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
Results First Received: June 16, 2014  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Maraviroc Concentrations in Semen
Intervention: Other: Measuring semen samples

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
10 Male HIV-positive Patients

Male HIV-positive patients who have been receiving stable antiretroviral therapy that includes maraviroc for a minimum of three months.

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.


Participant Flow:   Overall Study
    10 Male HIV-positive Patients  
STARTED     14  
COMPLETED     10  
NOT COMPLETED     4  
Lost to Follow-up                 2  
Withdrawal by Subject                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
10 HIV+ men on maraviroc with VL <50 copies per M

Reporting Groups
  Description
10 Male HIV-positive Patients

Male HIV-positive patients who have been receiving stable antiretroviral therapy that includes maraviroc for a minimum of three months.

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.


Baseline Measures
    10 Male HIV-positive Patients  
Number of Participants  
[units: participants]
  14  
Age  
[units: years]
Median ( Inter-Quartile Range )
  51  
  ( 46 to 57 )  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     14  
>=65 years     0  
Gender  
[units: participants]
 
Female     0  
Male     14  
Region of Enrollment  
[units: participants]
 
Canada     14  



  Outcome Measures
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1.  Primary:   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. ]

2.  Secondary:   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 ]

3.  Secondary:   Determine the Area Under the Concentration Time Curve of Maraviroc in Semen.   [ Time Frame: 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Tony Antoniou
Organization: Maple Leaf Research
phone: 4164657936
e-mail: tantoniou@smh.toronto.on.ca


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