A 28-Day Study of Diclazuril in the Treatment of Cryptosporidiosis in Patients With AIDS
NCT ID: NCT00002278
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
INTERVENTIONAL
Brief Summary
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Detailed Description
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Conditions
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Study Design
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TREATMENT
Interventions
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Diclazuril
Eligibility Criteria
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Inclusion Criteria
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
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.
12 Years
65 Years
ALL
No
Sponsors
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Janssen, LP
INDUSTRY
Locations
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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, United States
Countries
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Other Identifiers
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JRD 64,433/1102
Identifier Type: -
Identifier Source: secondary_id
038B
Identifier Type: -
Identifier Source: org_study_id