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


CONCLUSIONS
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.


BACKGROUND
The trial was registered as ISRCTN41089957.
Amadi
Beatrice
B
Tropical Gastroenterology and Nutrition Group, University of Zambia School of Medicine, Lusaka, Zambia. beatriceamadi@ymail.com
Mwiya
Mwiya
M
Sianongo
Sandie
S
Payne
Lara
L
Watuka
Angela
A
Katubulushi
Max
M
Kelly
Paul
P
D000977:Antiparasitic Agents / Q000627:therapeutic use*; D002675:Child, Preschool; D003457:Cryptosporidiosis / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006679:HIV Seropositivity / Q000150:complications*; D006801:Humans; D007223:Infant; D008297:Male; D009574:Nitro Compounds; D013844:Thiazoles / Q000627:therapeutic use*; D016896:Treatment Outcome; D015024:Zambia
D000977:Antiparasitic Agents; D009574:Nitro Compounds; D013844:Thiazoles; C041747:nitazoxanide