Investigational Drug for TB to be Focus of NIH-Sponsored Study in South Africa

A clinical trial in Cape Town, South Africa, sponsored by the National Institute of Allergy and Infectious Disease (NIAID), part of the National Institutes of Health (NIH), will examine an investigational drug’s early bacteria-killing activity in patients that are newly diagnosed with drug-sensitive pulmonary tuberculosis (TB). The study will consist of 75 men and women aged 18 to 65 who are infected with HIV but not taking antiretroviral treatment.

South Africa has the highest TB infection rate in the world and accounts for 5 percent of the globe’s TB cases, of which there were 8.7 million new infections and 1.4 million TB-attributed deaths in 2011. South Africa also has the world’s highest TB and HIV co-infection rate at 73 percent. The investigational drug was developed by AstraZeneca, which is based in London, England.

The clinical trial will study volunteers who are assigned to one of five study groups consisting of 15 participants. Four of the five groups will receive a 14 day regimen of the drug but at different dosages and frequencies, and the fifth group will received a standard TB treatment of a four drug combination pill for 14 days. After the study, all participants will receive standard TB drugs. Researchers will determine if the investigational drug reduces the TB bacteria counts in the participants.