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| Tracking Information | |
|---|---|
| First Received Date ICMJE | November 2, 1999 |
| Last Updated Date | June 23, 2005 |
| Start Date ICMJE | |
| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE | |
| Change History | Complete list of historical versions of study NCT00002278 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| Descriptive Information | |
| Brief Title ICMJE | A 28-Day Study of Diclazuril in the Treatment of Cryptosporidiosis in Patients With AIDS |
| Official Title ICMJE | 28 Day Protocol for the Treatment of Cryptosporidiosis in AIDS Patients With Diclazuril (R64,433) |
| 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. |
| Detailed Description | |
| Study Phase | |
| Study Type ICMJE | Interventional |
| Study Design ICMJE | Treatment |
| Condition ICMJE |
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| Intervention ICMJE | Drug: Diclazuril |
| Study Arms / Comparison Groups | |
| Publications * | |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | |
| Completion Date | |
| Primary Completion Date | |
| Eligibility Criteria ICMJE | Inclusion Criteria Concurrent Medication: Allowed:
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.
Prior Medication: Allowed:
Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded:
Concurrent Medication: Excluded:
Patients with the following are excluded:
Prior Medication: Excluded:
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| Gender | Both |
| Ages | 12 Years to 65 Years |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT ID ICMJE | NCT00002278 |
| Responsible Party | |
| Study ID Numbers ICMJE | 038B, JRD 64,433/1102 |
| Study Sponsor ICMJE | Janssen, LP |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | NIH AIDS Clinical Trials Information Service |
| Verification Date | July 1990 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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