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. doi: 10.1111/j.1365-2036.2006.03033.x.


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 (> 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.

Publication types

  • Clinical Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • AIDS-Related Opportunistic Infections / complications
  • AIDS-Related Opportunistic Infections / drug therapy*
  • AIDS-Related Opportunistic Infections / epidemiology
  • Adolescent
  • Adult
  • Age Distribution
  • Aged
  • Antiparasitic Agents / adverse effects
  • Antiparasitic Agents / therapeutic use*
  • CD4 Lymphocyte Count
  • Child
  • Child, Preschool
  • Cryptosporidiosis / complications
  • Cryptosporidiosis / drug therapy*
  • Diarrhea / complications
  • Diarrhea / drug therapy
  • Diarrhea / epidemiology
  • Feces / parasitology
  • Female
  • Humans
  • Male
  • Middle Aged
  • Nitro Compounds
  • Sex Distribution
  • Thiazoles / adverse effects
  • Thiazoles / therapeutic use*
  • Time Factors
  • Treatment Outcome
  • United States / epidemiology


  • Antiparasitic Agents
  • Nitro Compounds
  • Thiazoles
  • nitazoxanide