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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Canadian Immunodeficiency Research Collaborative
ClinicalTrials.gov Identifier:
NCT01009034
First received: November 5, 2009
Last updated: September 8, 2014
Last verified: September 2014
  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 maraviroc dosing period.


Condition Intervention
Maraviroc Concentrations in Semen
Other: Measuring semen samples

Study Type: Observational
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.

Resource links provided by NLM:


Further study details as provided by Canadian Immunodeficiency Research Collaborative:

Primary Outcome Measures:
  • Semen to Plasma Ratio of HIV Concentration During the Dosing Interval for Dar, Evr, Mar & Ral. [ Time Frame: Semen samples were collected 30 minutes to 1 hour before the morning dose of medication (day 1), and then at hours 1, 2, 4, 8, and 12 postdrug ingestion on days 2-6. Blood samples were collected within 1 hour of the semen sample. ] [ Designated as safety issue: No ]
    We used a staggered sampling approach in which semen samples were produced by participants over several days at different sampling times relative to the morning dose of antiretrovirals. Specifi- cally, semen samples were collected 30 minutes to 1 hour before the morning dose of medication (day 1), and then at hours 1, 2, 4, 8, and 12 postdrug ingestion on days 2-6. We collected corresponding blood samples within 1 hour of the semen sample. For each participant a single value (the HIV concentration ratio) was calculated as the minimum HIV concentration in the semen over the minimum HIV concentration in the blood throughout the dosing interval.


Secondary Outcome Measures:
  • Determine the Extent of Maraviroc Penetration Into Semen by Obtaining Semen to Plasma Ratios Across the Dosing Interval [ Time Frame: Semen samples were collected 30 minutes to 1 hour before the morning dose of medication (day 1), and then at hours 1, 2, 4, 8, and 12 postdrug ingestion on days 2-6. Blood samples were collected within 1 hour of the semen sample ] [ Designated as safety issue: No ]
    For each participant, the Maraviroc penetration ratio was calculated as the maximum Maraviroc concentration in the semen over the maximum Maraviroc concentration in the blood throughout the dosing interval.

  • Determine the Area Under the Concentration Time Curve of Maraviroc in Semen. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 14
Study Start Date: October 2009
Study Completion Date: December 2012
Primary Completion Date: December 2011 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Canada, Ontario
The Ottawa Hospital
Ottawa, Ontario, Canada, K1H 8L6
Canadian Immunodeficiency Research Collaborative
Toronto, Ontario, Canada, M5B1L6
Sponsors and Collaborators
Canadian Immunodeficiency Research Collaborative
  More Information

No publications provided

Responsible Party: Canadian Immunodeficiency Research Collaborative
ClinicalTrials.gov Identifier: NCT01009034     History of Changes
Other Study ID Numbers: WS 353380
Study First Received: November 5, 2009
Results First Received: June 16, 2014
Last Updated: September 8, 2014
Health Authority: Canada: Health Canada
United States: Food and Drug Administration

ClinicalTrials.gov processed this record on October 23, 2014