Concentrations of Maraviroc in the Semen of HIV-Infected Men (NCT01009034)

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Canadian Immunodeficiency Research Collaborative

ClinicalTrials.gov Identifier:

NCT01009034

First received: November 5, 2009

Last updated: June 4, 2012

Last verified: June 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	November 5, 2009
Last Updated Date	June 4, 2012
Start Date ^ICMJE	October 2009
Primary Completion Date	December 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT01009034 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Concentrations of Maraviroc in the Semen of HIV-Infected Men
Official Title ^ICMJE	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.
Brief 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.
Detailed Description	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.
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	12 HIV-positive males
Condition ^ICMJE	Maraviroc Concentrations in Semen
Intervention ^ICMJE	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.
Study Group/Cohort (s)	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. Intervention: Other: Measuring semen samples
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	12
Estimated Completion Date	December 2012
Primary Completion Date	December 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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 < 50 copies/mL at least one month prior to enrolling able to read, understand and sign a written informed consent prior to initiation of the study medically stable at the time of the study, with no evidence of acute illness Exclusion Criteria: having difficulty adhering to current antiretroviral therapy patient is expected to have difficulties adhering with study protocol patients with malignancy, or acute renal or liver disease patient with active AIDS-defining illness patient with any medical, psychiatric or other circumstance that may impede the provision of informed consent patient with any of the following abnormalities at the time of screening: hemoglobin < 85 g/L absolute neutrophil count < 1000 cells/uL platelet count < 50,000 cells/uL AST, ALT or total bilirubin > 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
Gender	Male
Ages	18 Years and older
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Canada

Administrative Information
NCT Number ^ICMJE	NCT01009034
Other Study ID Numbers ^ICMJE	WS 353380
Has Data Monitoring Committee	No
Responsible Party	Canadian Immunodeficiency Research Collaborative
Study Sponsor ^ICMJE	Canadian Immunodeficiency Research Collaborative
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Canadian Immunodeficiency Research Collaborative
Verification Date	June 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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