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A 28-Day Study of Diclazuril in the Treatment of Cryptosporidiosis in Patients With AIDS

This study has been completed.

Sponsored by: Janssen, LP
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002278
  Purpose

To evaluate the safety and efficacy of diclazuril capsules as a treatment for cryptosporidial related diarrhea in AIDS patients who have been treated in the double-blind study # JRD 64,433/1101 and have relapsed, or de-novo patients who have been diagnosed with cryptosporidial related diarrhea and who meet the inclusion and exclusion criteria of this protocol.


Condition Intervention
Cryptosporidiosis
HIV Infections
Drug: Diclazuril

MedlinePlus related topics:   AIDS    Cryptosporidiosis    Diarrhea   

ChemIDplus related topics:   Diclazuril   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   28 Day Protocol for the Treatment of Cryptosporidiosis in AIDS Patients With Diclazuril (R64,433)
  Eligibility
Ages Eligible for Study:   12 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

  • Zidovudine (AZT).
  • Didanosine (ddI) allowed but discouraged, must have been stabilized on a constant dose for 3 weeks or more.
  • Aerosolized pentamidine.
  • Nystatin for control of oropharyngeal infections. Nystatin must not be taken within two hours of diclazuril.
  • Ganciclovir therapy only for CMV retinitis is permitted if the patient has been treated for at least 4 weeks prior to study entry and is stable on the drug.
  • Loperamide may be taken if patient has been on long term loperamide prior to study entry but should not be started during the course of this protocol.

Patients must have the following:

Written informed consent given after the purpose and nature of the study, as well as the possible adverse effects related to the study drug, have been explained.

  • Be willing and able to return for all subsequent weekly visits and the two week visit post completion of therapy (follow-up).

Prior Medication:

Allowed:

  • Diclazuril.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

  • Uncontrolled vomiting.
  • Estimated survival less than 28 days.
  • Other treatable enteric pathogens must be treated and eradicated prior to study entry.

Concurrent Medication:

Excluded:

  • Amphotericin B.
  • Other antibiotics or antiprotozoal drugs.
  • Other investigational agents.
  • Trimethoprim/sulfamethoxazole.
  • Antifungal medications except nystatin.
  • Ganciclovir for other than Cytomegalovirus (CMV) retinitis.
  • Antidiarrheal agents other than patients on long term loperamide prior to study entry.

Patients with the following are excluded:

  • Undependable in following the instructions of the investigator.
  • Not able to swallow capsules.
  • Uncontrolled vomiting.
  • Estimated survival less than 28 days.

Prior Medication:

Excluded:

  • Diclazuril within 2 weeks of study entry.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002278

Locations
United States, New York
Bellevue Hosp / New York Univ Med Ctr    
      New York, New York, United States, 10016
Cornell Univ Med Ctr    
      New York, New York, United States, 10021
Saint Luke's - Roosevelt Hosp Ctr    
      New York, New York, United States, 10025

Sponsors and Collaborators
Janssen, LP
  More Information


Study ID Numbers:   038B, JRD 64,433/1102
First Received:   November 2, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00002278
Health Authority:   United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
AIDS-Related Opportunistic Infections  
Cryptosporidiosis  
Diarrhea  
diclazuril
Coccidiostats
Acquired Immunodeficiency Syndrome

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

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

ClinicalTrials.gov processed this record on September 16, 2008




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