- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002158
A Study to Evaluate the Use of Nitazoxanide to Treat Cryptosporidiosis
July 9, 2007 updated by: Romark Laboratories L.C.
Open-Label Compassionate Use of Nitazoxanide for the Treatment of Cryptosporidiosis in AIDS Patients
The purpose of this study is to see if nitazoxanide (NTZ) can be used to treat AIDS patients suffering from cryptosporidiosis (diarrhea caused by the parasite Cryptosporidium).
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Patients receive oral nitazoxanide daily for 14 days, after which those with complete clinical and parasitologic response discontinue treatment.
Non-responders and partial responders may continue therapy for an additional 14 days at the discretion of the physician.
Non-responders who show signs of improvement or who have partial response after 28 days and those who relapse following complete response may continue therapy for an additional month, up to 60 days total.
[AS PER AMENDMENT 10/30/96: Patients receive a daily treatment for 4 weeks, with subsequent dose escalation in the absence of drug-related toxicity.
Patients who exhibit complete response after 2 months may continue at a maintenance dose.
Patients enrolled after October 15, 1996 are randomized to 1 of 2 doses, with subsequent escalations made in the absence of toxicity.
Complete responders may continue therapy at a maintenance dose and duration determined by the investigator.
Non-responders after 6 months of therapy have treatment discontinued.]
[AS PER AMENDMENT 8/5/97: All patients are evaluated at Weeks 1, 2, 4, and monthly thereafter.]
[AS PER AMENDMENT 8/17/99: New patients start therapy on a different dosage of nitazoxanide.
Those who do not respond after 4 weeks of therapy will escalate to a higher dosage.
Patients who show a complete response at 2 consecutive visits (2 weeks apart) discontinue nitazoxanide therapy and go to follow-up.]
[AS PER AMENDMENT 2/3/00: The Week 1 clinical evaluation is deleted from the study procedures.]
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Tampa, Florida, United States, 33607
- Romark Laboratories LC
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years to 65 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria
Patients may be eligible for this study if they:
- Are 3 to 65 years old (need consent of parent or guardian if under 18).
- Have AIDS.
- Have a CD4 count less than or equal to 200 cells/mm3. (Note: Patients with a CD4 count greater than 200 cells/mm3 but who have had cryptosporidiosis for at least 4 weeks may be eligible for this study.)
- Test positive for the parasite Cryptosporidium and have severe diarrhea (at least 4 bowel movements per day) for at least 2 weeks.
- Have received treatment for cryptosporidiosis but have become reinfected after treatment.
- Agree to practice abstinence or use effective methods of birth control (such as a condom) before and during the study.
Exclusion Criteria
Patients will not be eligible for this study if they:
- Are pregnant.
- Are infected with certain other parasites.
- Have a history of certain intestinal diseases.
- Have received certain medications.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
November 2, 1999
First Submitted That Met QC Criteria
August 30, 2001
First Posted (Estimate)
August 31, 2001
Study Record Updates
Last Update Posted (Estimate)
July 10, 2007
Last Update Submitted That Met QC Criteria
July 9, 2007
Last Verified
July 1, 2007
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 253B
- UMD-95-009
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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