NCT00729924

Genetic Predictors of Raltegravir Penetration Into Cerebrospinal Fluid

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Vanderbilt University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	Raltegravir	400mg orally every 12 hours for 7 days

Timeline

• Start date: 2008-08-01
• Primary completion: 2011-02-01
• Completion: 2011-08-01
• First posted: 2008-08-08
• Last updated: 2015-03-03
• Results posted: 2015-03-03

Locations

1 site across 1 country: United States