CompletedPhase 2

A Study of Nitazoxanide in Patients With AIDS and Diarrhea Caused by Cryptosporidium

United States60 participants

Plain-language summary

To determine the frequency of complete, marked, and partial clinical responses in patients with cryptosporidiosis treated with 6 weeks of NTZ versus 21 days of placebo. To determine the safety of NTZ in subjects with cryptosporidiosis. There is no proven therapy for cryptosporidiosis in persons with AIDS. Nitazoxanide appears to be a good candidate drug for further evaluation because of its effectiveness in preclinical models, the data from early clinical trials and its safety profile. Cooperation between clinical researchers and basic scientists in clinical trials of agents for HIV infection and its complications is a high priority for the ACTG, the NIAID, and the NIH. Thus, it is important to design a clinical trial of NTZ that includes cooperation with basic scientists.

Who can participate

Age range

13 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 Patients must have: * Documented HIV infection. * Intestinal cryptosporidiosis. * Willingness to undergo a 1 week washout phase of all anticryptosporidial medications and stabilization on a protocol directed, antidiarrheal regimen. * Greater than or equal to 4 stools per day, on average, for a minimum of 21 out of 28 days prior to study entry, secondary to cryptosporidiosis. AS PER AMENDMENT 2/10/97: * Four or more stools per day, on average, during the 5-day screening period prior to baseline. Exclusion Criteria Co-existing Condition: Patients with the following symptoms and conditions are excluded: * Inability to tolerate oral medications. * Life expectancy less than 3 months in the opinion of the investigator. * Active CMV colitis, C. difficile colitis, giardiasis, salmonellosis, shigellosis, campylobacteriosis, inflammatory bowel disease, diarrhea secondary to another documented intestinal pathogen, or active or uncontrolled MAC disease, defined as symptomatic MAC disease and/or a patient who is not on appropriate anti-MAC therapy in the presence of MAC disease. NOTE: * Patients who have been treated for MAC disease for at least 4 weeks and have resolved their symptoms may be enrolled. Patients dually infected with microsporidiosis may be randomized to the study but will not count toward the sample size. AS PER AMENDMENT 2/10/97: * Failure to record a minimum of four days of information on the use of antidiarrheal medication and the frequenc…

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.

Trial details

NCT IDNCT00001081

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

Sponsor typeNIH

Study typeINTERVENTIONAL

View on ClinicalTrials.gov More Cryptosporidiosis trials