CLINICAL SCIENCE: PDF OnlyBrief Report: A Study of the Immunology, Virology, and Safety of Prednisone in HIV-1-Infected Subjects with CD4 Cell Counts of 200 to 700 mm-3Wallis, Robert S.*††; Kalayjian, Robert†; Jacobson, Jeffrey M.‡; Fox, Lawrence§; Purdue, Lynette§; Shikuma, Cecilia M.∥; Arakaki, Richard∥; Snyder, Stuart¶; Coombs, Robert W.¶; Bosch, Ronald J.#; Spritzler, John#; Chernoff, Miriam#; Aga, Evgenia#; Myers, Laurie**; Schock, Barbara**; Lederman, Michael M.†† Author Information *The University of Medicine and Dentistry of New Jersey-New Jersey Medical School, Newark, New Jersey; †Metrohealth Medical Center, Cleveland, Ohio; ‡Mount Sinai Hospital, New York, New York; §Division of AIDS, NIAID, Bethesda, Maryland;∥University of Hawaii, Honolulu, Hawaii; ¶Department of Laboratory Medicine, University of Washington, Seattle, Washington; #Statistical Data and Analysis Center, Harvard School of Public Health, Boston, Massachusetts; **Frontier Science and Technology Research Foundation, Amherst, New York; ††Case Western Reserve University and University Hospitals of Cleveland, Cleveland, Ohio, U.S.A. Funding for this study was provided by NIH grants AI 25879, Al 38858, AI 38855, AI 26879, AI 36219, AI 27664, AI 30731, and MO1 RR00080. Address correspondence and reprint requests to Robert S. Wallis, Department of Medicine, UMDNJ-New Jersey Medical School, 185 South Orange Avenue, MSB I-503, Newark, NJ 07103, U.S.A; e-mail: [email protected] Manuscript received October 9, 2002; accepted December 17, 2002. JAIDS Journal of Acquired Immune Deficiency Syndromes 32(3):p 281-286, March 1, 2003. Free Abstract Summary: Adult Clinical Trials Group Study 349 examined the immunology, virology, and safety of 40 mg/d prednisone as an adjunct to antiretroviral therapy in 24 HIV-infected subjects with >200 CD4+ T cells/mm3 in a randomized placebocontrolled trial. After 8 weeks, median lymphocyte and CD4+ cell numbers increased >40% above baseline values (p = .08). No effect was observed on markers of cell activation or apoptosis, although the proportion of CD28+ CD8+ T cells increased (p = .006). Prednisone inhibited monocyte TNFα production without affecting T-cell responses to antigens or mitogens. Two subjects assigned to prednisone were subsequently found to have asymptomatic osteonecrosis of the hip. Many questions remain regarding the role of activation-induced sequestration and apoptosis as causes of progressive CD4+ T-cell loss in AIDS. The potential role of corticosteroids as tools to examine this question will be limited by concerns regarding their toxicity; however, further studies of other agents to limit cellular activation in AIDS are warranted. © 2003 Lippincott Williams & Wilkins, Inc.