Zidovudine side effects as reported by black, Hispanic, and white/non-Hispanic patients with early HIV disease: combined analysis of two multicenter placebo-controlled trials.

The objective of this study was to determine whether HIV patients' subjective tolerance of zidovudine differs by racial or ethnic grouping by conducting a post hoc analysis of reported symptoms in two multicenter, placebo-controlled trials of zidovudine monotherapy for early HIV disease. Ratios of rates of developing new or worsening symptoms as reported by patients assigned to active drug or placebo were compared in groups of white/non-Hispanic, black, or Hispanic origin. Patients were included in the study if they had asymptomatic HIV disease and entry absolute CD4 lymphocyte counts below 500 cells/microL and were enrolled in National Institute of Allergy and Infectious Diseases AIDS Clinical Trials Group (ACTG) protocol 019 or had mild symptoms of HIV disease, were enrolled in ACTG protocol 016, met protocol eligibility criteria for the respective trial, and were categorized at entry as white/non-Hispanic (N = 1801), black (N = 195), or Hispanic (n = 214). The primary outcome measure was development of a new or worsening symptom of any severity. Among patients treated with zidovudine compared with placebo, the estimated risk for developing a new or worsening symptom was not significantly greater for blacks or Hispanics than for white/non-Hispanics for any of the most frequently reported symptoms (p > 0.05 after adjustment for the multiple comparisons performed). Our analysis of 195 black and 214 Hispanic patients did not reveal a significantly increased risk of subjective zidovudine intolerance compared with white/non-Hispanic subjects. If there is an increased risk of such intolerance in minority groups compared with white/non-Hispanics, it is not likely to be clinically important.

RCT Entities:   Population Interventions Outcomes