Clinical Trials Begin for Experimental TB Drugs in South Africa

November 13, 2007

Researchers this month are scheduled to begin recruiting volunteers in South Africa to participate in an international clinical trial to test the effectiveness of the antibiotic moxifloxacin in treating TB, Business Day reports.

The drug trial, which is called REMoxTB, is set to involve more than 2,000 volunteers and begin Phase III clinical trials in Kenya, South Africa, Tanzania and Zambia.

Global Alliance for TB Drug Development and Bayer Healthcare are conducting the trial. The study will be led by researchers from the British Medical Research Council and University College London.

Researchers for four months will use moxifloxacin in place of ethambutol or isoniazid in the otherwise standard four-drug TB regime and then assess the results.

Mel Spigelman, director of research and development for the TB Alliance, said the trial is expected to conclude by early 2011. "The World Health Organization will need to be involved in recommending the regimen and countries will have to move to introduce it, which will not be an easy task," he said.

The drug PA-824 also is in Phase II trials in Cape Town to assess whether it can effectively control TB bacteria, according to Business Day. Results are expected early next year.

Researchers will test the drug in 60 people with newly diagnosed TB for 14 days and then compare its performance with people who took standard drugs.