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NIH-funded trial launched to assess experimental TB drug
Date:12/11/2012

related adverse events at higher doses, but these effects were reversible and not serious.

To be eligible to participate in the new trial, patients must have newly diagnosed pulmonary TB as confirmed through a positive sample of mucus and saliva (sputum). HIV-infected patients who are not currently taking antiretrovirals and who have a CD4+ T-cell count of greater than 350 cells per cubic millimeter are eligible for the study. CD4+ T-cells are a key marker of immune system health.

Study volunteers will be randomly assigned to one of five study groups, each with 15 participants. In four groups, all participants will receive a 14-day regimen of the experimental drug, but at different dosages and frequencies: 500 milligrams (mg) once daily; 500 mg twice daily; 800 mg twice daily; and 1200 mg twice daily.

The study lasts only 14 days because of the potential risk of drug resistance emerging in TB patients receiving a single drug for a prolonged period of time.

Participants in the fifth study group will receive the standard TB treatment of 14 days of rifafoura four-drug combination pill containing isoniazid, rifampin, ethambutol and pyrazinamidedosed according to the study participants' body weight. After the 14-day study, all participants will receive standard TB drugs to treat their disease.

Researchers will examine daily sputum samples from the study participants to determine whether the investigational drug is reducing their TB bacteria counts, and if so, to what extent. Information about clinical trial NCT01516203 is available at http://www.clinicaltrials.gov. For more information about TB research, visit the NIAID Tuberculosis webpage'/>"/>

Contact: Sara Crocoll
niaidnews@niaid.nih.gov
301-402-1663
NIH/National Institute of Allergy and Infectious Diseases
Source:Eurekalert

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