Comparative evaluation of AZT and DDI in previously untreated patients with early or advanced ARC: preliminary results of the Italian Randomized Multicenter Study ISS-902.

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Comparative evaluation of AZT and DDI in previously untreated patients with early or advanced ARC: preliminary results of the Italian Randomized Multicenter Study ISS-902.

Int Conf AIDS. 1992 Jul 19-24;8(1):Mo21 (abstract no. MoB 0080). Unique Identifier : AIDSLINE ICA8/92400036
Vella S; Floridia M; Tomino C; Dally LG; Sebastiani G; Fragola V; Chiesi A; Istituto Superiore di Sanita, Rome, Italy.

Abstract: OBJECTIVES: 1) To determine whether DDI therapy is as effective as AZT in delaying clinical progression to AIDS or advanced ARC among patients with previously untreated ARC (at least one symptom and CD4+ 500/mm3). 2) To evaluate the pattern of toxicity of DDI when administered in the early stages of ARC. METHODS: ISS-902 is an ongoing, multicenter, open, comparative study in which AZT-naive patients are randomly assigned to AZT or DDI (final target: 600 patients). The major end-point for efficacy is HIV disease progression (development of AIDS or advanced ARC, survival). Major end-points for toxicity are adverse events leading to discontinuation of treatment. RESULTS: The mean base-line CD4+ value at enrollment was 238/mm3. Preliminary results (cut-off date for the first interim analysis: Dec. 15th, 1991) obtained on 240 patients, who had mean follow up of approximately 200 days, showed no major difference in disease progression among the two groups. AZT and DDI showed distinct toxicity patterns: the main adverse events for AZT were related to haematological toxicity, while DDI results confirmed previous reports of pancreatic involvement. However, in this early-disease population, overall tolerance was good, and no life-threatening drug-related events were observed. CD4+ response to treatment appeared comparable for the two drugs, with a consistent advantage for DDI-treated patients, particularly among those patients initiating therapy with higher base-line values. CONCLUSIONS: DDI and AZT appear comparable in the effects on disease progression, although DDI produces a greater CD4+ response to treatment. The two drugs produce different, but non life-threatening toxicity.

Keywords: Acquired Immunodeficiency Syndrome/PREVENTION & CONTROL AIDS-Related Complex/*DRUG THERAPY Comparative Study Didanosine/ADVERSE EFFECTS/*THERAPEUTIC USE Hematologic Diseases/CHEMICALLY INDUCED Human Italy Pancreatic Diseases/CHEMICALLY INDUCED Zidovudine/ADVERSE EFFECTS/*THERAPEUTIC USE ABSTRACT
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M92C5311

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