National Institute of Allergy and Infectious Diseases - November 20, 1991

Previously, the benefits of AZT for early intervention in the overall HIV-infected population were demonstrated in two NIAID-supported studies, A further examination of the data from these studies suggests that the benefits seen overall also apply to these four subpopulations. "This analytical study is especially important in light of the changing demographics of the AIDS epidemic." said Anthony S. Fauci, M.D., director of NIAID. "More and more, people of color, women, and injection drug users are being infected, and we need to know whether the treatments we prescribe are equally effective for all persons with HIV."

The research results are based on data from 2,048 patients enrolled in two multi-center AIDS clinical trials. These trials, known as ACTG 016 and 019, were carried out between 1987 and 1989 by the AIDS Clinical Trials Group, a network of clinical research center funded by NIAID.

The trials studied HIV-infected persons who were asymptomatic or showed mild symptoms of the disease at enrollment. Previous analyses of the data from ACTG 016 and 019 showed an overall benefit to those patients with CD4+ cell counts less than 500/mm3 who received AZT, compared to those who received a placebo. CD4+ cells are crucial immune system cells destroyed by HIV infection and their numbers are often used as a measure of the progression of the disease. Healthy, uninfected people usually have CD4+ counts in the range of 800- 1200/mm3.

The current analysis divided the participants in the two trials into subpopulations, based on how they described themselves. Of the 2,048 subjects included, 155 were black, 190 Hispanic, 144 women, and 221 past users of injection drugs. Current injection drug users were ineligible. The other participants were mostly homosexual white men.

Overall, the median age was 34. The risk of progression to AIDS or death during the study period for men in the overall group was 2.5 times greater for placebo subjects than for those taking AZT. For women, the relative risk was 3.3. For Hispanics, the relative risk was 4.4, for whites 2.3, and for injection drug users, 2.0. Among blacks, there were no disease progressions during the study period among 107 patients taking AZT, compared to three progressions among the 48 patients taking a placebo. "Although ACTG 016 and 019 were not specifically designed to assess the effects of AZT in these four subpopulations, these new findings clearly suggest that AZT can benefit a wide cross-section of American with HIV," said Daniel F. Hoth, M.D., director of NIAID's Division of AIDS.

The current analysis of the four subpopulations, as well as previous analyses of the overall patient group, is based on data through August 1989, when the studies were stopped. At that time, an interim analysis by an independent data and safety monitoring board found that there were significantly lower rates of HIV progression for patients receiving AZT than for those receiving a placebo. Since the time of the first patient enrollment in ACTG 016 and 019, the rates of newly acquired HIV infections in the United States have stabilized in homosexual men, but are on the rise in blacks, Hispanics, women, and injection drug users. Interest in the effect of AZT in these increasingly infected subpopulations grew after the initial results of a Veterans' Administration trial suggested that AZT therapy may be less effective in blacks and Hispanics than in whites.

The new findings suggest otherwise. "These results confirm what many persons with HIV and their doctors have seen in their own experience," said Dr. Fauci, "The usefulness of AZT is limited by its toxicity and the development of viral resistance, not by the gender, ethnicity, or thehistory of injection drug use of the patient taking it." Because current users of injection drugs were not included in the study, "Caution should be used in extrapolating these data to currently active injection drug users," the authors write. "However, we know of no reason to suspect that AZT is not beneficial to this population." Collaborators in the current study included Stephen Lagakos, Ph.D, and Lynette Lim, Ph.D, from Harvard University School of public Health; Margaret A. Fischl, M.D. University of Miami; Daniel S. Stein, M.D., University of California, San Francisco.

Published 1991 - National Institute of Allergy and Infectious Diseases . All material contained in this report is in the public domain and may be used and reprinted without special permission; citation to source, however, is appreciated.

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