A CONTROLLED TRIAL OF ZIDOVUDINE IN PRIMARY HUMAN-IMMUNODEFICIENCY-VIRUS INFECTION

Background. It is possible that antiretroviral treatment given early d uring primary infection with the human immunodeficiency virus (HIV) ma y reduce acute symptoms, help preserve immune function, and improve th e long-term prognosis. Methods. To assess the effect of early antivira l treatment, we conducted a multicenter, double-blind, placebo-control led trial in which 77 patients with primary HIV infection were randoml y assigned to receive either zidovudine (250 mg twice daily; n = 39) o r placebo (n = 38) for six months. Results. The mean time from the ons et of symptoms until enrollment in the study was 25.1 days. Among the 43 patients who were still symptomatic at the time of enrollment, ther e was no appreciable difference in the mean (+/-SE) duration of the re troviral syndrome between the zidovudine group (15.0+/-4.1 days) and t he 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 tester in two, and oral hairy leukop lakia in two. Disease progression was significantly less frequent in t he 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 trea ted with zidovudine had an average gain of 8.9 CD4 cells per cubic mil limeter per month (95 percent confidence interval, -1.4 to 19.1) durin g the first six months of the study, whereas those receiving placebo h ad an average loss of 12.0 CD4 cells per cubic millimeter per month (9 5 percent confidence interval, 5.2 to 18.7), for a between-group diffe rence of 20.9 CD4 cells per cubic millimeter per month (95 percent con fidence interval, 8.5 to 33.2; P = 0.001). Conclusions. Antiretroviral therapy administered during primary HIV infection may improve the sub sequent clinical course and increase the CD4 cell count.