Third International Congress Drug Therapy in HIV Infection 3-7 November 1996 Glasgow, UK

CONTROLLED RANDOMIZED TRIAL OF GANCICLOVIR (GCV) IN COMPARISON TO HALF DOSE COMBINATION THERAPY WITH GCV AND FOSCARNET (PFA) IN CMV RETINITIS

A. Stoehr*, B. Salzberger#, V. Knospe+, A. Plettenberg*, K. U. Bartz-Schmitz#, H. Albrecht+, H. J. Stellbrink+, S. Thomalla#, M. Schrappe
*AK St. Georg Hamburg, #Univ. Klinik Köln, +UKE Hamburg, FRG

Int Cong Drug Therapy HIV 1996 Nov 3-7;3:Abstract No. OP3.4
AIDS 1996, Vol. 10 (Suppl. 2);S12

OBJECTIVE: To determine the antiviral activity of Ganciclovir and Foscarnet combined in a prospective randomized clinical trial.

PATIENTS AND METHODS: 44 HIV-infected patients (pat.) with their first (n=38) or second episode (n=7) of CMV retinitis, (male 42, female 2; median age 37 year; median CD4-lymphocytes 10c/mcl (0-147); CDC C3: 42 pat., CDC B3 3 pat.) -one pat. treated twice-, were randomized in an open study to receive either 5mg/kg GCV iv bid or 2,5mg/kg GCV plus 45mg/kg PFA bid (Combi.). Retinitis was controlled weekly, and the photographs were evaluated "blinded" by external reviewers. Predefined criteria were used to assess efficacy. Blood cell counts, serum elektrolytes, creatine and BUN were measured twice weekly.

RESULTS: GCV group: 1 of 23 pat. were not evaluable because of non compliance; 17 (74%) pat. were treated successfully; 5 (22%) pat. had treatment failure. Median duration of induction was 20 days. Combi. group: 21 pat with 22 episodes were included. 18 (82%) episodes were treated successfully, 2 (9%) pat. had treatment failure. The difference is statistical not significant. One pat. stopped treatment because of back pain, another changed to monotherapy because of mild nephrotoxicity. Median duration of treatment was 21 days. There was no statistically significant difference in hematological toxicity although a greater use of GCSF (25 vs 11 days) in the GCV group was noted. No severe renal toxicity (creatinine > 2mg/dl) was seen. 2 penile ulcers were observed.

CONCLUSIONS: This randomized controlled trial is the first study showing the efficacy of half dose combination therapy of GCV and PFA versus standard therapy with GCV in treatment of CMV retinitis in HIV infected patients. Renal toxicity was not observed with this combination.

Presenting author: A. Stoehr

1996-11-03
OP3.4

Originally published in AIDS Volume 10, Supplement 2 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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