During a 12 month open clinical trial, 14 patients (6 with AIDS, 2 with ARC and 6 with PGL) were continuously administered a daily 1200 mg dose of Zidovudine. Clinical course was correlated with a number of serological (HIV p24 antigen, p17 and p24 antibodies) and immunological (CD4 cell counts, serum neopterin and beta 2-microglobulin levels) parameters. All patients survived until the end of the trial: none developed major opportunistic infections, but 5 required an average of 7 blood transfusions each. Disappearance of p24 Ag was observed in 4 out of 7 patients, although with a subsequent reappearance in 3; moreover, changes of p24 Ag and HIV core Ab profiles were generally paralleled by neopterin and, to a lesser extent, by CD4/neopterin ratio variations. In the long run, significant differences between baseline and end-point results were shown by neopterin, but not by CD4 cell counts and beta 2-microglobulin levels. Efficacy of Zidovudine therapy seemed to be mainly related to clinical, but even more so, to immunological and serological status at baseline; in fact, severe clinical deterioration was observed in 2 patients who had an already low CD4/neopterin ratio from the beginning, coupled with a p24 Ag positivity and a negativity of both anti-p17 and -p24. Conversely, a stable clinical condition was observed in those patients in whom the reverse was true.
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