HIV/AIDS & Cryptosporidiosis: Nitazoxanide safe and useful for treatment of AIDS-related cryptosporidiosis

AIDSWEEKLY Plus; Monday, November 6, 2006
Staff Medical Writers

According to a recently published study from the United States, "Cryptosporidiosis in patients with acquired immune deficiency syndrome is a serious, life-threatening disease.

"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."

"Patients at least 3 years of age with acquired immune deficiency syndrome, diarrhea (greater than or equal to4 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. Three hundred and sixty-five patients were enrolled at 165 study centers throughout the USA. The duration of treatment ranged from 1 to 1528 days (median 62 days)," wrote J.F. Rossignol and colleagues at the Romark Institute for Medical Research in Tampa.

"Among the 357 patients included in the intent-to-treat analysis," investigators reported, "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."

The authors concluded, "Nitazoxanide can be considered useful therapy for treatment of with acquired immune deficiency syndrome-related cryptosporidiosis."

Rossignol and colleagues published their study in Alimentary Pharmacology & Therapeutics (Nitazoxanide in the treatment of acquired immune deficiency syndrome-related cryptosporidiosis: results of the United States compassionate use program in 365 patients. Aliment Pharmacol Ther. 2006 Sep 1;24(5):887-94).

For additional information, contact J.F. Rossignol, Romark Institute Med Research, Dept. of Clinic Research, 3000 Bayport Dr., Suite 200, Tampa, FL 33607, USA.

The publisher of the journal Alimentary Pharmacology & Therapeutics can be contacted at: Blackwell Publishing, 9600 Garsington Rd., Oxford OX4 2DQ, Oxon, England.

Keywords: Tampa, Florida, United States, Cryptosporidiosis, Nitazoxanide, HIV/AIDS, Diarrhea.

This article was prepared by AIDS Weekly editors from staff and other reports.

Reference

Rossignol JF., “Nitazoxanide in the treatment of acquired immune deficiency syndrome-related cryptosporidiosis: results of the United States compassionate use program in 365 patients”, Aliment Pharmacol Ther. 2006 Sep 1;24(5):887-94.

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