A5274: Reducing Early Mortality and Early Morbidity by Empiric Tuberculosis Treatment Regimens

Post Date: 
2011-10-01
Clinical Site(s): 
Country: 
Summary: 
Dr. Amita Gupta is Protocol Co-Vice Chair for this multinational clinical trial being conducted in Brazil, Haiti, Kenya, Malawi, Peru, South Africa, Uganda, Zambia, and Zimbabwe, and in India by the Baltimore-Washington-India Clinical Trials Unit, of which CCGHE is a member. 
 
People with HIV have a high chance of becoming infected with TB, especially when they live in areas where TB infection is common. It can be difficult to diagnose TB in people who need to start HIV treatment right away. Within about 6 months after starting HIV treatment, some of these people can become very sick with TB and can even die from it.
 
This study is being done in people who are starting HIV treatment and who live in areas where the TB infection rate is high. The purpose of this study is to test an experimental approach to TB treatment to see if it is better than the usual approach. The experimental approach is to start TB treatment at the same time as HIV treatment, even when TB infection has not been found. The usual approach is to start TB treatment only if TB infection is found.
 
In this study, half of the people will start TB treatment at the same time as they start their HIV treatment. The other half will start TB treatment only if TB infection is found.
 
The study will also test how safe and effective it is to start TB treatment at about the same time as HIV treatment even when TB infection has not been found. The study will collect information about diet, whether (and when) people in the study become sicker or die, how well their HIV is controlled, how they are feeling, how they are taking their medications, whether it matters where they live or what kind of HIV and TB care is standard, how many people are diagnosed with TB while in the study, and how the cost of the two treatment options on a national level could be compared.
Collaborators: 
  • UNC Project, Lilongwe, Malawi
  • University of North Carolina School of Medicine, Chapel Hill, NC 
  • Perelman School of Medicine at the University of Pennsylvania, PA 
  • Harvard University, Boston, MA 
  • GHESKIO, Port-au-Prince, Haiti
  • Kenya Medical Research Institute, Kisumu, Kenya
  • Clinical HIV Research Unit, Department of Medicine, University of Witwatersrand, Johannesburg, South Africa
  • Perinatal HIV Research Unit, University of Witwatersrand, Johannesburg, South Africa
  • Moi University School of Medicine, Eldoret, Kenya
  • Johns Hopkins Project, Blantyre, Malawi
  • Centre for the AIDS Programme of Research in South Africa, Durban, South Africa
  • University of Zimbabwe, Harare, Zimbabwe
  • Joint Clinical Research Centre, Kampala, Uganda
  • Centre for Infectious Diseases Research in Zambia, Lusaka, Zambia
  • Asociacion Civil Impacta Salud y Educacion, Lima, Peru
  • BJ Medical College-Johns Hopkins Clinical Trials Unit, Pune, India
  • Evandro Chagas National Institute of Infectious Diseases/Fiocruz, Rio de Janeiro, Brazil
  • Durban International CRS, Durban University of Technology, Durban, South Africa
  • YRGCARE Medical Centre, VHS, Chennai, India
  • HJF-DAIDS, a Division of The Henry M Jackson Foundation for the Advancement of Military Medicine, Contractor to National Institute of Allergy and Infectious Diseases, Bethesda, MD 
  • Social and Scientific Systems, Silver Spring, MD 
  • Frontier Science, Buffalo, NY 
  • Stanford University, Palo Alto, CA 
  • Johns Hopkins University School of Medicine, Baltimore, MD