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Clinical Trials

MainTitle

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

This study has been terminated
Sponsor
Romark Laboratories L.C.


Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier
NCT00004986

First received: March 16, 2000
Last updated: June 23, 2005
Last Verified: August 2000
History of Changes
Purpose

Purpose

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

Condition Intervention Phase
Cryptosporidiosis
HIV Infections

Drug : Nitazoxanide
Phase 3

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Open Label, Multi-Center Evaluation of Nitazoxanide for the Treatment of Cryptosporidiosis in Subjects With AIDS in the United States

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment: 30
Study Start Date: February 2000

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.

Eligibility

Eligibility

Ages Eligible for Study: 13 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

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.

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004986

Locations

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

Sponsors and Collaborators

Romark Laboratories L.C.
More Information

More Information


Responsible Party: Romark Laboratories L.C.  
ClinicalTrials.gov Identifier: NCT00004986   History of Changes  
Other Study ID Numbers: 253C  
  RM-NTZ-99-003  
Study First Received: March 16, 2000  
Last Updated: June 23, 2005  

Keywords provided by NIH AIDS Clinical Trials Information Service:

AIDS-Related Opportunistic Infections
Cryptosporidiosis
Drug Evaluation
Antiprotozoal Agents
Treatment Failure
nitazoxanide

Additional relevant MeSH terms:
HIV Infections
Cryptosporidiosis
Nitazoxanide

ClinicalTrials.gov processed this data on October 23, 2017
This information is provided by ClinicalTrials.gov.