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Genetic Predictors of Raltegravir Penetration Into Cerebrospinal Fluid

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
David Haas, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00729924
First received: August 4, 2008
Last updated: March 2, 2015
Last verified: March 2015
History of Changes
Results First Received: May 27, 2014  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Basic Science
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 400mg Orally Every 12 Hours for 7 Days. Raltegravir a single 400mg tablet taken orally every 12 hours for a total of 7 days.

Participant Flow:   Overall Study
    Raltegravir 400mg Orally Every 12 Hours for 7 Days.  
STARTED     40  
COMPLETED     40  
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.
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Reporting Groups
  Description
Raltegravir: 400mg Orally Every 12 Hours for 7 Days Raltegravir a single 400mg tablet taken orally every 12 hours for a total of 7 days.

Baseline Measures
    Raltegravir: 400mg Orally Every 12 Hours for 7 Days  
Number of Participants  
[units: participants]
 		  40  
Age  
[units: years]
Median (Inter-Quartile Range) 		  34.5  
  (26.8 to 45)  
Gender  
[units: participants]
 		 
Female     20  
Male     20  
Race (NIH/OMB)  
[units: participants]
 		 
American Indian or Alaska Native     0  
Asian     0  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     0  
White     40  
More than one race     0  
Unknown or Not Reported     0  
Region of Enrollment  
[units: participants]
 		 
United States     40  
Cerebrospinal Fluid Protein  
[units: mg/dL]
Median (Inter-Quartile Range) 		  33  
  (24 to 43)  
Weight  
[units: kilograms]
Median (Inter-Quartile Range) 		  74.6  
  (62.6 to 80.5)  
Body Mass Index  
[units: kilgrams/(meter squared)]
Median (Inter-Quartile Range) 		  24.0  
  (22.2 to 25.6)  
ABCB1 Genotype [1]
[units: participants]
 		 
C/C Genotype     20  
T/T Genotype     20  
[1] ABCB1 (rs1045642) C/C or T/T Genotype



  Outcome Measures
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1.  Primary:   Penetration of Raltegravir (RGV) Into Cerebrospinal Fluid (CSF) Based on Plasma Area-under-the-curve.   [ Time Frame: Day 7 ]
  Show Outcome Measure 1

2.  Secondary:   Penetration of Raltegravir (RGV) Into Cerebrospinal Fluid (CSF) Based on Single Plasma Timepoint.   [ Time Frame: Day 7 ]
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  Serious Adverse Events
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  Other Adverse Events
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  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
There were no limitations to this trial.


  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: David W. Haas, MD
Organization: Vanderbilt University
phone: 615-936-8594
e-mail: david.w.haas@vanderbilt.edu


Publications of Results:


Responsible Party: David Haas, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00729924     History of Changes
Other Study ID Numbers: 080536
Study First Received: August 4, 2008
Results First Received: May 27, 2014
Last Updated: March 2, 2015
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board