Safety and Effectiveness of Nitazoxanide for the Treatment of Cryptosporidiosis in AIDS Patients

Official Title: “Open Label, Multi-Center Evaluation of Nitazoxanide for the Treatment of Cryptosporidiosis in Subjects With AIDS in the United States”

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

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.

Intervention(s) in this Clinical Trial

• Drug: Nitazoxanide

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 13 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Romark Laboratories L.C. Industry

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00004986

Study ID Number: 253C

ClinicalTrials.gov Identifier: NCT00004986

Health Authority: United States: Food and Drug Administration