Jing Bao
1National Institutes of Health, USA
Title: More is not better: The result from a US government sponsored multi-center randomized international clinical trial to prevent tuberculosis in HIV/AIDS population
Biography
Biography: Jing Bao
Abstract
Background: Tuberculosis (TB) and HIV/AIDS have been closely linked since the beginning of AIDS epidemic. TB is the most common co-infection and cause of death among the AIDS population. And yet, there isn’t rapid, accurate, and reliable diagnosis methodology for TB testing, especially in resource-limited countries. Treating HIV/AIDS patients with the available 4 TB drugs has been utilized in some African countries to manage AIDS patients that were potentially afflicted with TB not diagnosed. In order to evaluate this treatment/prevention strategy for such patient population, the Division of AIDS at the National Institute of Allergy and Infectious Diseases, one of the 27 institutes and Centers of the National Institutes of Health, funded / sponsored a multicenter international clinical trial project.
Methods: An open label, randomized clinical trial was conceived in 2008 and the first patient was enrolled in October 2011. The study has completed the last patient follow-up in June 2014. The protocol included two arms. Arm A has received standard anti-HIV treatment therapy plus four anti-TB drugs, isonizid (INH), Rifampin (RIF), pyrozinamide (PZA), and Ethambutol (EMB). Arm B has received standard anti-HIV treatment plus isoniazid, a WHO recommended strategy to prevent TB. All participants had CD4 counts less than 50 per μL.
Results & Conclusion: The trial enrolled 850 patients and conducted in 18 clinical trial sites in Malawi, South Africa, Haiti, Kenya, Zambia, India, Brazil, Zimbabwe, Peru, and Uganda. We hypothesized that the empirical treatment would reduce the mortality in this patient population. However, the results from the trial showed that the mortality rate was same for both study arms. Furthermore, the TB incident rates in Arm A were significantly higher in the treatment arm compared to control arm (33 versus 19). The results illustrated that adding RIF, PZA, and EMB were not helpful, and possibly harmful. Drug-drug interactions maybe one of the reasons and the real-time drug concentration tests are among the other measurements to explain these study results.