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.
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Authors | Beatrice Amadi, Mwiya Mwiya, Sandie Sianongo, Lara Payne, Angela Watuka, Max Katubulushi, Paul Kelly |
Journal | BMC infectious diseases
(BMC Infect Dis)
Vol. 9
Pg. 195
(Dec 02 2009)
ISSN: 1471-2334 [Electronic] England |
PMID | 19954529
(Publication Type: Journal Article, Randomized Controlled Trial)
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Chemical References |
- Antiparasitic Agents
- Nitro Compounds
- Thiazoles
- nitazoxanide
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Topics |
- Antiparasitic Agents
(therapeutic use)
- Child, Preschool
- Cryptosporidiosis
(drug therapy)
- Double-Blind Method
- Female
- HIV Seropositivity
(complications)
- Humans
- Infant
- Male
- Nitro Compounds
- Thiazoles
(therapeutic use)
- Treatment Outcome
- Zambia
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