ZIDOVUDINE SIDE-EFFECTS AS REPORTED BY BLACK, HISPANIC, AND WHITE NON-HISPANIC PATIENTS WITH EARLY HIV DISEASE - COMBINED ANALYSIS OF 2 MULTICENTER PLACEBO-CONTROLLED TRIALS

The objective of this study was to determine whether HIV patients' sub jective tolerance of zidovudine differs by racial or ethnic grouping b y conducting a post hoc analysis of reported symptoms in two multicent er, placebo-controlled trials of zidovudine monotherapy for early HIV disease. Ratios of rates of developing new or worsening symptoms as re ported by patients assigned to active drug or placebo were compared in groups of white/non-Hispanic, black, or Hispanic origin. Patients wer e included in the study if they had asymptomatic HIV disease and entry absolute CD4 lymphocyte counts below 500 cells/mu L and were enrolled in National Institute of Allergy and Infectious Diseases AIDS Clinica l Trials Group (ACTG) protocol 019 or had mild symptoms of HIV disease , were enrolled in ACTG protocol 016, met protocol eligibility criteri a for the respective trial, and were categorized at entry as white/non -Hispanic (N = 1801), black (N = 195), or Hispanic (n = 214). The prim ary outcome measure was development of a new or worsening symptom of a ny severity. Among patients treated with zidovudine compared with plac ebo, the estimated risk for developing a new or worsening symptom was not significantly greater for blacks or Hispanics than for white/non-H ispanics for any of the most frequently reported symptoms (p > 0.05 af ter adjustment for the multiple comparisons performed). Our analysis o f 195 black and 214 Hispanic patients did not reveal a significantly i ncreased risk of subjective zidovudine intolerance compared with white /non-Hispanic subjects. If there is an increased risk of such intolera nce in minority groups compared with white/non-Hispanics, it is not li kely to be clinically important.