Abstract
BackgroundTreatment 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.MethodsWe 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.ResultsSixty 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.ConclusionWe 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 RegistrationThe trial was registered as ISRCTN41089957.
Highlights
Treatment of cryptosporidiosis in HIV infected children has proved difficult and unsatisfactory with no drugs having demonstrable efficacy in controlled trials except nitazoxanide
If Cryptosporidium spp. oocysts were present in the initial screening but not in the baseline samples, the patient was excluded unless they tested positive for oocysts within one week from this first sample
Of 409 children with cryptosporidiosis identified during the duration of the trial, 130 did not meet the entry criteria, 122 declined, 129 seriously ill children died during the period of observation and 28 withdrew before randomisation (Figure 1)
Summary
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. Treatment remains difficult and unsatisfactory, with no drugs having any proven efficacy except nitazoxanide [5,6,7]. We have previously reported that three day treatment with the antiparasitic drug nitazoxanide was effective in treatment of HIV-seronegative children but demonstrated insignificant activity in HIV-seropositive children [8]. There is an urgent need for effective treatment for cryptosporidiosis in HIV-infected children [9]. The doses of nitazoxanide chosen were double those used in the previous study, and the duration was increased from 3 to 14 days.
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