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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: | 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
| Study ID Numbers: | 038B, JRD 64,433/1102 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002278 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
AIDS-Related Opportunistic Infections Cryptosporidiosis Diarrhea |
diclazuril Coccidiostats Acquired Immunodeficiency Syndrome |
|
Anti-Infective Agents Communicable Diseases Antiprotozoal Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Gastrointestinal Diseases Infection Antiparasitic Agents Cryptosporidiosis Therapeutic Uses Parasitic Diseases Parasitic Diseases, Animal Coccidiostats Retroviridae Infections Protozoan Infections |
RNA Virus Infections Immune System Diseases Coccidiosis Acquired Immunodeficiency Syndrome Intestinal Diseases Pharmacologic Actions Immunologic Deficiency Syndromes Virus Diseases Digestive System Diseases HIV Infections Sexually Transmitted Diseases Lentivirus Infections Protozoan Infections, Animal Diclazuril Intestinal Diseases, Parasitic |