Nitazoxanide for the Treatment of Chronic Diarrhea in HIV Infected Children

• Status: Completed
• Trial end date: 2006-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Treatments: Nitazoxanide

Criteria

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