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

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Romark Laboratories L.C.
• Treatments: Nitazoxanide

Criteria

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.