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IRIS Study Opens in Kericho, Kenya

March 23, 2009
The U.S. Military HIV Research Program (MHRP) recently opened a new study in Kericho, Kenya studying the Immune Reconstitution Syndrome (IRIS) in HIV-1 infected patients.

The U.S. Military HIV Research Program (MHRP) recently opened a new study in Kericho, Kenya studying the Immune Reconstitution Syndrome (IRIS) in HIV-1 infected patients. This cohort observational study will evaluate the predictors, incidence, clinical presentation and immunopathogenesis of IRIS in human immunodeficiency virus (HIV-1) infected patients with CD4 Count <100 cells/µL who are initiating antiretroviral therapy.

The study is sponsored by the Infectious Diseases Research Program (IDCRP), and is a collaboration with the Kenya Medical Research Institute/Walter Reed Project HIV Program in Kericho and the Division of Clinical Research (DCR) of the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institute’s of Health (NIH).

IRIS is a clinical syndrome that has been described in HIV-infected patients after initiation of highly active anti-retroviral therapy (HAART), and is characterized by paradoxical acute worsening of an underlying opportunistic infection or AIDS-defining illness. There currently is no widely accepted syndromic definition, and the pathogenesis of the syndrome is unclear with no specific therapy. The syndrome is more common in patients with low CD4+ T cell counts (<50 cells/µl) and in those with certain underlying infections (e.g. mycobacterial or cryptococcal infection) and is typically observed when there is evidence of response to antiretroviral therapy (ART) and while patients are still at risk for other opportunistic infections (OIs) or AIDS defining illnesses (e.g. pneumocystis jirovecii pneumonia or cytomegalovirus [CMV] retinitis). The incidence of IRIS varies depending on the studied population, and is very frequent in developing countries creating significant diagnostic and therapeutic challenges with limited health resources.

The IRIS study will follow approximately 500 patients starting ART: approximately 100 at NIH in Bethesda, Md., and 400 in Kericho, Kenya. Enrollment is expected to take two years, and each volunteer will be followed for two years with an optional two-year extension for U.S. participants at NIH. HIV infected men and women who are >18 years, have not taken ART previously, and who have CD4+ T cell counts <100 cells/mm3 are eligible to participate. Study participants will receive ART according to the clinical standard of care.

The study is led overall by Dr. Irini Sereti in the Division of Intramural Research at the NIH, and Drs. Fred Sawe and Doug Shaffer in Kericho. Dr. Shaffer notes, “IRIS is an important study that will help us better understand the Immune Reconstitution Syndrome. Our NIH and Kericho team is excited to have the study open and to be working closely again with Dr. Obiero of the Kericho District Hospital. Not only we will learn a great deal about IRIS and HIV epidemiology in patients starting ART with advanced AIDS, but this study will also help improve clinical care in the larger Kericho region, which is always important in our research efforts.”