- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002278
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)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New York
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New York, New York, United States, 10021
- Cornell Univ Med Ctr
-
New York, New York, United States, 10016
- Bellevue Hosp / New York Univ Med Ctr
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New York, New York, United States, 10025
- Saint Luke's - Roosevelt Hosp Ctr
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Sponsor
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Infections
- Gastrointestinal Diseases
- Intestinal Diseases
- Intestinal Diseases, Parasitic
- Parasitic Diseases
- Protozoan Infections, Animal
- Parasitic Diseases, Animal
- Coccidiosis
- Protozoan Infections
- Cryptosporidiosis
- Anti-Infective Agents
- Antiprotozoal Agents
- Antiparasitic Agents
- Coccidiostats
- Diclazuril
Other Study ID Numbers
- 038B
- JRD 64,433/1102
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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