A clinical trial will examine an investigational drug's early bacteria-killing activity in patients newly diagnosed with drug-sensitive pulmonary tuberculosis. The clinical trial-sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health-is being led by researchers at the Tuberculosis Research Unit at Case Western Reserve University in Cleveland. The study to take place in Cape Town, South Africa, will enroll 75 men and women with TB ages 18 to 65, including individuals who are also infected with HIV but not yet taking antiretroviral treatment.
In 2011, 8.7 million people worldwide became infected with TB, and 1.4 million people died, according to the World Health Organization. Co-infection with TB causes one quarter of all deaths among those infected with HIV. South Africa has the highest TB infection rate in the world and accounts for 5 percent of the global TB burden. The country also has the highest TB/HIV co-infection rate, 73 percent.
"New, simplified treatments that cure TB infection more quickly are desperately needed," said NIAID Director Anthony S. Fauci, M.D. "It has been nearly 50 years since a new drug specifically developed for TB was licensed. This is a relatively small study, but we hope it yields insights into whether this investigational drug shows promise in people who are newly diagnosed with TB, as laboratory and earlier clinical safety trials indicate it might."
The clinical trial will assess the investigational TB drug developed by AstraZeneca, based in London. In laboratory testing, the drug proved active against a wide range of drug-sensitive and drug-resistant strains of Mycobacterium tuberculosis (Mtb), the bacterium that causes TB disease. In two preliminary human studies in the United States, testing multiple doses, the oral drug was generally well-tolerated. Some study participants experienced gastrointestinal and blood-related adverse events at higher doses, but these effects were reversible and not serious.