Nitazoxanide in the treatment of acquired immune deficiency syndrome‐related cryptosporidiosis: results of the United States compassionate use program in 365 patients

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Abstract
Summary: Background: 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 (≥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 1528 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.