Search / Trial NCT00002444

A Study of Nitazoxanide in the Treatment of AIDS-Related Diarrhea

Launched by UNIMED PHARMACEUTICALS · Aug 30, 2001

Trial Information

Current as of December 07, 2024

Completed

Keywords

ClinConnect Summary

Cryptosporidial enterocolitis in AIDS patients is frequently chronic and severe, contributing substantially to morbidity, mortality, and health care costs in this population. NTZ exhibits antimicrobial activity that may extend to Cryptosporidial infection.

Patients are enrolled in groups of 7. Group A receives the lowest dose of NTZ. Groups B - D receive sequentially higher doses. Patients in Groups B - D do not begin therapy until all patients have been enrolled at the preceding dose. For determination of single-dose pharmacokinetics, patients receive a single dose of NTZ on Day 1 and blo...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria
  • Patients must have:
  • AIDS diagnosis according to CDC criteria.
  • CD4 count less than or equal to 200 cells/mm3 or CD4 count greater than or equal to 200 cells/mm3 and documented cryptosporidiosis for a minimum of 4 weeks.
  • * Cryptosporidial diarrhea as defined by:
  • (1) presence of Cryptosporidium oocytes in a stool specimen within 14 days of enrollment; and (2) chronic diarrhea (i.e., an average of at least 4 bowel movements per day for a minimum of 2 weeks).
  • Life expectancy of at least 1 month.
  • Ability to tolerate food by mouth.
  • Prior Medication:
  • Required:
  • Any anti-diarrheal or anti-emetic medication for which the dosage regimen has been stable for at least 1 week prior to enrollment.
  • Any antiretroviral medications (e.g., zidovudine, ddI, ddC) for which the dosage regimen has been stable for at least 3 weeks prior to enrollment.
  • Allowed:
  • Medication for prophylaxis or maintenance therapy of opportunistic infection, stable for at least 2 weeks prior to enrollment.
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following symptoms or conditions are excluded:
  • Grade 4 (hematologic) or Grade 3 (for all others) toxicity. (Patients with Grade 3 toxicity for hepatic parameters may be enrolled if, in the investigator's judgment, the abnormalities are due to biliary cryptosporidiosis.)
  • Patients with the following prior conditions are excluded:
  • Presence of Salmonella, Shigella, Campylobacter, Yersinia, Giardia lamblia, Entamoeba histolytica, Microsporidia, Isospora, Cyclospora, or Clostridium difficile toxin in stool (based on assessment within 14 days prior to enrollment by stool ova and parasite examination, culture, and C. difficile assay).
  • History of intestinal Mycobacterium avium intracellular infection or intestinal Kaposi's sarcoma.
  • History of Cytomegalovirus colitis, unless 28 days of therapy with ganciclovir or foscarnet completed subsequent to diagnosis.
  • Prior Medication:
  • Excluded:
  • Investigational drug therapy within 14 days of enrollment, unless available under an FDA-authorized expanded access program.
  • Any drug or therapy with possible anticryptosporidial activity (e.g., paromomycin, spiramycin, azithromycin, clarithromycin, hyperimmune bovine colostrum) within 14 days of enrollment.

Trial Officials

Rosemary Soave

Principal Investigator

About Unimed Pharmaceuticals

Unimed Pharmaceuticals is a leading clinical trial sponsor dedicated to advancing innovative therapeutics in the pharmaceutical industry. With a focus on research and development, Unimed collaborates with healthcare professionals and regulatory bodies to conduct rigorous clinical studies that prioritize patient safety and efficacy. Leveraging cutting-edge technology and a commitment to ethical practices, the company aims to deliver breakthrough treatments that address unmet medical needs across various therapeutic areas. Unimed's experienced team is dedicated to fostering partnerships that enhance the drug development process and improve health outcomes globally.

Locations

New York, New York, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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