Concentrations of Maraviroc in the Semen of HIV-Infected Men - Full Text View

Sponsor:	Canadian Immunodeficiency Research Collaborative
Information provided by:	Canadian Immunodeficiency Research Collaborative
ClinicalTrials.gov Identifier:	NCT01009034

Purpose

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 raltegravir dosing period.

Condition	Intervention
Maraviroc Concentrations in Semen	Other: Measuring semen samples

Study Type:	Observational
Study Design:	Cohort, 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.

Resource links provided by NLM:

MedlinePlus related topics: AIDS

Drug Information available for: Maraviroc

U.S. FDA Resources

Further study details as provided by Canadian Immunodeficiency Research Collaborative:

Estimated Enrollment:	12
Study Start Date:	October 2009
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

12 HIV-positive males

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 < 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01009034

Locations

Canada, Ontario
Canadian Immunodeficiency Research Collaborative	Recruiting
Toronto, Ontario, Canada, M5B1L6
Contact: Roberta Halpenny 416-465-5370 rhalpenny@on.aibn.com

Sponsors and Collaborators

Canadian Immunodeficiency Research Collaborative

More Information

No publications provided

Responsible Party:	CIRC ( Canadian Immunodeficiency Research Collaborative )
Study ID Numbers:	WS 353380, NCT00520897
Study First Received:	November 5, 2009
Last Updated:	November 5, 2009
ClinicalTrials.gov Identifier:	NCT01009034 History of Changes
Health Authority:	Canada: Health Canada; United States: Food and Drug Administration

ClinicalTrials.gov processed this record on February 08, 2010