The TB Alliance announced Tuesday that it has enlisted the help of the National Institute of Allergy and Infectious Diseases (NIAID) AIDS Clinical Trial Group (ACTG) to help complete testing of a potentially shorter tuberculosis treatment regimen utilizing an antibiotic not currently registered to treat TB – moxifloxacin.
The ACTG agreed to allow the TB Alliance to conduct and help complete “REMox TB” – a three-arm, global Phase III clinical trial investigating two, four-month treatment regimens for drug-sensitive TB. The treatments will switch out two different drugs in the current, first-line standard TB therapy – ethambutol and isoniazid – for the drug moxifloxacin, and then determine whether or not the new regimens are inferior to the standard treatment by looking at treatment failure and relapse rates. If approved, moxifloxacin would be the first drug newly approved to treat TB in 40 years.
“Few clinical trials for TB have been conducted under modern GCP/GCLP standards in the past 40 years, and the infrastructure to support invigorated global TB drug research is lacking, especially in resource-limited settings where the majority of TB cases are found,” according to a TB Alliance press release.
Four ACTG clinical trial sites in Africa will be used in the REMox trial: the UKZN-Durban International Clinical Trials Unit, UKZN‐CAPRISA‐HIV/AIDS CTU, and Soweto CTU at PHRU in South Africa; and the Center for Infectious Disease Research at the Kalingalinga ACTG Clinic in Zambia. Multiple sites in Durban have started enrollment, and other sites will begin enrollment in the next few months.
“This collaboration is a perfect example of how innovative and efficient resource sharing can benefit all parties involved–in this case, the TB and the HIV/AIDS community, and especially those co-infected with TB and AIDS,” said Dr. Mel Spigelman, President and CEO of TB Alliance, in the release. “With this collaboration, ACTG enhances our collective capacity to more quickly evaluate new TB drugs and regimens, which will result in improved therapies being available sooner for all TB patients, including those co-infected with HIV.”
The TB Alliance is conducting REMox TB in partnership with Bayer Healthcare AG, the University College of London, and the Medical Research Council along with other partners around the world.