CompletedPhase 1/2

Nitazoxanide for the Treatment of Chronic Diarrhea in HIV Infected Children

South Africa, Thailand6 participants

Plain-language summary

Cryptosporidium parvum (C. parvum) is a parasite that can cause chronic diarrhea and is a significant problem for HIV infected children in developing countries. C. parvum infection can be treated with the drug nitazoxanide (NTZ). However, NTZ has not been tested in HIV infected children. The purpose of this study is to test the safety of NTZ in HIV infected children who have chronic diarrhea caused by C. parvum. Study hypothesis: Twice-daily NTZ is safe and well tolerated in HIV infected infants, children, and adolescents with chronic diarrhea caused by C. parvum infection.

Who can participate

Age range3 Months – 19 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria for Step 1: * HIV infected * Chronic diarrhea with 3 or more bowel movements per day for at least 5 days in the 2 weeks prior to study entry OR 2 or more bowel movements per day for at least 5 days in the 2 weeks prior to study entry if accompanied by dehydration * Documented presence of C. parvum oocysts in stool * Weight of 4.0 kg (8.8 lbs) or more AND less than or equal to the maximum weight for age group as specified in the study protocol * Parent or guardian willing to provide informed consent, if applicable * Willing to use acceptable forms of contraception Exclusion Criteria for Step 1: * Inability to take liquid or tablet form of medication * Serum transaminase (ALT) and bilirubin greater than or equal to 5 times the upper limit of normal at study screening * Active M. avium intracellulare or cytomegalovirus (CMV) colitis * Active cancer * Certain medications * Pregnant or breastfeeding

What they're measuring

Safety as evaluated by Grade 4 or new Grade 3 adverse reactions before Day 56 that cannot be directly attributed to another cause and are considered treatment limiting

area under the curve (AUC) of orally administered NTZ

Trial details

NCT IDNCT00055107

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

Sponsor typeNIH

Study typeINTERVENTIONAL