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

A RANDOMISED STUDY OF TWO COTRIMOXAZOLE (CTX) DOSES IN PRIMARY PROPHYLAXIS AGAINST PCP AND CEREBRAL TOXOPLASMOSIS

M.C. Payen, S. De Wit, J.P. Van Vooren, C.M. Farber, J.C. Legrand, J. Demonty, B. Sommereijns, N. Van Cutsem, N. Clumeck and the COPRIM Trial Group, Belgium


Int Cong Drug Therapy HIV 1996 Nov 3-7;3:Abstract No. OP3.1
AIDS 1996, Vol. 10 (Suppl. 2);S11

OBJECTIVES: To compare the efficacy and tolerability of 2 doses of Cotrimoxazole (CTX) as primary prophylaxis against PCP and cerebral toxoplasmosis in HIV patients.

STUDY DESIGN: During a 27 months period, HIV patients with CD4 call count below 200/mm³ or 14 % were randomised to receive CTX (double strengh tablets) either one tablet daily (group A) or 3 tablets weekly (group B). Study end-points were PCP, toxoplasmosis and death.

RESULTS: 107 patients were randomised (group A 54 - group B: 53).There were no statistically significant differences in the demographic, clinical characteristics and mean CD4 cell count (group A: 125/µl - group B: 123/µl) at baseline.

The incidence of side effects leading to stop the study drug (mainly cutaneous rash with fever) was similar in the 2 groups (group A: 28 % - group B: 24 % - p=0.4). The haematological tolerance was the same.

CONCLUSION: In the intent to treat analysis, efficacy and tolerability of the 2 regimens are not statistically different. However, in the on-treatment analysis, the efficacy of the high dose appears to be better. Some larger studies are ongoing to confirm these results. In view of these preliminary results one could recommend to use the high dose (1 DS tablet daily) which can be reduced in case of intolerance. An escalating dose regimen could be another alternative.

Presenting author: M.C. Payen

1996-11-03
OP3.1

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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