Comparing Raltegravir Genital Tract Distribution in HIV-infected Men and Women

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Robert Dicenzo, University of Rochester
ClinicalTrials.gov Identifier:
NCT00745368
First received: September 1, 2008
Last updated: September 7, 2012
Last verified: September 2012
Results First Received: July 25, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Single Group Assignment;   Masking: Open Label
Condition: HIV Infections
Intervention: Drug: Raltegravir

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Raltegravir Raltegravir 400 mg tablets twice daily

Participant Flow:   Overall Study
    Raltegravir  
STARTED     19 [1]
COMPLETED     16 [2]
NOT COMPLETED     3  
Unable to provide sample                 3  
[1] Of the 28 subjects who enrolled, 19 participated in a study visit
[2] 3 male subjects were unable to provide a sample and are not included in the results



  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.
No text entered.

Reporting Groups
  Description
Raltegravir Raltegravir 400 mg tablets twice daily

Baseline Measures
    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]
Mean ± Standard Deviation
  47  ± 8.8  
Gender  
[units: participants]
 
Female     8  
Male     8  
Region of Enrollment  
[units: participants]
 
United States     16  



  Outcome Measures
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1.  Primary:   Raltegravir Male Genital Tract Concentration   [ Time Frame: 8-10 hours after raltegravir dose ]

2.  Primary:   Raltegravir Female Genital Tract Concentration   [ Time Frame: 8-10 hours after raltegravir dose ]

3.  Primary:   Male Paired Plasma Concentration   [ Time Frame: 8-10 hours after raltegravir dose ]

4.  Primary:   Female Paired Plasma Concentration   [ Time Frame: 8-10 hours after raltegravir dose ]

5.  Primary:   Male Time Since Last Dose   [ Time Frame: 8-10 hours after raltegravir dose ]

6.  Primary:   Female Time Since Last Dose   [ Time Frame: 8-10 hours after raltegravir dose ]

7.  Primary:   Male Genital Tract:Plasma Concentration Ratio   [ Time Frame: 8-10 hours after raltegravir dose ]

8.  Primary:   Female Genital Tract:Plasma Concentration Ratio   [ Time Frame: 8-10 hours after raltegravir dose ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats


  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 more than 60 days but less than or equal to 180 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: Robert DiCenzo
Organization: University of Rochester
phone: 518 694 7228
e-mail: rob.dicenzo@acphs.edu


No publications provided


Responsible Party: Robert Dicenzo, University of Rochester
ClinicalTrials.gov Identifier: NCT00745368     History of Changes
Other Study ID Numbers: 33113
Study First Received: September 1, 2008
Results First Received: July 25, 2012
Last Updated: September 7, 2012
Health Authority: United States: Institutional Review Board