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| Sponsored by: |
Romark Laboratories L.C. |
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00004986 |
Purpose
The purpose of this study is to see if it is safe and effective to treat cryptosporidiosis in AIDS patients with nitazoxanide.
| Condition | Intervention | Phase |
|
Cryptosporidiosis HIV Infections |
Drug: Nitazoxanide |
Phase III |
| MedlinePlus related topics: | AIDS Cryptosporidiosis |
| Drug Information available for: | Nitazoxanide |
| Study Type: | Interventional |
| Study Design: | Treatment, Safety Study |
| Official Title: | Open Label, Multi-Center Evaluation of Nitazoxanide for the Treatment of Cryptosporidiosis in Subjects With AIDS in the United States |
| Estimated Enrollment: | 30 |
| 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 |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients may be eligible for this study if they:
Exclusion Criteria
Patients will not be eligible if they:
Contacts and Locations
More Information
| Study ID Numbers: | 253C, RM-NTZ-99-003 |
| First Received: | March 16, 2000 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00004986 |
| Health Authority: | United States: Food and Drug Administration |
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