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

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ClinicalTrials.gov Identifier: NCT00745368
Recruitment Status : Completed
First Posted : September 3, 2008
Results First Posted : October 10, 2012
Last Update Posted : October 10, 2012
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Robert Dicenzo, University of Rochester

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label)
Condition: HIV Infections
Intervention: Drug: Raltegravir

  Participant Flow

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

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 
Overall Participants Analyzed 
[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

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

Measure Type Primary
Measure Title Raltegravir Male Genital Tract Concentration
Measure Description No text entered.
Time Frame 8-10 hours after raltegravir dose  

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

Measured Values
   Raltegravir 
Participants Analyzed 
[Units: Participants]
 		 8 
Raltegravir Male Genital Tract Concentration 
[Units: ng/mL]
Median (Inter-Quartile Range) 		 485.1 
 (428.5 to 753.3) 

No statistical analysis provided for Raltegravir Male Genital Tract Concentration



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

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

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

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

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

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

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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.


  More Information

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



Responsible Party: Robert Dicenzo, University of Rochester
ClinicalTrials.gov Identifier: NCT00745368     History of Changes
Other Study ID Numbers: 33113
First Submitted: September 1, 2008
First Posted: September 3, 2008
Results First Submitted: July 25, 2012
Results First Posted: October 10, 2012
Last Update Posted: October 10, 2012