Virologic and immunologic benefits of initial combination therapy with zidovudine and zalcitabine or didanosine compared with zidovudine monotherapy. Wellcome Resistance Study Collaborative Group

J Infect Dis. 1996 Jun;173(6):1354-66. doi: 10.1093/infdis/173.6.1354.

Abstract

A randomized controlled study was done to determine whether initial combination therapy with zidovudine and zalcitabine or zidovudine and didanosine would delay the emergence of zidovudine-resistant virus. Human immunodeficiency virus (HIV)-1-infected patients with <300 CD4 cells/mm3 and <4 weeks of prior zidovudine therapy were randomized to zidovudine, zidovudine plus zalcitabine, or zidovudine plus didanosine. Combination therapy did not delay the emergence of zidovudine-resistant virus isolates. However, combination therapy resulted in a significant increase in CD4 cells through 72 weeks compared with zidovudine monotherapy and a greater and more sustained decline in serum HIV-1 RNA. Although this trial was not designed as a clinical end-point study, patients assigned to zidovudine plus didanosine combination therapy experienced a significant delay in time to first AIDS-defining event or death compared with those assigned to zidovudine monotherapy.

Publication types

  • Clinical Trial
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Antiviral Agents / adverse effects
  • Antiviral Agents / pharmacology
  • Antiviral Agents / therapeutic use*
  • CD4 Lymphocyte Count
  • Didanosine / adverse effects
  • Didanosine / therapeutic use*
  • Disease Progression
  • Drug Resistance, Microbial
  • Drug Therapy, Combination
  • Female
  • HIV Infections / drug therapy*
  • HIV Infections / mortality
  • HIV Infections / virology
  • HIV Seropositivity / drug therapy
  • HIV-1 / drug effects*
  • Humans
  • Male
  • Middle Aged
  • Phenotype
  • RNA, Viral / blood
  • Zalcitabine / adverse effects
  • Zalcitabine / therapeutic use*
  • Zidovudine / adverse effects
  • Zidovudine / pharmacology
  • Zidovudine / therapeutic use*

Substances

  • Antiviral Agents
  • RNA, Viral
  • Zidovudine
  • Zalcitabine
  • Didanosine