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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002278
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: July 1990
  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

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: 28 Day Protocol for the Treatment of Cryptosporidiosis in AIDS Patients With Diclazuril (R64,433)

Resource links provided by NLM:


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

  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
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: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00002278     History of Changes
Other Study ID Numbers: 038B, JRD 64,433/1102
Study First Received: November 2, 1999
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
Diarrhea
diclazuril
Coccidiostats
Acquired Immunodeficiency Syndrome

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

ClinicalTrials.gov processed this record on July 22, 2014