Effects of zidovudine therapy in minority and other subpopulations with early HIV infection

Abstract

OBJECTIVE--The purpose of this study was to determine whether the beneficial effects of zidovudine seen overall in two recently completed placebo-controlled clinical trials are also apparent in blacks, Hispanics, women, and intravenous drug users. DESIGN--Two double-blind placebo-controlled randomized clinical trials, protocols 016 and 019, conducted by the AIDS Clinical Trials Group. SETTING--University-based referral centers. PARTICIPANTS--Two thousand forty-eight persons with asymptomatic or mildly symptomatic human immunodeficiency virus infection were analyzed. Of these, 155 were black, 190 were Hispanic, 144 were women, and 221 were intravenous drug users. All randomized subjects were included in the analysis. INTERVENTION--Participants in the AIDS Clinical Trials Group protocol 016 were assigned to receive a placebo or a 1200-mg daily dose of zidovudine. Participants in the AIDS Clinical Trials Group protocol 019 were assigned to receive a placebo, a 500-mg daily dose of zidovudine, or a 1500-mg daily dose of zidovudine. MAIN OUTCOME MEASURE--Progression to AIDS. RESULTS--The rates of progression to AIDS in subjects receiving zidovudine were significantly lower than those in subjects receiving a placebo among blacks (P = .03), whites (relative risk [RR] = 2.3, 95% confidence interval [CI] = 1.5 to 3.6, P less than .0001), Hispanics (RR = 4.4, CI = 1.2 to 16.8, P = .02), non-Hispanics (RR = 2.3, CI = 1.5 to 3.6, P = .0002), men (RR = 2.5, CI = 1.6 to 3.8, P less than .0001), and non-intravenous drug users (RR = 2.5, CI = 1.6 to 4.0, P less than .0001). The rates of disease progression for subjects receiving zidovudine were not statistically different from those receiving placebo for women (RR = 3.3, CI = 0.3 to 36.3, P = .31) or for intravenous drug users (RR = 2.0, CI = 0.7 to 6.2, P = .21); however, in both instances the estimated RRs were similar to those for men and non-intravenous drug users.

Conclusions: -Although the two studies used for this analysis were not specifically designed to assess the effects of zidovudine in each separate subpopulation, the data suggest that the beneficial effects of zidovudine reported for the entire study population also apply to the subpopulations of blacks, Hispanics, women, and intravenous drug users.