The effect of intermittent rifampicin on raltegravir (RIF RAL)

• Research type

  Research Study

• Full title

  A single arm, 3 phase study to determine the effect of intermittent dosing of rifampicin on the pharmacokinetics of raltegravir in healthy volunteers

• IRAS ID

  77004

• Sponsor organisation

  University of Liverpool

• Eudract number

  2010-021461-73

• Research summary

  HIV and TB co-infection is a common worldwide problem. Recent figures show that TB and HIV co-infection is increasing in Europe. TB infection is the only major AIDS related opportunistic infection that is a risk to the general population. It is therefore important to treat people who have both TB and HIV with effective medication.Giving both TB and HIV medication is complicated and problematic. The TB drug rifampicin causes the body to process HIV medication more quickly. This means that there is not enough of the HIV medication in the blood to work properly. There is now a new HIV medication called raltegravir. Previous studies have shown that rifampicin may stop raltegravir from working properly. In these studies rifampicin was taken every day. Often rifampicin is given as part of directly observed therapy (DOTS) usually 3 times a week. There are no previous studies that look at giving rifampicin 3 times a week along with daily raltegravir.This study aims to look at taking rifampicin 3 times a week with the standard dose and an increased dose of raltegravir. This is to find out the best dose of raltegravir to take when taking rifampicin 3 times a week. The study will be conducted in 18 healthy volunteers.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  11/NW/0461

• Date of REC Opinion

  23 Sep 2011

• REC opinion

  Further Information Favourable Opinion