The relationship between 12-month CD4+ cell count response and clinical outcome (AIDS-defining event or death) in a subset of 228 patients with a human immunodeficiency virus load >400 copies/mL despite receiving combination antiretroviral therapy as part of a larger randomized trial was defined by use of Cox models. The 12-month CD4+ cell count responses were divided into 5 categories, ranging from decrease or no change (29% of patients) to a ≥100-cell/mm3 increase (27% of patients). There was a lower risk of clinical progression for each incremental increase in CD4 + cell count response. A 25-cell/mm3 increase in CD4 + cell count was associated with a 21% reduction in the risk of an AIDS-defining event or death (P<.0001).
Bibliographical noteFunding Information:
Received 24 March 2005; accepted 24 May 2005; electronically published 9 September 2005. Presented in part: 2nd IAS Conference on HIV Pathogenesis and Treatment, Paris, 15 July 2003 (oral abstract 144). Potential conflicts of interest: none reported. Financial support: US National Institutes of Health; Canadian HIV Trials Network; Agouron Canada; Canadian Institutes of Health Research (salary support to M.R.L.); Ontario HIV Treatment Network (salary support to S.L.W.). a Present affiliation: Department of Medicine, University of Toronto, Toronto, Ontario, Canada. Reprints or correspondence: Dr. James Neaton, University of Minnesota, 2221 University Ave. SE, Room 200, Minneapolis, MN 55414 (email@example.com).