Zidovudine alone or in combination with didanosine or zalcitabine in HIV-infected patients with the acquired immunodeficiency syndrome or fewer than 200 CD4 cells per cubic millimeter

Louis D. Saravolatz, Dean L. Winslow, Gary Collins, James S. Hodges, Carla Pettinelli, Daniel S. Stein, Norman Markowitz, Randall Reves, Mark O. Loveless, Lawrence Crane, Melanie Thompson, Donald Abrams, Lawrence Deyton

Research output: Contribution to journalArticle

153 Scopus citations

Abstract

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.

Original languageEnglish (US)
Pages (from-to)1099-1106
Number of pages8
JournalNew England Journal of Medicine
Volume335
Issue number15
DOIs
StatePublished - Oct 10 1996

Fingerprint Dive into the research topics of 'Zidovudine alone or in combination with didanosine or zalcitabine in HIV-infected patients with the acquired immunodeficiency syndrome or fewer than 200 CD4 cells per cubic millimeter'. Together they form a unique fingerprint.

  • Cite this

    Saravolatz, L. D., Winslow, D. L., Collins, G., Hodges, J. S., Pettinelli, C., Stein, D. S., Markowitz, N., Reves, R., Loveless, M. O., Crane, L., Thompson, M., Abrams, D., & Deyton, L. (1996). Zidovudine alone or in combination with didanosine or zalcitabine in HIV-infected patients with the acquired immunodeficiency syndrome or fewer than 200 CD4 cells per cubic millimeter. New England Journal of Medicine, 335(15), 1099-1106. https://doi.org/10.1056/NEJM199610103351503