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Concentrations of Raltegravir in the Semen of HIV-Infected Men

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Canadian Immunodeficiency Research Collaborative
ClinicalTrials.gov Identifier:
NCT01045265
First received: January 8, 2010
Last updated: August 12, 2014
Last verified: August 2014
Results First Received: June 16, 2014  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: HIV
Intervention: Other: Seminal plasma pharmacokinetics

  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
Men on Raltegravir HIV-infected men on chronic therapy with raltegravir 400 mg per day as part of antiretroviral therapy regimen.

Participant Flow:   Overall Study
    Men on Raltegravir  
STARTED     16  
COMPLETED     16  
NOT COMPLETED     0  



  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.
The median age and baseline CD4+ T-cell count of the study participants were 48 years (IQR 42–53) and 450 cells/mm3 (IQR 289–585).

Reporting Groups
  Description
Men on Raltegravir Measuring semen samples: Measure semen sample concentrations, obtain semen to plasma ratios across the dosing interval, the area under the concentration time curve of raltegravir in semen, the variability in penetration of raltegravir into the seminal compartment over the dosing period.

Baseline Measures
    Men on Raltegravir  
Number of Participants  
[units: participants]
  16  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     16  
>=65 years     0  
Age  
[units: years]
Median ( Inter-Quartile Range )
  48  
  ( 42 to 53 )  
Gender  
[units: participants]
 
Female     0  
Male     16  
Region of Enrollment  
[units: participants]
 
Canada     16  
CD4 Count  
[units: cells/mm^3]
Median ( Inter-Quartile Range )
  450  
  ( 289 to 585 )  



  Outcome Measures
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1.  Primary:   Seminal Concentrations of Raltegravir.   [ Time Frame: 6 months ]

2.  Secondary:   Semen to Plasma Raltegravir Concentrations   [ Time Frame: 6 months ]

3.  Secondary:   Seminal Distribution of Raltegravir   [ Time Frame: 6 months ]

4.  Secondary:   Semen to Plasma Distribution of Raltegravir   [ 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: NCT01045265     History of Changes
Other Study ID Numbers: MISP35369
Study First Received: January 8, 2010
Results First Received: June 16, 2014
Last Updated: August 12, 2014
Health Authority: Canada: Health Canada
United States: Institutional Review Board