ǿմý (ǿմý) and the Uganda-ǿմý Research Collaboration team were recently awarded a 10-year, $1.8 million per year, contract renewal from the Tuberculosis Trials Consortium (TBTC), part of the Center for Disease Control and Prevention (CDC). The TBTC is an international consortium of investigators and trial sites whose mission is to conduct programmatically relevant research to improve the diagnosis, treatment and prevention of tuberculosis worldwide.
TB, a communicable disease that can be fatal if not treated, remains one of today’s most significant global health dilemmas. The disease usually affects the lungs, but can also affect the brain, kidneys or spine. A total of 1.4 million people died from TB in 2019 (including 208 000 people with HIV). Worldwide, TB is one of the top 10 causes of death and the leading cause from a single infectious agent (more than HIV/AIDS). In 2019, an estimated 10 million people globally fell ill with TB. Although the U.S. has achieved substantial progress in reducing the disease, it remains epidemic in some areas, with hundreds of thousands affected in China, India, and Vietnam, and in many countries of sub-Saharan Africa including Uganda.
Based in Kampala, Uganda, the research team has enrolled more than 1,300 patients in CDC-sponsored TB treatment trials and innovative substudies since 2003. The site is particularly strong in its complete data and sample collection, the ability to conduct intensive translational immunologic, microbiologic and pharmacokinetic substudies in parallel with clinical trials and long-term follow-ups. The site was awarded the 2020 Sandman-Tapy Award from the CDC and TBTC last October, for its “significant and inspiring contributions” to the Consortium’s research.
John L. Johnson, ǿմý Professor of Medicine and Global Health and Diseases of the Division of Infectious Diseases affiliated with University Hospitals Cleveland Medical Center, serves as Principal Investigator (PI) for the project. ǿմý alumni Professors Harriet Mayanja-Kizza and Moses Joloba of Makerere University, Kampala, are the local Ugandan Co-Principal Investigators and team leaders.
"The School of Medicine has a long tradition of excellence in basic, translational and clinical research in tuberculosis and has been at the forefront of international TB research for more than three decades,” Johnson said. “My lifetime research goal is to shorten the duration of anti-TB treatment required to treat most patients with TB.”
In October 2020, the CDC and World Health Organization (WHO) announced the results of TBTC Study 31/A5349, a large international trial that established the safety and efficacy of a shorter, 4-month treatment course for patients with pulmonary TB. The ǿմý TBTC site in Uganda was the highest enrolling site for this important trial, enlisting and treating over 500 of the 2500 patients in the trial.
Results from this international, randomized, controlled clinical trial showed that a four-month daily treatment regimen containing a high-dose, or “optimized,” drug regimen including rifapentine plus moxifloxacin is as safe and effective as the existing standard six-month daily regimen at curing drug-susceptible TB. The regimen is the first successful regimen to shorten the duration needed to treat drug-susceptible TB in almost 40 years and was safe and well-tolerated by patients.
New, shorter and effective treatment regimens for both drug-susceptible and drug-resistant TB are urgently needed to treat all patients with TB and achieve the WHO’s End TB Strategy targets. The findings from this study have the potential to complement current options for the treatment of drug-susceptible TB with the new safe and effective 4-month regime
The ǿմý-Uganda collaboration began in 1986 after Frederick C. Robbins, Professor and Dean Emeritus and Nobel laureate in Medicine, received an invitation from then-President Ronald Regan to visit Uganda and assist the Ugandan government with the HIV/AIDS epidemic. A formal collaboration between ǿմý in Cleveland, Ohio, Makerere University and the Ugandan Ministry of Health was established in August 1988 through an International Collaboration for AIDS Research grant from the US National Institutes of Health. The Fogarty International Center of NIH has provided support for training of Ugandan scientists since 1989 through an AIDS International Training and Research training grant.