TY - JOUR AU1 - Kinloch-de Loës, Sabine AU2 - Hirschel, Bernard J. AU3 - Hoen, Bruno AU4 - Cooper, David A. AU5 - Tindall, Brett AU6 - Carr, Andrew AU7 - Saurat, Jean-Hilaire AU8 - Clumeck, Nathan AU9 - Lazzarin, Adriano AU1 - Mathiesen, Lars AU1 - Raffi, François AU1 - Antunes, Francisco AU1 - von Overbeck, Jan AU1 - Lüthy, Ruedi AU1 - Glauser, Michel AU1 - Hawkins, David AU1 - Baumberger, Christophe AU1 - Yerly, Sabine AU1 - Perneger, Thomas V. AU2 - Perrin, Luc AB - BackgroundIt is possible that antiretroviral treatment given early during primary infection with the human immunodeficiency virus (HIV) may reduce acute symptoms, help preserve immune function, and improve the long-term prognosis.MethodsTo assess the effect of early antiviral treatment, we conducted a multicenter, double-blind, placebo-controlled trial in which 77 patients with primary HIV infection were randomly assigned to receive either zidovudine (250 mg twice daily; n = 39) or placebo (n = 38) for six months.ResultsThe mean time from the onset of symptoms until enrollment in the study was 25.1 days. Among the 43 patients who were still symptomatic at the time of enrollment, there was no appreciable difference in the mean (±SE) duration of the retroviral syndrome between the zidovudine group (15.0±4.1 days) and the placebo group (15.8±3.6 days). During a mean follow-up period of 15 months, minor opportunistic infections developed in eight patients: oral candidiasis in four, herpes zoster in two, and oral hairy leukoplakia in two. Disease progression was significantly less frequent in the zidovudine group (one opportunistic infection) than in the placebo group (seven opportunistic infections; P = 0.009 by the log-rank test). After adjustment for the base-line CD4 cell count, the patients treated with zidovudine had an average gain of 8.9 CD4 cells per cubic millimeter per month (95 percent confidence interval, -1.4 to 19.1) during the first six months of the study, whereas those receiving placebo had an average loss of 12.0 CD4 cells per cubic millimeter per month (95 percent confidence interval, 5.2 to 18.7), for a between-group difference of 20.9 CD4 cells per cubic millimeter per month (95 percent confidence interval, 8.5 to 33.2; P = 0.001).ConclusionsAntiretroviral therapy administered during primary HIV infection may improve the subsequent clinical course and increase the CD4 cell count. TI - A Controlled Trial of Zidovudine in Primary Human Immunodeficiency Virus Infection JF - The New England Journal of Medicine DO - 10.1056/NEJM199508173330702 DA - 1995-08-17 UR - https://www.deepdyve.com/lp/the-new-england-journal-of-medicine/a-controlled-trial-of-zidovudine-in-primary-human-immunodeficiency-eHUi1UFmr0 SP - 408 EP - 413 VL - 333 IS - 7 DP - DeepDyve ER -