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

Primary Purpose

Cryptosporidiosis, HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Diclazuril
Sponsored by
Janssen, LP
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cryptosporidiosis focused on measuring AIDS-Related Opportunistic Infections, Cryptosporidiosis, Diarrhea, diclazuril, Coccidiostats, Acquired Immunodeficiency Syndrome

Eligibility Criteria

12 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Bellevue Hosp / New York Univ Med Ctr
  • Cornell Univ Med Ctr
  • Saint Luke's - Roosevelt Hosp Ctr

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Janssen, LP
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1. Study Identification

Unique Protocol Identification Number
NCT00002278
Brief Title
A 28-Day Study of Diclazuril in the Treatment of Cryptosporidiosis in Patients With AIDS
Official Title
28 Day Protocol for the Treatment of Cryptosporidiosis in AIDS Patients With Diclazuril (R64,433)
Study Type
Interventional

2. Study Status

Record Verification Date
July 1990
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Janssen, LP

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cryptosporidiosis, HIV Infections
Keywords
AIDS-Related Opportunistic Infections, Cryptosporidiosis, Diarrhea, diclazuril, Coccidiostats, Acquired Immunodeficiency Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Diclazuril

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Bellevue Hosp / New York Univ Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Cornell Univ Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Saint Luke's - Roosevelt Hosp Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10025
Country
United States

12. IPD Sharing Statement

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

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