Second International Congress Drug Therapy in HIV Infection 18-22 November 1994 Glasgow, UK

RESULTS OF A RANDOMIZED MULTICENTER STUDY (ISS 902) FOR THE COMPARATIVE EVALUATION OF AZT AND DDI IN PREVIOUSLY UNTREATED PATIENTS WITH MILDLY SYMPTOMATIC HIV DISEASE.

Vella Stefano, Floridia M., Seeber A., Tomino C., Sebastiani G., Fragola V., Weimer L.E., Ricciardulli D
(Laboratorio di Virologia, Istituto Superiore di Sanitá, Rome), and the Italian AZT/DDI Evaluation Group.

Int Cong Drug Therapy HIV 1994 Nov 18-22;2:Abstract No. 7.3
AIDS 1994, Vol. 8 (Suppl. 4);S6

OBJECTIVES: To compare the effect on clinical progression and the toxicity patterns of DDI and AZT as first-line treatments in untreated ARC patients.

METHODS: Population: Patients with at least one symptom and CD4+ < 500 mm³ with no previous antiretroviral treatment. Major end-point for efficacy was HIV disease progression (development of AIDS). CD4 response did not represent a primary efficacy end-point. Major end-points for toxicity were adverse events leading to discontinuation of treatment.

RESULTS: Sample size: more than 500 patients were enrolled, with a relatively high proportion of women (28 %). Events: over 100 AIDS defining events were recorded during the study period (the trial started on September 1990). Mean follow up: about two years. Efficacy: An intention to treat approach was used to describe progression to AIDS and survival in a Kaplan-Meyer analysis. Subgroup analysis was performed according to baseline CD4 levels and clinical status. Toxicity: AZT and DDI showed similar toxicity event rates, but distinct toxicity patterns: main adverse events for AZT were due to haematological toxicity, while DDI use was associated with a higher rate of pancreatic involvement, mostly represented by asymptomatic hyperamilasemia, with low clinical pancreatitis rate.

Presenting author: Vella Stefano

1994-11-18
7.3

Originally published in AIDS Volume 8, Supplement 4 and hosted with permission of the publisher Lippincott Williams & Wilkins, 250 Waterloo Road, London, SE1 8RD, UK. Tel: +44 (0)20 7981 0700 Fax: +44 (0) 7981 0701

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