Viewing Study NCT00729924



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Last Modification Date: 2024-10-26 @ 9:53 AM
Study NCT ID: NCT00729924
Status: COMPLETED
Last Update Posted: 2015-03-03
First Post: 2008-08-04

Brief Title: Genetic Predictors of Raltegravir Penetration Into Cerebrospinal Fluid
Sponsor: Vanderbilt University
Organization: Vanderbilt University

Study Overview

Official Title: Genetic Predictors of Raltegravir Penetration Into Cerebrospinal Fluid
Status: COMPLETED
Status Verified Date: 2015-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: 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
Detailed Description: 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None