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

HIV Infections Clinical Trial

Official title:

Open Label, Multi-Center Evaluation of Nitazoxanide for the Treatment of Cryptosporidiosis in Subjects With AIDS in the United States

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00004986
• Other study ID #: 253C
• Secondary ID: RM-NTZ-99-003
• Status: Terminated
• Phase: Phase 3
• First received: March 16, 2000
• Last updated: June 23, 2005
• Start date: February 2000

Study information

• Verified date: August 2000
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cryptosporidiosis
• HIV Infections

Intervention

Drug:
• Nitazoxanide

Locations

Country	Name	City	State
United States	Julie Ryner	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Romark Laboratories L.C.

Country where clinical trial is conducted

United States,