Nitazoxanide for the Treatment of Chronic Diarrhea in HIV Infected Children (NCT00055107) | Clinical Trial Compass
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 range
3 Months – 19 Years
Sex
ALL
See this in plain English?
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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
2
area under the curve (AUC) of orally administered NTZ
Trial details
NCT IDNCT00055107
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)