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
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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
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.
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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
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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
Due to limited sample size and large intersubject variability, more study comparing male and female GT concentrations is needed.


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