Levels of Raltegravir in the Female Genital Tissue

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Caroline Mitchell, University of Washington
ClinicalTrials.gov Identifier:
NCT01327482
First received: March 30, 2011
Last updated: December 18, 2014
Last verified: December 2014
Results First Received: December 10, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Single Group Assignment;   Masking: Open Label
Condition: HIV
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 Healthy volunteers who had regular menses and were not on hormonal contraception

Participant Flow:   Overall Study
    Raltegravir  
STARTED     10  
COMPLETED     9 [1]
NOT COMPLETED     1  
Adverse Event                 1  
[1] The 10th participant completed 2/3 visits



  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 Healthy volunteers who had regular menses and were not on hormonal contraception

Baseline Measures
    Raltegravir  
Number of Participants  
[units: participants]
  10  
Age  
[units: years]
Mean (Standard Deviation)
  30  (8)  
Gender  
[units: participants]
 
Female     10  
Male     0  
Region of Enrollment  
[units: participants]
 
United States     10  



  Outcome Measures
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1.  Primary:   Tissue Raltegravir Concentrations   [ Time Frame: 7, 14, 21 days ]

2.  Secondary:   Plasma Raltegravir Concentrations   [ Time Frame: 7, 14, 21 days ]


  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 NOT 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.


Results Point of Contact:  
Name/Title: Dr. Caroline Mitchell
Organization: Massachusetts General Hospital
phone: 617-724-2182
e-mail: caroline.mitchell@mgh.harvard.edu


No publications provided


Responsible Party: Caroline Mitchell, University of Washington
ClinicalTrials.gov Identifier: NCT01327482     History of Changes
Other Study ID Numbers: 38681-D
Study First Received: March 30, 2011
Results First Received: December 10, 2014
Last Updated: December 18, 2014
Health Authority: United States: Institutional Review Board