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Genetic Predictors of Raltegravir Penetration Into Cerebrospinal Fluid

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ClinicalTrials.gov Identifier: NCT00729924
Recruitment Status : Completed
First Posted : August 8, 2008
Results First Posted : March 3, 2015
Last Update Posted : March 3, 2015
Sponsor:
Information provided by (Responsible Party):
David Haas, Vanderbilt University

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
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 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

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: 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 
Overall Participants Analyzed 
[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

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 ]
  Show Outcome Measure 2


  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
There were no limitations to this trial.


  More Information

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
First Submitted: August 4, 2008
First Posted: August 8, 2008
Results First Submitted: May 27, 2014
Results First Posted: March 3, 2015
Last Update Posted: March 3, 2015