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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00004986
First Posted: August 31, 2001
Last Update Posted: June 24, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
NIH AIDS Clinical Trials Information Service
  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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years and older   (Child, Adult, Senior)
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004986


Locations
United States, Florida
Julie Ryner
Tampa, Florida, United States, 33607
Sponsors and Collaborators
Romark Laboratories L.C.
  More Information

ClinicalTrials.gov Identifier: NCT00004986     History of Changes
Other Study ID Numbers: 253C
RM-NTZ-99-003
First Submitted: March 16, 2000
First Posted: August 31, 2001
Last Update Posted: June 24, 2005
Last Verified: August 2000

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
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Intestinal Diseases, Parasitic
Parasitic Diseases
Protozoan Infections, Animal
Parasitic Diseases, Animal
Coccidiosis
Protozoan Infections
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Nitazoxanide
Antiparasitic Agents
Anti-Infective Agents