Safety and tolerance of dideoxycytidine as a single agent. Results of early-phase studies in patients with acquired immunodeficiency syndrome (AIDS) or advanced AIDS-related complex. Study Group of the AIDS Clinical Trials Group of the National Institute of Allergy and Infectious Diseases

Am J Med. 1990 May 21;88(5B):11S-15S. doi: 10.1016/0002-9343(90)90415-a.

Abstract

Phase I and II clinical studies have been conducted to test the safety and potential activity of the reverse transcriptase inhibitor, dideoxycytidine (ddC), in treating human immunodeficiency virus-1-infected patients. Although ddC appears to be active in combating viral infection, as judged by its ability to decrease human immunodeficiency virus-1 p24 antigen titers and increase the number of CD4+ lymphocytes, it is also capable of causing severe peripheral neuropathy in a dose-dependent manner. The studies discussed here indicate that low-dose ddC treatment regimens substantially reduce the toxic side effects of this drug, and yet retain the ability to affect p24 antigen and CD4+ lymphocyte levels. These studies also define the window of therapeutic usefulness for ddC, and suggest that both safety and activity can be maintained during long-term, low-dose use of ddC.

Publication types

  • Review

MeSH terms

  • AIDS-Related Complex / drug therapy*
  • AIDS-Related Complex / immunology
  • Acquired Immunodeficiency Syndrome / drug therapy*
  • Acquired Immunodeficiency Syndrome / immunology
  • Drug Evaluation
  • Drug Tolerance
  • Gene Products, gag / blood
  • HIV Antigens / blood
  • HIV Core Protein p24
  • HIV-1 / immunology
  • Humans
  • Viral Core Proteins / blood
  • Zalcitabine / administration & dosage
  • Zalcitabine / adverse effects
  • Zalcitabine / pharmacology
  • Zalcitabine / therapeutic use*

Substances

  • Gene Products, gag
  • HIV Antigens
  • HIV Core Protein p24
  • Viral Core Proteins
  • Zalcitabine