A double-'blind' placebo-controlled study of nitazoxanide in the treatmentof cryptosporidial diarrhoea in AIDS patients in Mexico

Sixty-six patients with human immunodeficiency virus infection and diarrhoe a caused by Cryptosporidium parvum were enrolled in a double-'blind' placeb o-controlled study to evaluate the safety and efficacy of nitazoxanide in t he treatment of cryptosporidiosis related to the acquired immune deficiency syndrome. Patients were randomly assigned to one of 3 treatment groups and received either 500 mg twice daily of nitazoxanide, 1000 mg twice daily of nitazoxanide, or placebo orally for 14 d; the patients on nitazoxanide the n crossed over to placebo while the placebo patients crossed over to nitazo xanide therapy at either the high or low dose depending on their randomizat ion. Three post-treatment faecal examinations were conducted on days 15, 22 and 29 following initiation of treatment; patients were considered 'cured' if none revealed any C. parvum oocysts. Both doses of nitazoxanide produce d parasitological cure rates superior to the placebo responses (12/19 [63%, P=0.016] for patients receiving 1 g/d and 10/15 [67%, P=0.013] for those r eceiving 2 g/d). Parasitological cure was correlated with the complete reso lution of the diarrhoeal syndrome in 19 of the 22 treated patients who were considered parasitologically cured (86%). Both doses of nitazoxanide were well tolerated by the patients.