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| Sponsor: | Janssen, LP |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002278 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Cryptosporidiosis HIV Infections |
Drug: Diclazuril |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | 28 Day Protocol for the Treatment of Cryptosporidiosis in AIDS Patients With Diclazuril (R64,433) |
Eligibility| Ages Eligible for Study: | 12 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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:
Contacts and Locations| United States, New York | |
| Bellevue Hosp / New York Univ Med Ctr | |
| New York, New York, United States, 10016 | |
| Cornell Univ Med Ctr | |
| New York, New York, United States, 10021 | |
| Saint Luke's - Roosevelt Hosp Ctr | |
| New York, New York, United States, 10025 | |
More Information
| ClinicalTrials.gov Identifier: | NCT00002278 History of Changes |
| Other Study ID Numbers: | 038B, JRD 64,433/1102 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Food and Drug Administration |
|
AIDS-Related Opportunistic Infections Cryptosporidiosis Diarrhea |
diclazuril Coccidiostats Acquired Immunodeficiency Syndrome |
|
HIV Infections Acquired Immunodeficiency Syndrome Cryptosporidiosis Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Intestinal Diseases, Parasitic Parasitic Diseases |
Protozoan Infections, Animal Parasitic Diseases, Animal Coccidiosis Protozoan Infections Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases Diclazuril Coccidiostats Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |