A Study to Evaluate the Use of Nitazoxanide to Treat Cryptosporidiosis
Verified July 2007
Romark Laboratories L.C.
Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service
First received: November 2, 1999
Last updated: July 9, 2007
Last Verified: July 2007
History of Changes
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).
Drug : Nitazoxanide
Primary Purpose: Treatment
|Official Title:||Open-Label Compassionate Use of Nitazoxanide for the Treatment of Cryptosporidiosis in AIDS Patients|
Further study details as provided by NIH AIDS Clinical Trials Information Service:
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
|Ages Eligible for Study:||3 Years to 65 Years|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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.
- Are pregnant.
- Are infected with certain other parasites.
- Have a history of certain intestinal diseases.
- Have received certain medications.
Patients will not be eligible for this study if they:
Contacts and LocationsChoosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002158
Locations Show More
|United States, Florida|
|Romark Laboratories LC|
|Tampa, Florida, United States, 33607|
Sponsors and CollaboratorsRomark Laboratories L.C.
|Responsible Party:||Romark Laboratories L.C.|
|ClinicalTrials.gov Identifier:||NCT00002158 History of Changes|
|Other Study ID Numbers:||253B|
|Study First Received:||November 2, 1999|
|Last Updated:||July 9, 2007|
Keywords provided by NIH AIDS Clinical Trials Information Service:Cryptosporidiosis
Acquired Immunodeficiency Syndrome
Additional relevant MeSH terms:
ClinicalTrials.gov processed this data on September 21, 2018
This information is provided by ClinicalTrials.gov.