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International Consortium for Trials of Chemotherapeutic Agents in Tuberculosis (INTERTB)

The INTERTB Clinical Trials/Workshop Programmes

INTERTB has recently been awarded two grants by the European & Developing Countries Clinical Trials Partnership (EDCTP) within the mandate to carry out clinical trials and to strengthen capacity to participate in the trials by the participating centres.

The first grant is for the amount of €4,251,991 for a randomised controlled clinical trial entitled “An international multicentre controlled clinical trial to evaluate high dose rifapentine and a quinolone in the treatment of pulmonary tuberculosis (RIFAQUIN )”. The objectives of the trial are to determine whether a treatment regimen containing moxifloxacin substituted for isoniazid in the intensive phase, together with high dose rifapentine, can be administered once weekly in the continuation page and can shorten the duration of the continuation phase with a relapse rate not inferior to a standard control regimen based on rifampicin and isoniazid. Further, whether both test regimens will prevent the occurrence of rifamycin mono-resistance in relapsing HIV positive patients.

The trial, which will be over a period of 4 years, is expected to start enrolling patients after the first quarter on 2007 in 6 participating centres in Mozambique, Zambia, Zimbabwe and South Africa.

The primary objectives of the trial are two fold.

A preparatory meeting of the participating centres was held in Johannesburg in January, 2006. See meeting archives by clicking here.

The second EDCTP grant is for the amount of €30,000 and is for a workshop to establish a network of sites, in sub-Saharan Africa, to conduct clinical trials in tuberculosis and to build their capacity to participate in multicentre trials.

The workshop will take place at the Unit for Clinical and Biomedical TB Research of the South African Medical Research Council, Durban, South Africa on the 5th, 6th and 7th March, 2007. Participants will come from South Africa, Mozambique, Zambia, Zimbabwe, Nigeria, Republic of Benin and Republic of Guinea.

The workshop agenda will address the following topics:

  1. Framing the research question and preparing the protocol
  2. Statistical matters such sample size, significance, and power,
  3. Study procedures such as randomisation, enrolment, treatment and follow-up.
  4. Data management and reporting the results
  5. Laboratory procedures relevant to the TB programme's studies
  6. Human subjects protection as stipulated by the ICH GCP Guidelines
  7. Intellectual property rights.

For further information please contact :

Amina Jindani, MD, FRCP
Honorary Senior Lecturer
Dept of Cellular & Molecular Medicine
St. George's, University of London
Jenner Wing, Cranmer Terrace
London SW17 0RE, United Kingdom.
Tel: +44 020 8725 2810 - Fax: +44 020 8672 0234