Genetic Predictors of Raltegravir Penetration Into Cerebrospinal Fluid
This study is being done to find out how much of the drug raltegravir (RGV) gets into cerebrospinal fluid (CSF), compared to how much get into the blood and to find out if normal changes in a certain gene in your body affects how much RGV gets into the CSF.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Official Title:||Genetic Predictors of Raltegravir Penetration Into Cerebrospinal Fluid|
- Penetration of Raltegravir (RGV) Into Cerebrospinal Fluid (CSF) Based on Plasma Area-under-the-curve. [ Time Frame: Day 7 ] [ Designated as safety issue: No ]The primary outcome for this study was the ratio of the 4-hour CSF concentration value (ng/mL) to the partial plasma area-under-the-curve 0-4h value (h*ng/mL).
- Penetration of Raltegravir (RGV) Into Cerebrospinal Fluid (CSF) Based on Single Plasma Timepoint. [ Time Frame: Day 7 ] [ Designated as safety issue: No ]This outcome was the ratio of the 4-hour CSF concentration value (ng/mL) to the 4-hour plasma concentration value (ng/mL).
|Study Start Date:||August 2008|
|Study Completion Date:||August 2011|
|Primary Completion Date:||February 2011 (Final data collection date for primary outcome measure)|
Experimental: Open label oral raltegravir
Raltegravir a single 400 mg pill taken orally every 12 hours for a total of 7 days.
400mg orally every 12 hours for 7 days
Other Name: MK-0518
The multidrug efflux transporter P-glycoprotein (P-gp) is expressed in the blood-brain barrier where it limits entry of substrate drugs into the central nervous system. Raltegravir (MK-0158), a new HIV-1 integrase inhibitor and potentially major addition to the therapeutic armamentarium against HIV, is a substrate for P-gp. Studies are warranted to elucidate the relevance of P-gp transport for raltegravir in the central nervous system.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00729924
|United States, Tennessee|
|Vanderbilt Therapeutics Clinical Research Site|
|Nashville, Tennessee, United States, 37204|
|Principal Investigator:||David W Haas, MD||Vanderbilt University|