Virologic and Immunologic Benefits of Initial Combination Therapy with Zidovudine and Zalcitabine or Didanosine Compared with Zidovudine Monotherapy

Authors:
  • CRC Ramirez-Ronda
    C Ramirez-Ronda
  • JLJ M Lange
    J M Lange
  • DCD A Cooper
    D A Cooper
  • JLJ Lavelle
    J Lavelle
  • LLL Lefkowitz
    L Lefkowitz
  • MMM Moore
    M Moore
  • BLB A Larder
    B A Larder
  • MCM St Clair
    M St Clair
  • JMJ W Mulder
    J W Mulder
  • RMR McKinnis
    R McKinnis
  • KPK N Pennington
    K N Pennington
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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 zidovudineresistant virus. Human immunodeficiency virus (HIV)-1-infected patients with 3 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.