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Nitazoxanide in the treatment of acquired immune deficiency syndrome-related cryptosporidiosis: results of the United States compassionate use program in 365 patients Rossignol JFAliment Pharmacol Ther 2006[Sep]; 24 (5): 887-94BACKGROUND: Cryptosporidiosis in patients with acquired immune deficiency syndrome is a serious, life-threatening disease. AIM: A large compassionate use clinical trial was conducted in the USA to make nitazoxanide available to patients with acquired immune deficiency syndrome-related cryptosporidiosis and to collect data related to safety and effectiveness of the drug in this population. METHODS: Patients at least 3 years of age with acquired immune deficiency syndrome, diarrhoea (> or =4 stools/day for >2 weeks) and Cryptosporidium-positive stools received 500-1500 mg of nitazoxanide twice daily. Patients were evaluated at weeks 1, 2, 4 and monthly thereafter for drug safety and effectiveness including the stool examinations, review of symptoms and patient diaries. Data analysis for clinical and parasitological response was intention-to-treat. RESULTS: Three hundred and sixty-five patients were enrolled at 165 study centres throughout the USA. The duration of treatment ranged from 1 to 1,528 days (median 62 days). Among the 357 patients included in the intent-to-treat analysis, 209 (59%) achieved a sustained clinical response while on treatment. Clinical responses were closely associated with Cryptosporidium-negative stools (P < 0.0001). No safety issues were identified at doses up to 3000 mg/day or for long durations of treatment. CONCLUSIONS: Nitazoxanide can be considered useful therapy for treatment of with acquired immune deficiency syndrome-related cryptosporidiosis.|AIDS-Related Opportunistic Infections/complications/*drug therapy/epidemiology[MESH]|Adolescent[MESH]|Adult[MESH]|Age Distribution[MESH]|Aged[MESH]|Antiparasitic Agents/adverse effects/*therapeutic use[MESH]|CD4 Lymphocyte Count[MESH]|Child[MESH]|Child, Preschool[MESH]|Cryptosporidiosis/complications/*drug therapy[MESH]|Diarrhea/complications/drug therapy/epidemiology[MESH]|Feces/parasitology[MESH]|Female[MESH]|Humans[MESH]|Male[MESH]|Middle Aged[MESH]|Nitro Compounds[MESH]|Sex Distribution[MESH]|Thiazoles/adverse effects/*therapeutic use[MESH]|Time Factors[MESH]|Treatment Outcome[MESH]|United States/epidemiology[MESH] |
