Genetic Predictors of Raltegravir Penetration Into Cerebrospinal Fluid

Phase 2/3 Completed 40 enrolled Vanderbilt University

NaSingle-groupOpen-labelBasic science

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.

Timeline

Start: 2008-08
Primary completion: 2011-02
Completion: 2011-08

Outcome

Missed primary endpoint

registry p = 0.43; Wilcoxon (Mann-Whitney) NCT00729924 ↗

paper CSF raltegravir concentrations do not differ by ABCB1 3435C → T genotype but strongly correlate with plasma exposure. PMID 24349334 ↗

Publications

Results Johnson DH, Sutherland D, Acosta EP, Erdem H, Richardson D, Haas DW. Genetic and non-genetic determinants of raltegravir penetration into cerebrospinal fluid: a single arm pharmacokinetic study. PLoS One. 2013 Dec 11;8(12):e82672. doi: 10.1371/journal.pone.0082672. eCollection 2013.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Raltegravir	Other / unclassified	400 mg	Oral