Concentration During the Dosing Interval for Dar, Evr, Mar & Ral. — 0.20; 0.16; 0.92; 4.32 Inhibitory concentration ratio
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Measuring semen samples (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Canadian Immunodeficiency Research Collaborative
- Primary completion
- Dec 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Semen to Plasma Ratio of HIV Concentration During the Dosing Interval for Dar, Evr, Mar & Ral. |
0.20; 0.16; 0.92; 4.32 | — |
| SECONDARY Determine the Extent of Maraviroc Penetration Into Semen by Obtaining Semen to Plasma Ratios Across the Dosing Interval |
0.62 | — |
| SECONDARY Determine the Area Under the Concentration Time Curve of Maraviroc in Semen. |
3.43 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- HIV infected male
- 18 years old or older
- on maraviroc twice daily as part of their antiretroviral regimen for at least 3 months prior to screening
- viral load 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
Data sourced from ClinicalTrials.gov (NCT01009034). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.