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A Study to Evaluate the Use of Nitazoxanide to Treat Cryptosporidiosis
This study is ongoing, but not recruiting participants.
Sponsored by: Romark Laboratories L.C.
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002158
  Purpose

The purpose of this study is to see if nitazoxanide (NTZ) can be used to treat AIDS patients suffering from cryptosporidiosis (diarrhea caused by the parasite Cryptosporidium).


Condition Intervention
Cryptosporidiosis
HIV Infections
Drug: Nitazoxanide

MedlinePlus related topics: AIDS Cryptosporidiosis Diarrhea
Drug Information available for: Nitazoxanide
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: Open-Label Compassionate Use of Nitazoxanide for the Treatment of Cryptosporidiosis in AIDS Patients

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

Detailed Description:

Patients receive oral nitazoxanide daily for 14 days, after which those with complete clinical and parasitologic response discontinue treatment. Non-responders and partial responders may continue therapy for an additional 14 days at the discretion of the physician. Non-responders who show signs of improvement or who have partial response after 28 days and those who relapse following complete response may continue therapy for an additional month, up to 60 days total. [AS PER AMENDMENT 10/30/96: Patients receive a daily treatment for 4 weeks, with subsequent dose escalation in the absence of drug-related toxicity. Patients who exhibit complete response after 2 months may continue at a maintenance dose. Patients enrolled after October 15, 1996 are randomized to 1 of 2 doses, with subsequent escalations made in the absence of toxicity. Complete responders may continue therapy at a maintenance dose and duration determined by the investigator. Non-responders after 6 months of therapy have treatment discontinued.] [AS PER AMENDMENT 8/5/97: All patients are evaluated at Weeks 1, 2, 4, and monthly thereafter.] [AS PER AMENDMENT 8/17/99: New patients start therapy on a different dosage of nitazoxanide. Those who do not respond after 4 weeks of therapy will escalate to a higher dosage. Patients who show a complete response at 2 consecutive visits (2 weeks apart) discontinue nitazoxanide therapy and go to follow-up.] [AS PER AMENDMENT 2/3/00: The Week 1 clinical evaluation is deleted from the study procedures.]

  Eligibility

Ages Eligible for Study:   3 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

Patients may be eligible for this study if they:

  • Are 3 to 65 years old (need consent of parent or guardian if under 18).
  • Have AIDS.
  • Have a CD4 count less than or equal to 200 cells/mm3. (Note: Patients with a CD4 count greater than 200 cells/mm3 but who have had cryptosporidiosis for at least 4 weeks may be eligible for this study.)
  • Test positive for the parasite Cryptosporidium and have severe diarrhea (at least 4 bowel movements per day) for at least 2 weeks.
  • Have received treatment for cryptosporidiosis but have become reinfected after treatment.
  • Agree to practice abstinence or use effective methods of birth control (such as a condom) before and during the study.

Exclusion Criteria

Patients will not be eligible for this study if they:

  • Are pregnant.
  • Are infected with certain other parasites.
  • Have a history of certain intestinal diseases.
  • Have received certain medications.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002158

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

Study ID Numbers: 253B, UMD-95-009
Study First Received: November 2, 1999
Last Updated: July 9, 2007
ClinicalTrials.gov Identifier: NCT00002158  
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Cryptosporidiosis
Diarrhea
Acquired Immunodeficiency Syndrome
nitazoxanide
Antiparasitic Agents

Study placed in the following topic categories:
Protozoan Infections
Sexually Transmitted Diseases, Viral
Diarrhea
Gastrointestinal Diseases
Acquired Immunodeficiency Syndrome
Intestinal Diseases
Immunologic Deficiency Syndromes
Virus Diseases
Cryptosporidiosis
Digestive System Diseases
HIV Infections
Sexually Transmitted Diseases
Parasitic Diseases
Nitazoxanide
Intestinal Diseases, Parasitic
Retroviridae Infections

Additional relevant MeSH terms:
Anti-Infective Agents
Antiparasitic Agents
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Coccidiosis
Therapeutic Uses
Lentivirus Infections
Parasitic Diseases, Animal
Protozoan Infections, Animal
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009