Prospective Double-Blind Study of Zidovudine in Early Stage HIV Infection

摘要

Data were collected from Denver Health and Hospital civilian patients and FAMCmilitary patients with early HIV infection randomized to either Zidovudine or placebo at 800mg/day. Because of the salutary response to 12-1500mg of Zidovudine/day in patients treated above 200 CD4 helper cells/mcL in the early phase 2 studies, it was thought that the time to begin ZDV was when patients were between 2-500 helper cells and had at least one symptom (usually lymphadenopathy). Thus they were DOD class 2-5 persons. Although this study did not achieve the statistical significance for progression to severe ARC/ADS of the larger NIH studies or the VA/RAD1/WRAMc study, it provided a significant portion of the data for Zidovudine safety at 5-800mg/day and showed a very delimited trend toward retardation of DOD class progression which is important and preservation of health of the soldier, dependents and retired DOD health care beneficiaries. The study does further validate ZDV's effect on surrogate markers.