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A Study to Evaluate the Use of Nitazoxanide to Treat Cryptosporidiosis (Diarrhea Caused by the Parasite Cryptosporidium) Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on A Study to Evaluate the Use of Nitazoxanide to Treat Cryptosporidiosis (Diarrhea Caused by the Parasite Cryptosporidium) conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. A Study to Evaluate the Use of Nitazoxanide to Treat Cryptosporidiosis (Diarrhea Caused by the Parasite Cryptosporidium) Clinical research trials and A Study to Evaluate the Use of Nitazoxanide to Treat Cryptosporidiosis (Diarrhea Caused by the Parasite Cryptosporidium) healthcare trials take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including A Study to Evaluate the Use of Nitazoxanide to Treat Cryptosporidiosis (Diarrhea Caused by the Parasite Cryptosporidium). A Study to Evaluate the Use of Nitazoxanide to Treat Cryptosporidiosis (Diarrhea Caused by the Parasite Cryptosporidium) Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a A Study to Evaluate the Use of Nitazoxanide to Treat Cryptosporidiosis (Diarrhea Caused by the Parasite Cryptosporidium) clinical trial. Test subjects oftentimes recieve the best healthcare possible for their A Study to Evaluate the Use of Nitazoxanide to Treat Cryptosporidiosis (Diarrhea Caused by the Parasite Cryptosporidium) condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.

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A Study to Evaluate the Use of Nitazoxanide to Treat Cryptosporidiosis (Diarrhea Caused by the Parasite Cryptosporidium)



A Study to Evaluate the Use of Nitazoxanide to Treat Cryptosporidiosis (Diarrhea Caused by the Parasite Cryptosporidium)

For Condition: Cryptosporidiosis,HIV Infections
Status: Recruiting
Sponsor(s): Romark Laboratories L.C. ,
Synopsis: 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).
Details: 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.]
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 3 Years/65 Years
Genders: Both
Protocol Entry Criteria: 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.
Total Enrollment: 

Location and Contact Information:

Romark Laboratories LC *Recruiting*
Tampa,  Florida,  33607
United States
Recruiting Heidi  Ano


Additional Information:
Study ID Numbers:  253B;  UMD-95-009
Study Start Date: 
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002158

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