A Randomized Trial (ISS 902) of Didanosine versus Zidovudine in Previously Untreated Patients with Mildly Symptomatic Human Immunodeficiency Virus Infection

• Published in: The Journal of infectious diseases Vol. 175; no. 2; pp. 255 - 264
• Main Authors: Floridia, Marco, Vella, Stefano, Seeber, Angela C., Tomlno, Carlo, Fragola, Vincenzo, Weimer, Liliana E., Ricciardulli, Daniela, Milazzo, Francesco, Gritti, Francesco M., Mazzotta, Francesco, Ranieri, Sergio, Chiodo, Francesco, Moroni, Mauro, Cargnel, Antonietta, Bassetti, Dante, Giannini, Valerio, Crernoni, Luisella, Concia, Ercole, Sinicco, Alessandro, Carosi, Giampiero, Alberici, Francesco, Dianzani, Ferdinando
• Format: Journal Article
• Language: English
• Published: Chicago, IL The University of Chicago Press 01-02-1997; University of Chicago Press
• Subjects: Acquired Immunodeficiency Syndrome - diagnosis; Adult; AIDS; Anti-HIV Agents - adverse effects; Anti-HIV Agents - therapeutic use; Antivirals; Biological and medical sciences; Body Weight; CD4 Lymphocyte Count; Clinical trials; Didanosine - adverse effects; Didanosine - therapeutic use; Disease Progression; Dosage; Experimentation; Female; HIV; HIV Core Protein p24 - analysis; HIV Core Protein p24 - blood; HIV Infections - drug therapy; HIV Infections - mortality; human immunodeficiency virus; Humans; Immunodeficiencies; Immunodeficiencies. Immunoglobulinopathies; Immunopathology; Infections; Infectious diseases; Major Articles; Male; Medical sciences; Random allocation; Risk; T lymphocytes; Zidovudine - adverse effects; Zidovudine - therapeutic use; Human; Immunopathology; Purine nucleoside; Prognosis; Treatment efficiency; AIDS; Immune deficiency; Infection; Chemotherapy; Treatment; Viral disease; Dideoxynucleoside; Antiviral; Didanosine; Pyrimidine nucleoside; Zidovudine; Comparative study
• ISSN: 0022-1899; 1537-6613
• DOI: 10.1093/infdis/175.2.255

In this multicenter study (ISS 902), 554 previously untreated patients with <500 CD4 cells/mm3 and mildly symptomatic human immunodeficiency virus disease were randomized to receive zidovudine or didanosine (ddI). After a mean follow-up of 20 months, 80 patients (40 zidovudine, 40 ddI) had died and 146 had at least one AIDS-defining event (73 zidovudine, 73 ddI). Overall, no difference was found between treatments with respect to progression to AIDS or death. The analysis of relative risk (RR) of progression over time, however, showed an initially minor risk for zidovudine patients and an inversion in the zidovudine-ddI RR in the second and third years of follow-up. Didanosine showed a greater effect on CD4 cell count response. The two drugs confirmed the toxicity patterns already reported in other trials, with a low occurrence of pancreatitis (ddI 1.3%, zidovudine 0.4%). The overall results suggest that, in this population, zidovudine and ddI monotherapies have comparable long-term clinical efficacy and that more powerful regimens should be preferred.