Five-year follow-up of a phase I study of didanosine in patients with advanced human immunodeficiency virus infection

J Infect Dis. 1995 May;171(5):1180-9. doi: 10.1093/infdis/171.5.1180.

Abstract

Starting in 1988, 72 patients with advanced human immunodeficiency virus (HIV) infection were enrolled in a phase I study of didanosine at the National Cancer Institute. Beginning in 1992, patients with decreases in CD4 cell counts could switch to a combination of zidovudine and didanosine. The estimated median survival for all patients was 28 months (95% confidence interval, 23-46). However, for patients whose entry CD4 cell counts were 100-300/mm3, the estimated 4-year survival was 80%. Baseline CD4 and CD8 cell counts, hemoglobin, lymphocytes, sedimentation rates, diagnosis of AIDS, and fever were significant predictors of overall survival. Principal toxicities were pancreatitis and peripheral neuropathy; no new toxicities were seen with extended didanosine treatment that had not been observed in shorter-term studies. This 5-year follow-up shows that didanosine can be tolerated for > 4 years in some patients with advanced HIV infection and may have particular long-term utility in patients with moderately advanced immunosuppression.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase I

MeSH terms

  • Adult
  • CD4 Lymphocyte Count
  • Didanosine / administration & dosage
  • Didanosine / adverse effects
  • Didanosine / therapeutic use*
  • Disease Progression
  • Drug Therapy, Combination
  • Female
  • Follow-Up Studies
  • HIV Infections / drug therapy*
  • HIV Infections / immunology
  • HIV Infections / mortality*
  • Humans
  • Male
  • Middle Aged
  • Survival Rate
  • Zidovudine / therapeutic use

Substances

  • Zidovudine
  • Didanosine