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CD4(+) lymphocyte count and human immunodeficiency virus (HIV) type 1 RNA level are useful for determining when to initiate antiretroviral therapy but are not used widely in developing countries due to the high cost. Heat-denatured protein 24 (p24) antigen is an inexpensive assay that predicts disease progression among persons with advanced disease but has not been assessed among persons with early-stage disease. Plasma levels of heat-denatured p24 antigen were quantified in baseline study-visit specimens obtained from injection drug users enrolled in a longitudinal cohort study of HIV-1 infection. Of the 494 study participants (median initial CD4(+) lymphocyte count, 518 lymphocytes/mm(3)), 90 (18%) progressed to acquired immunodeficiency syndrome within 5 years. p24 antigen level correlated with both CD4(+) lymphocyte count (r=-0.34; P&lt;.0001) and HIV-1 RNA level (r=0.55; P&lt;.0001). p24 antigen level &gt;5 pg/mL predicted disease progression, comparable with that of cutoff CD4(+) lymphocyte count &lt;350 lymphocytes/mm(3) and HIV-1 RNA level &gt;30,000 copies/mL. Heat-denatured p24 antigen level predicted subsequent clinical disease progression in early-stage HIV-1 infection and correlated with both CD4(+) lymphocyte count and HIV-1 RNA level.

Heat‐Denatured Human Immunodeficiency Virus Type 1 Protein 24 Antigen: Prognostic Value in Adults with Early‐Stage Disease