Clinical Trials

The Union has played an active role in TB research since the early 1960s, when it participated in the first international collaborative clinical trial that validated Sir John Crofton's "Edinburgh method" as the gold standard for TB treatment. Subsequent trials studied the efficacy of chemotherapy in previously untreated patients, the reliability of chest X-ray reading and reporting, sputum-smear microscopy, BCG adverse reactions, self-administered versus supervised treatment regimens and other issues.

 

The Union established the Clinical Trials Division in 1996 to a) initiate and conduct trials of new drugs and/or combined regimens for tuberculosis treatment, b) develop a strong international network of clinical trial centres and c) ensure the ability of its centres to conduct trials meeting the requirements of Good Clinical Practices (GCP) and Good Laboratory Practices (GLP).

 

In addition, a network of laboratory experts was established to assess and monitor the quality of the laboratories participating in trials. It is expected that the technical and professional capacity developed through these trials will have a lasting impact on the technical knowledge and skills available in the countries to test and implement new TB care and treatment technologies as they become available.

 

Currently, The Union has two clinical trials underway, and it is a collaborator in several proposals that have been submitted to donor bodies for funding.

  • ANRS 12150 Study (underway)

    Pharmacokinetics of Rifabutin Combined with Antiretroviral Therapy in the Treatment of Tuberculosis Patients with HIV Infection Up until now there has been a lack of randomised controlled trials to determine the optimal combination of anti-TB and antiretroviral (ARV) drugs for treating patients with both TB and HIV – a process that is fraught with difficulties due to drug-drug interactions, cumul...

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  • STREAM to test a 9-month MDR-TB treatment regimen (underway)

    The Union's evaluation of a standardised treatment regimen of anti-tuberculosis drugs for patients with multiple drug-resistant tuberculosis or STREAM will seek to determine whether a 9-month regimen developed and implemented by the Damien Foundation and the Institute of Tropical Medicine, and used with notable success in Bangladesh, can be used in different settings with comparable results.

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  • Study C (results published 2011)

    Before this trial, no clinical data existed to suggest that 4-drug combined tablets are as effective in the treatment of TB as separate tablets, even though the WHO and The Union recommend the use of fixed-dose combinations in general. Study C was therefore designed as an international multicentre trial to compare the efficacy, acceptability and toxicity of combined tablets versus separate tablets...

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  • Study A (results published in 2004)

    Study A, which ran from March 1998 through December 2001, was an international multicentre trial to compare two 8-month chemotherapy treatment regimens against the "gold standard" 6-month regimen for newly diagnosed pulmonary tuberculosis.   The results of this study, which were published in The Lancet in 2004, demonstrated that both of the 8-month regimens were inferior to the standar...

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