Nitazoxanide in the treatment of acquired immune deficiency syndrome-related cryptosporidiosis: results of the United States compassionate use program in 365 patients.
BACKGROUND
Cryptosporidiosis in patients with acquired immune deficiency syndrome is a serious, life-threatening disease.


OBJECTIVE
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.
Rossignol
J-F
JF
Department of Clinical Research, The Romark Institute for Medical Research, Tampa, FL 33607, USA. jrossignol@romark.com
D017088:AIDS-Related Opportunistic Infections / Q000150:complications / Q000188:drug therapy* / Q000453:epidemiology; D000293:Adolescent; D000328:Adult; D017677:Age Distribution; D000368:Aged; D000977:Antiparasitic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D018791:CD4 Lymphocyte Count; D002648:Child; D002675:Child, Preschool; D003457:Cryptosporidiosis / Q000150:complications / Q000188:drug therapy*; D003967:Diarrhea / Q000150:complications / Q000188:drug therapy / Q000453:epidemiology; D005243:Feces / Q000469:parasitology; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009574:Nitro Compounds; D017678:Sex Distribution; D013844:Thiazoles / Q000009:adverse effects / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States / Q000453:epidemiology
D000977:Antiparasitic Agents; D009574:Nitro Compounds; D013844:Thiazoles; C041747:nitazoxanide