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Clinical research in tuberculosis (TB) is led through the International Consortium for Trials of Chemotherapeutic Agents in Tuberculosis (INTERTB), an established international collaborative programme created to evaluate the clinical and bacteriological outcomes of chemotherapeutic agents for the treatment of TB. The current focus of these clinical trials is the therapeutic dose of rifampicin and rifapentine.

INTERTB symposium

St George’s, University of London hosts the annual INTERTB symposium, attended by TB researchers from around the world.

The INTERTB 2019 Symposium will take place on Monday 9 September 2019.

Presentations from INTERTB 2018 can be viewed and downloaded here.

INTERTB projects

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RIFASHORT
Key information
  • Status: Recruiting

  • Phase: III

  • Dates: October 2016 - December 2020

  • Chief Investigator: Dr Amina Jindani

  • Key Collaborators: LSHTM, University of Leicester, University of Sussex

  • Locations: Botswana, Uganda, Peru, Bolivia, Nepal, Guinea and Mexico

  • Funding: MRC/ Wellcome Trust/ DfID

Project summary

The main aim of this trial is to identify a shorter and more effective treatment regime for pulmonary tuberculosis.

This international, multicentre, controlled clinical trial aims to examine whether the standard regimen of six months duration could be shortened by increasing the dose of one of the drugs given. It is hoped that a shorter regimen would improve compliance and result in greater cure rates and therefore possibly reduce the emergence of resistance to TB drugs.

Technical details

The RIFASHORT trial will compare the current standard treatment of six months duration with two different regimens of four months duration using a higher dose of one of the established TB drugs, rifampicin. Alongside the usual TB drugs, rifampicin will be given at 1,200 mg daily fixed dose in one arm and 1,800 mg daily fixed dose in the other.

We are assessing whether giving an increased dose of rifampicin to patients receiving the standard treatment for tuberculosis is safe and, when given for four months only, will also result in greater and faster killing of the tubercle bacillus in the lungs and result in relapse rates similar to those found in the WHO recommended standard six-month regimen.

The trial will also evaluate the role of high dose rifampicin in eliminating the persister bacilli and reducing the relapse rates after cessation of treatment.

Contact

Claire Robb

RIFAQUIN
Key information
  • Status: Published 

  • Phase: III 

  • Dates: August 2008 – Feb 2013 

  • Chief Investigator: Dr Amina Jindani

  • Key Collaborators: MRC CTU 

  • Locations: South Africa, Zambia, Botswana and Zimbabwe

  • Funding: EDCTP

Project summary

In this trial, we assessed whether two newer drugs (rifapentine and moxifloxacin), when given together, can shorten or simplify treatment duration in order to improve overall patient adherence and therefore outcome.

This international, multicentre, controlled clinical trial assessed two different treatment regimens against the standard six month treatment for TB. One arm had a duration of four months and included the two newer drugs given on a twice weekly basis in the last two months. The other had a duration of six months with the two newer drugs given once-weekly in the last four months.

Results

The four-month regimen with a twice-weekly continuation phase gave disappointing results; relapse rates were significantly higher than those in the six-month control regimen.

However, the six-month regimen was as effective as the control regimen. It offers the prospect of a new regimen requiring considerably fewer days of treatment in the two month continuation phase, which was administered once-weekly, as compared to the control regimen, which was given daily throughout the treatment.

This six-month regimen could have an impact on the burden for both patients and National TB programs as it requires less treatment and administration time.

Read the published results.

RIFATOX
Key information
  • Status: Published 

  • Phase: IIB

  • Dates: Feb 2011 – May 2013 

  • Chief Investigator: Dr Amina Jindani

  • Locations: Uganda, Bolivia, Nepal 

  • Funding: St George's, University of London and Epicentre-MSF (Uganda)

Project summary

The main aim of the RIFATOX trial was to evaluate whether increasing the dose of one of the drugs used to treat TB, rifampicin, is safe and tolerated by patients.

The trial consisted of three arms, assessing the standard treatment of six months duration against two trial arms of increased rifampicin for four months followed by standard treatment for two months. In one trial arm rifampicin was increased to 15 mg/kg daily and in the other arm to 20 mg/kg daily.

Results

The trial concluded that the increased dose of rifampicin was safe and well tolerated. The trial has been used to inform the development of RIFASHORT (see above).

Read the published results.

 

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