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

This study has been terminated.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00004986
First received: March 16, 2000
Last updated: June 23, 2005
Last verified: August 2000
  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: Endpoint Classification: Safety Study
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

Resource links provided by NLM:


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

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
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
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

No publications provided

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
Health Authority: United States: Food and Drug Administration

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:
Acquired Immunodeficiency Syndrome
Cryptosporidiosis
HIV Infections
Infection
Coccidiosis
Digestive System Diseases
Gastrointestinal Diseases
Immune System Diseases
Immunologic Deficiency Syndromes
Intestinal Diseases
Intestinal Diseases, Parasitic
Lentivirus Infections
Parasitic Diseases
Parasitic Diseases, Animal
Protozoan Infections
Protozoan Infections, Animal
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Nitazoxanide
Anti-Infective Agents
Antiparasitic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014