High dose prolonged treatment with nitazoxanide is not effective for cryptosporidiosis in HIV positive Zambian children: a randomised controlled trial

BMC Infect Dis. 2009 Dec 2;9:195. doi: 10.1186/1471-2334-9-195.

Abstract

Background: Treatment of cryptosporidiosis in HIV infected children has proved difficult and unsatisfactory with no drugs having demonstrable efficacy in controlled trials except nitazoxanide. We hypothesised that a prolonged course of treatment with high dose nitazoxanide would be effective in treating cryptosporidiosis in HIV positive Zambian children.

Methods: We performed a double-blind, randomised, placebo controlled trial in paediatric patients in the UTH in Lusaka. The study included HIV positive children between one and eleven years of age if 2 out of 3 stool samples were positive for oocysts of Cryptosporidium spp. Children were given nitazoxanide suspension in a dose of 200 mg twice daily (bid) for 28 days (if 1-3 years old) or 400 mg bid for 28 days (if 4-11 years old), or matching placebo.

Results: Sixty children were randomised and 52 were fully evaluated. Only five children were 4 years of age or over and received the higher dose. In the primary efficacy analysis, 11 out of 26 (42%) in the active treatment group achieved a 'Well' clinical response compared to 8 out of 26 (35%) in the placebo group. Parasitological response was declared as 'Eradicated' in 27% in the active group and 35% in the placebo group. Mortality (16/52, 31%) did not differ by treatment allocation.

Conclusion: We found no significant benefit in children with cryptosporidiosis despite high dose and longer treatment duration. This is the second randomised controlled trial to suggest that in Zambian children with HIV-related immunosuppression nitazoxanide does not eradicate this infection nor provide clinical symptom reduction.

Trial registration: The trial was registered as ISRCTN41089957.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Antiparasitic Agents / therapeutic use*
  • Child, Preschool
  • Cryptosporidiosis / drug therapy*
  • Double-Blind Method
  • Female
  • HIV Seropositivity / complications*
  • Humans
  • Infant
  • Male
  • Thiazoles / therapeutic use*
  • Treatment Outcome
  • Zambia

Substances

  • Antiparasitic Agents
  • Thiazoles
  • nitazoxanide

Associated data

  • ISRCTN/ISRCTN41089957