TB Alliance: Putting science to work for a faster TB cure

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US Government HIV/AIDS Clinical Trial Sites to Accelerate Completion of Phase III TB Drug Trial

TB Alliance’s REMox TB program leverages ACTG sites to advance testing of improved TB treatments

(Durban, SOUTH AFRICA,) The TB Alliance today announced the launch of a collaboration with the National Institute of Allergy and Infectious Diseases’ (NIAID) AIDS Clinical Trial Group (ACTG) to conduct and help complete a Phase III clinical trial testing potentially faster-acting tuberculosis (TB) treatments. 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. The partnership between the NIAID’s ACTG and TB Alliance joins available resources with the urgent need for TB clinical research capacity to accelerate testing of new therapies that can benefit both the HIV/AIDS and TB communities.

TB and HIV/AIDS are sometimes called “the dual epidemic” because they can be fatally synergistic. TB is the leading infectious killer of people with HIV/AIDS, especially in sub-Saharan Africa. Globally, one-third of the 33 million people living with HIV/AIDS are also infected with the bacterium that causes TB. New and improved TB drugs are desperately needed to treat patients suffering from HIV/TB co-infection.

The TB Alliance is currently enrolling patients in REMox TB, a global Phase III clinical trial, which is testing two four-month moxifloxacin-containing treatment regimens for drug-sensitive (DS) TB against the standard six-month therapy. Moxifloxacin has the potential to be the first new drug to treat DS-TB in more than 40 years, offering the potential for a shorter therapy for the millions of TB and TB/HIV co-infected patients. In order to help increase trial capacity to complete enrollment in the trial, four ACTG clinical trials units will participate in REMox TB.

“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, TB Alliance. “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 4 new clinical trial sites that will participate in REMox TB are located in Africa, and include 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. Enrollment has begun in multiple sites in Durban and will expand to the other sites in coming months.

“The new and expanding commitment by the U.S. National Institutes of Health to apply 21st century science to one of humanity's oldest scourges, TB, by tackling the co-epidemics of HIV and TB where they are the worst, in many African settings, has the promise of accelerating progress against both diseases,” said Mark Harrington, Executive Director, Treatment Action Group. “Activists, people with TB or HIV, researchers, and providers all welcome the expanded involvement of the NIH-funded ACTG in studying new TB drugs and regimens, bringing closer the prospect that we can eliminate them both in this century.”

About the TB Alliance

The Global Alliance for TB Drug Development (TB Alliance) is a not-for-profit organization dedicated to finding faster-acting and affordable drug regimens to fight tuberculosis. Through innovative science and with partners around the globe, we aim to ensure equitable access to faster, better TB cures that will advance global health and prosperity. The TB Alliance operates with funding from the Bill & Melinda Gates Foundation, the United Kingdom Department for International Development, the United States Agency for International Development, the European Commission, and the United States Food and Drug Administration. For more information please visit www.tballiance.org.

About REMox TB and moxifloxacin

REMox TB is a three-arm global Phase III study to in which moxifloxacin substitutes for two different drugs in the current first-line standard TB therapy, ethambutol and isoniazid, and is administered for a total of four months. REMox TB will determine whether either of these two new, four-month regimens are not inferior to standard six-month therapy in terms of failure and relapse. The TB Alliance is conducting the REMox TB trial in partnership with Bayer Healthcare AG, the University College of London, and the Medical Research Council as well as other partners around the world in an effort to find shorter, faster-acting TB drugs.

Moxifloxacin is a fluoroquinolone - a subset of the quinolone class of antibiotics. Developed and marketed by Bayer HealthCare AG, moxifloxacin has demonstrated efficacy for the treatment of several acute respiratory and uncomplicated skin and soft tissue infections. It has been used more than 134 million patients, in 123 countries. Moxifloxacin is currently not registered to treat tuberculosis.