Genetic Predictors of Raltegravir Penetration Into Cerebrospinal Fluid

Phase 2

Completed

• Conditions: HIV Infections
• Interventions: Drug: Raltegravir

• Registration Number: NCT00729924
• Lead Sponsor: Vanderbilt University

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 Timeline

• Study Start: 2008-08
• Study First Submitted: 2008-08-04
• Study First Submitted QC: 2008-08-07
• Study First Posted: 2008-08-08
• Primary Completion: 2011-02
• Study Completion: 2011-08
• Results First Submitted: 2014-05-27
• Status Verified: 2015-03
• Results First Submitted QC: 2015-03-02
• Last Update Submitted: 2015-03-02
• Results First Posted: 2015-03-03
• Last Update Posted: 2015-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Open label oral raltegravir	Raltegravir	Raltegravir a single 400 mg pill taken orally every 12 hours for a total of 7 days.

Primary Outcome Measures

Name	Time	Method
Penetration of Raltegravir (RGV) Into Cerebrospinal Fluid (CSF) Based on Plasma Area-under-the-curve.	Day 7	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).

Secondary Outcome Measures

Name	Time	Method
Penetration of Raltegravir (RGV) Into Cerebrospinal Fluid (CSF) Based on Single Plasma Timepoint.	Day 7	This outcome was the ratio of the 4-hour CSF concentration value (ng/mL) to the 4-hour plasma concentration value (ng/mL).

Trial Locations

Locations (1)

Vanderbilt Therapeutics Clinical Research Site; 🇺🇸 Nashville, Tennessee, United States