Expired Study
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Tampa, Florida 33607


The purpose of this study is to see if it is safe and effective to treat cryptosporidiosis in AIDS patients with nitazoxanide.

Study summary:

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.


Inclusion Criteria 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. Exclusion Criteria Patients will not be eligible if they: - 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.



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Tampa, Florida 33607
United States

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Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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