Double-blind, placebo-controlled study of nitazoxanide suspension in the treatment of cryptosporidiosis in children with HIV

High dose prolonged treatment with nitazoxanide for the treatment of cryptosporidiosis in children with HIV: a double-blind, randomised placebo-controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN41089957

Enrollment

Registered

2008-06-16

Start date

2002-06-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV-related opportunistic infection/ cryptosporidiosis Infections and Infestations Other protozoal intestinal diseases

Interventions

Nitazoxanide suspension: 200 mg twice a day (bid) for 28 days (if 1-3 years old) or 400 mg bid for 28 days (if 4-11 years old), or matching placebo. Total duration of follow-up: 4 weeks. However, a

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Both males and females, age 1-11 years 2. Stool positive for Cryptosporidium parvum using the auramine phenol staining technique (specimen collected within 7 days prior to enrolment) 3. Patients with diarrhoea (>= 3 unformed stools/day) for each of the 5 days prior to enrolment based on report by the patient, parent or guardian and observation in hospital for at least 24 hours 4. Patients who are HIV positive by the Capillus Rapid Test (Trinity Biotech, Ireland)

Exclusion criteria

Exclusion criteria: 1. Any investigational drug therapy within 1 month of enrolment 2. Use within 2 weeks of enrolment of metronidazole, tinidazole, ornidazole, secnidazole, hydroxyquinoline derivatives, diloxanide, paromomycin or nitazoxanide 3. Patients with positive enzyme immunoassay of faecal sample for Entamoeba histolytica or Giardia lamblia 4. Serious systemic disorders incompatible with the study

Design outcomes

Primary

Measure	Time frame
Proportion of children achieving 'well' clinical response and time to 'well' clinical response. Well response is defined as the patient experiencing no symptoms of C. parvum infection and passing no watery stools within the previous 48 hours.	—

Secondary

Measure	Time frame
1. Proportion of children achieving eradication of oocysts of C. parvum from two consecutive stool samples, and time to eradication 2. Time to well clinical response and eradication of oocysts from the stool 3. Mortality at 4 weeks 4. Rate of reduction in diarrhoea frequency based on daily evaluation over 4 weeks 5. Nutritional response (change over time in weight for age z scores, weight for height z scores, height for age z scores and mid-upper arm circumference) based on daily evaluation over 4 weeks	—

Measure

Time frame

1. Proportion of children achieving eradication of oocysts of C. parvum from two consecutive stool samples, and time to eradication 2. Time to well clinical response and eradication of oocysts from the stool 3. Mortality at 4 weeks 4. Rate of reduction in diarrhoea frequency based on daily evaluation over 4 weeks 5. Nutritional response (change over time in weight for age z scores, weight for height z scores, height for age z scores and mid-upper arm circumference) based on daily evaluation over 4 weeks

—

Countries

Zambia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 1, 2026