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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

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00002278 on ClinicalTrials.gov Archive Site
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A 28-Day Study of Diclazuril in the Treatment of Cryptosporidiosis in Patients With AIDS
28 Day Protocol for the Treatment of Cryptosporidiosis in AIDS Patients With Diclazuril (R64,433)

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.

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Interventional
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Primary Purpose: Treatment
  • Cryptosporidiosis
  • HIV Infections
Drug: Diclazuril
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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.
Both
12 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002278
038B, JRD 64,433/1102
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Janssen, LP
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NIH AIDS Clinical Trials Information Service
July 1990

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP