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Volume 335:1081-1090 October 10, 1996 Number 15 Next

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ABSTRACT

Background This double-blind study evaluated treatment with either a single nucleoside or two nucleosides in adults infected with human immunodeficiency virus type 1 (HIV-1) whose CD4 cell counts were from 200 to 500 per cubic millimeter.

Methods We randomly assigned 2467 HIV-1–infected patients (43 percent without prior antiretroviral treatment) to one of four daily regimens: 600 mg of zidovudine; 600 mg of zidovudine plus 400 mg of didanosine; 600 mg of zidovudine plus 2.25 mg of zalcitabine; or 400 mg of didanosine. The primary end point was a >50 percent decline in the CD4 cell count, development of the acquired immunodeficiency syndrome (AIDS), or death.

Results Progression to the primary end point was more frequent with zidovudine alone (32 percent) than with zidovudine plus didanosine (18 percent; relative hazard ratio, 0.50; P<0.001), zidovudine plus zalcitabine (20 percent; relative hazard ratio, 0.54; P<0.001), or didanosine alone (22 percent; relative hazard ratio, 0.61; P<0.001). The relative hazard ratios for progression to an AIDS-defining event or death were 0.64 (P = 0.005) for zidovudine plus didanosine, as compared with zidovudine alone, 0.77 (P = 0.085) for zidovudine plus zalcitabine, and 0.69 (P = 0.019) for didanosine alone. The relative hazard ratios for death were 0.55 (P = 0.008), 0.71 (P = 0.10), and 0.51 (P = 0.003), respectively. For zidovudine plus zalcitabine, the benefits were limited to those without previous treatment.

Conclusions Treatment with zidovudine plus didanosine, zidovudine plus zalcitabine, or didanosine alone slows the progression of HIV disease and is superior to treatment with zidovudine alone. Antiretroviral therapy can improve survival in patients with 200 to 500 CD4 cells per cubic millimeter.

Source Information

From Harvard Medical School, Boston (S.M.H., M.S.H.); Stanford University, Stanford, Calif. (D.A.K., T.C.M.); Harvard School of Public Health, Boston (M.D.H., H.G.); the University of Colorado, Denver (R.T.S.); the University of California, San Diego (R.H.H.); the University of Minnesota, Minneapolis (W.K.H.); Case Western Reserve University, Cleveland (M.M.L.); Northwestern University, Chicago (J.P.P.); and the Division of AIDS of the National Institute of Allergy and Infectious Diseases, Bethesda, Md. (M.N.). The following were additional authors: Terrence F. Blaschke, M.D. (Stanford University), David Simpson, M.D. (Mt. Sinai Medical Center), Colin McLaren, M.D. (Bristol-Myers Squibb), James Rooney, M.D. (Glaxo–Wellcome), and Miklos Salgo, M.D., Ph.D. (Hoffmann–LaRoche).

Address reprint requests to Dr. Hammer at the Division of Infectious Diseases, New England Deaconess Hospital, One Deaconess Rd., Kennedy-6, Boston, MA 02215.

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Extract | Full Text  
N Engl J Med 1997; 336:958-961, Mar 27, 1997. Correspondence

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