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

COMBINATION 3TC (LAMIVUDINE) ZDV (ZIDOVUDINE) VS ZDV MONOTHERAPY IN ZDV PRE-TREATED HIV-1 POSITIVE PATIENTS WITH CD4 OF 100-400 CELLS/MM3

S. Staszewski - The European Lamivudine HIV Working Group
Klinikum der Johann Wolfgang, Goethe-Universitat, Frankfurt, Germany

Int Cong Drug Therapy HIV 1994 Nov 18-22;2:Abstract No. 7.6
AIDS 1994, Vol. 8 (Suppl. 4);S7

The three-arm, double-blind controlled trial compared the safety and efficacy of 24 weeks treatment with three regimens: (i) 3TC (300mg bid) + ZDV (200mg tid), (ii) 3TC (l50mg bid) + ZDV (200mg tid) and (iii) ZDV monotherapy (200mg tid). Inclusion criteria were CD4 counts of 100-400 cells/mm³ and at least 6 months of prior ZDV treatment 223 patienls were randomised and assessed for treatment efficacy using surrogate marker measurements, clinical adverse events, laboratory toxicities and symptoms of HIV-1 disease at baseline, week 2, week 4 and then every four weeks. After 24 weeks, all patients were offered open-label treatment with 3TC and ZDV.

Blinded data shows that the median baseline CD4 count was 251 and the median duration of ZDV pre-treatment was 22 months. There have been 14 withdrawals to date and no significant increase in the incidence of Grade III/IV clinical or laboratory toxicity compared to historical controls.

Final analysis of 24 week unblinded data on CD4 p24, ICD p24, cellular viraemia, β 2-microglobulin and neopterin and a full safety analysis will be presented.

Presenting author: S. Staszewski

1994-11-18
7.6

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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