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

HIV Infections Clinical Trial

Official title:

28 Day Protocol for the Treatment of Cryptosporidiosis in AIDS Patients With Diclazuril (R64,433)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002278
• Other study ID #: 038B
• Secondary ID: JRD 64,433/1102
• Status: Completed
• Phase: N/A
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: July 1990
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 65 Years

Eligibility

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.

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cryptosporidiosis
• HIV Infections

Intervention

Drug:
• Diclazuril

Locations

Country	Name	City	State
United States	Bellevue Hosp / New York Univ Med Ctr	New York	New York
United States	Cornell Univ Med Ctr	New York	New York
United States	Saint Luke's - Roosevelt Hosp Ctr	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Janssen, LP

Country where clinical trial is conducted

United States,