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

June 23, 2005 updated by: Romark Laboratories L.C.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment

30

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33607
        • Julie Ryner

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Romark Laboratories L.C.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2000

Study Registration Dates

First Submitted

March 16, 2000

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

August 1, 2000

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 253C
  • RM-NTZ-99-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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