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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01009034
Recruitment Status : Completed
First Posted : November 6, 2009
Results First Posted : September 9, 2014
Last Update Posted : September 9, 2014
Sponsor:
Information provided by (Responsible Party):
Canadian Immunodeficiency Research Collaborative

Tracking Information
First Submitted Date November 5, 2009
First Posted Date November 6, 2009
Results First Submitted Date June 16, 2014
Results First Posted Date September 9, 2014
Last Update Posted Date September 9, 2014
Study Start Date October 2009
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 8, 2014)
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. ]
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.
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures
 (submitted: September 8, 2014)
  • 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 ]
    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 ]
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Concentrations of Maraviroc in the Semen of HIV-Infected Men
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.
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 Observational
Study Design 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 Maraviroc Concentrations in Semen
Intervention 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 Groups/Cohorts 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 Completed
Actual Enrollment
 (submitted: September 8, 2014)
14
Original Estimated Enrollment
 (submitted: November 5, 2009)
12
Actual Study Completion Date December 2012
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
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 < 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
Sex/Gender
Sexes Eligible for Study: Male
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT01009034
Other Study ID Numbers WS 353380
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Canadian Immunodeficiency Research Collaborative
Study Sponsor Canadian Immunodeficiency Research Collaborative
Collaborators Not Provided
Investigators Not Provided
PRS Account Canadian Immunodeficiency Research Collaborative
Verification Date September 2014