Safety and Effectiveness of Nitazoxanide for the Treatment of Cryptosporidiosis in AIDS Patients
Romark Laboratories L.C.
Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service
First received: March 16, 2000
Last updated: June 23, 2005
Last Verified: August 2000
History of Changes
The purpose of this study is to see if it is safe and effective to treat cryptosporidiosis in AIDS patients with nitazoxanide.
Drug : Nitazoxanide
Primary Purpose: Treatment
|Official Title:||Open Label, Multi-Center Evaluation of Nitazoxanide for the Treatment of Cryptosporidiosis in Subjects With AIDS in the United States|
Further study details as provided by NIH AIDS Clinical Trials Information Service:
|Study Start Date:||February 2000|
Patients take nitazoxanide daily for 8 weeks with a dose escalation after the first 4 weeks. Patients return to the hospital for examinations every 2 weeks during the 8-week treatment period and 6-week follow-up. Nitazoxanide therapy is discontinued in patients showing a complete clinical and parasitologic response (therapeutic cure) after 8 weeks of treatment and in patients showing a therapeutic cure at two consecutive visits (Weeks 2 and 4 or Weeks 4 and 6). These patients undergo a physical examination including stool analysis for Cryptosporidium parvum oocysts and routine laboratory tests at Weeks 2, 4, and 6 after completion of nitazoxanide therapy. Patients who do not show a complete clinical and parasitologic response (therapeutic failure) after 8 weeks of treatment are allowed to remain on nitazoxanide therapy through the Open Label Compassionate Use of Nitazoxanide in Treatment of Cryptosporidiosis in AIDS Patients (UMD-95-009) protocol.Eligibility
|Ages Eligible for Study:||13 Years and older|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
Patients may be eligible for this study if they:
- Are HIV-positive.
- Have a CD4 cell count of 50 cells/mm3 or less.
- Have evidence of cryptosporidium infection in their stool sample within 10 days of study entry.
- Have watery stools at least three times a day at least 5 days a week for 21 days prior to enrollment.
- Are able to take medications by mouth.
- Are at least 13 years old (consent of parent or guardian required if under 18).
- Agree to use an effective method of birth control (such as condoms) during the study.
- Have certain diseases or infections of the intestines.
- Have ever taken nitazoxanide.
- Have taken certain experimental drugs within 14 days of enrollment.
- Will need to take certain other medications during the study such as paromomycin, azithromycin, and clarithromycin.
- Have started a new anti-HIV therapy within 4 weeks of study entry or plan on starting one during the study.
- Are pregnant or breast-feeding.
Patients will not be eligible 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: NCT00004986
Locations Show More
|United States, Florida|
|Tampa, Florida, United States, 33607|
Sponsors and CollaboratorsRomark Laboratories L.C.
|Responsible Party:||Romark Laboratories L.C.|
|ClinicalTrials.gov Identifier:||NCT00004986 History of Changes|
|Other Study ID Numbers:||253C|
|Study First Received:||March 16, 2000|
|Last Updated:||June 23, 2005|
Keywords provided by NIH AIDS Clinical Trials Information Service:AIDS-Related Opportunistic Infections
Additional relevant MeSH terms:
ClinicalTrials.gov processed this data on January 18, 2018
This information is provided by ClinicalTrials.gov.