Didanosine in the Treatment of AIDS and AIDS-Related Complex: A Critical Appraisal of the Dose and Frequency of Administration

• Published in: Clinical infectious diseases 1993-02, Vol.16 (Supplement-1), p.S52-S58
• Main Authors: Liebman, Howard A., Cooley, Timothy P.
• Format: Article
• Language: English
• Subjects: Acquired Immunodeficiency Syndrome - drug therapy; Acquired Immunodeficiency Syndrome - immunology; Administered dose; AIDS; AIDS related complex; AIDS-Related Complex - drug therapy; AIDS-Related Complex - immunology; Antigens; CD4-Positive T-Lymphocytes - drug effects; Didanosine - administration & dosage; Didanosine - adverse effects; Didanosine - therapeutic use; Dosage; Dose response relationship; Drug Administration Schedule; Experimentation; Female; Follow-Up Studies; HIV; Humans; Leukocyte Count - drug effects; Lymphocytes; Male; Medication administration; Survival Analysis
• ISSN: 1058-4838; 1537-6591
• DOI: 10.1093/clinids/16.Supplement_1.S52

In the summer of 1988, dose-finding phase 1 trials of the efficacy and safety of didanosine were begun by investigators at the National Cancer Institute (NCI), by the AIDS Clinical Trials Group (ACTG) at New York University School of Medicine and the University of Rochester School of Medicine, and by researchers at Boston City Hospital (BCH). The schedules of drug administration studied included once daily (BCH), twice daily (ACTG and NCI), and three times daily (NCI). The total daily dose studied ranged from 0.8 to 66 mg/(kg · d). Significant toxicities developed in more than half of the patients receiving doses of