Clinical research in tuberculosis (TB) is led through INTERTB, an established international consortium created to evaluate the clinical and bacteriological outcomes of chemotherapeutic agents for the treatment of TB.

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Globally, annual incidence of TB remains high at around 10 million cases with 1.5 million deaths per year. While rates in some countries are falling, the burden of TB is particularly high in low and middle-income countries, and routine treatment services do not always achieve the best cure rates.

The current treatment of TB involves taking drugs daily for six or eight months. Although the drugs are free to patients in low-income countries, this still involves a substantial cost. Patients often terminate productive/economic activity and this cost is often covered by selling assets or borrowing money.

Treatment services are also burdened by treatment supervision. If the length of treatment could be shortened to four months, or treatment administration simplified by, for example, being given once or twice weekly rather than daily, this would be of great benefit to both the patients and the treatment services.

INTERTB is responsible for designing and conducting randomized controlled clinical trials to shorten and simplify treatment of TB as well as developing a network of clinical trial centres across the world. The focus of these clinical trials is the dose rifampicin and rifapentine.

St George’s, University of London hosts the annual INTERTB symposium which is attended by TB researchers from around the world. The next symposium will be held on 17th November 2017. For more information please contact Dr Amina Jindani.

Presentations from INTERTB 2017 can be viewed and downloaded here.

Read more below to find out about previous and ongoing projects.

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 1200mg daily fixed dose in one arm and 1800mg 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 – This email address is being protected from spambots. You need JavaScript enabled to view it.

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: SGUL & 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 15mg/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.

World Without Tuberculosis

INTERTB is partly supported by World Without Tuberculosis (WWTB). WWTB is a London, UK based registered charity. Their mission is the global eradication of tuberculosis through the identification of safe and effective treatment regimens of very short durations. Please visit http://www.worldwithouttb.org/ to donate.


Last Updated: Monday, 12 March 2018 14:47