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Background We compared two combinations of nucleosides with zidovudine alone in patients with advanced human immunodeficiency virus (HIV) infection.
Methods A total of 1102 patients with the acquired immunodeficiency syndrome or fewer than 200 CD4 cells per cubic millimeter were randomly assigned to receive zidovudine alone or zidovudine combined with either didanosine or zalcitabine. Disease progression, survival, toxic effects, and the CD4 cell response were assessed.
Results After a median follow-up of 35 months, disease progression or death occurred in 62 percent of the 363 patients assigned to zidovudine plus didanosine, 63 percent of the 367 assigned to zidovudine plus zalcitabine, and 66 percent of the 372 assigned to zidovudine alone (P = 0.24). As compared with zidovudine therapy, treatment with zidovudine plus didanosine was associated with a relative risk of disease progression or death of 0.86 (95 percent confidence interval, 0.71 to 1.03), and treatment with zidovudine plus zalcitabine was associated with a relative risk of 0.92 (95 percent confidence interval, 0.76 to 1.10). Survival was similar in the three groups. In a subgroup analysis, combination therapy delayed disease progression or death in patients who had previously received zidovudine for 12 months or less. Therapy with zidovudine plus didanosine resulted in more gastrointestinal adverse effects, and treatment with zidovudine plus zalcitabine, more neuropathy. The mean increases in CD4 cell counts at two months were higher with combination therapy than with zidovudine alone.
Conclusions In patients with advanced HIV infection, combination therapy with zidovudine and either didanosine or zalcitabine is not superior to zidovudine therapy alone. However, these combinations may be more effective than zidovudine monotherapy in patients with little or no previous zidovudine treatment.
Source Information
From St. John Hospital, Detroit (L.D.S.); the Delaware Community Program for Clinical Research on AIDS, Wilmington (D.L.W.); the Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis (G.C., J.S.H.); the Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Md. (C.P.); Albany Medical College, Albany, N.Y. (D.S.S.); Henry Ford Hospital, Detroit (N.M.); the Denver Community Program for Clinical Research on AIDS, Denver (R.R.); the Research and Education Group, Portland, Oreg. (M.O.L.); Wayne State University–Detroit Medical Center, Detroit (L.C.); the AIDS Research Consortium of Atlanta, Atlanta (M.T.); and the Community Consortium of San Francisco, San Francisco (D.A.). Presented in part at the Terry Beirn Community Programs for Clinical Research on AIDS Group Meeting, Washington, D.C., January 18, 1996; the Third Conference on Retroviruses and Opportunistic Infections, Washington, D.C., January 28–February 1, 1996; and the 11th International Conference on AIDS, Vancouver, B.C., July 7–12, 1996.
Address reprint requests to Dr. Lawrence Deyton at the National Institutes of Health, 6003 Executive Blvd., Bethesda, MD 20892.
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