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Study 14 of 19 for search of: | "Cryptosporidiosis" |
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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Janssen, LP |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00001018 |
To determine the pharmacokinetic profile of single doses of letrazuril in patients with AIDS-related cryptosporidial diarrhea; to determine the dose proportionality of single escalating doses of letrazuril; to determine steady-state concentrations of letrazuril; to evaluate the safety and efficacy of escalating doses of letrazuril, compared with placebo, for patients with AIDS-related cryptosporidial diarrhea.
Letrazuril, the p-fluor analog of diclazuril, has been shown in an animal model to prevent infections by organisms closely related to the intracellular parasite Cryptosporidium. Reliable data are needed to show the effectiveness of letrazuril in treating AIDS-related cryptosporidial diarrhea.
Condition | Intervention | Phase |
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Cryptosporidiosis HIV Infections |
Drug: Letrazuril |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Blinded, Placebo-Controlled, Single-Dose Pharmacokinetics and Dose Escalation, Efficacy, and Safety Study of Letrazuril for AIDS-Related Cryptosporidial Diarrhea |
Estimated Enrollment: | 32 |
Letrazuril, the p-fluor analog of diclazuril, has been shown in an animal model to prevent infections by organisms closely related to the intracellular parasite Cryptosporidium. Reliable data are needed to show the effectiveness of letrazuril in treating AIDS-related cryptosporidial diarrhea.
Four groups of eight patients receive escalating doses of oral letrazuril (or placebo). In each group, six patients are randomized to receive letrazuril and two patients receive matching placebo. In the pharmacokinetics determination phase of the study, patients receive a single dose of letrazuril or placebo following a meal. Following a 72-hour blood collection, patients enter the blinded, treatment phase of the study and receive letrazuril or placebo as a single dose daily, after a meal, for 3 weeks. Patients with persistent Cryptosporidium oocysts in their stools at the end of the blinded treatment phase may continue with open-label treatment of letrazuril at the same dose for 4 weeks; the dose may subsequently be escalated every 4 weeks, to a maximum, if oocysts persist. Patients who have Cryptosporidium oocysts eradicated from their stools will discontinue treatment and be followed for 3 months. All patients undergo clinical follow-up at 3 and 6 months.
Ages Eligible for Study: | 13 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must have:
Prior Medication:
Allowed:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Prior Medication:
Excluded:
United States, California | |
USC School of Medicine | |
Los Angeles, California, United States, 90033 | |
United States, New York | |
Cornell Univ Med Ctr | |
New York, New York, United States, 10021 | |
Saint Luke's - Roosevelt Hosp Ctr | |
New York, New York, United States, 10025 | |
Dr Douglas Dieterich | |
New York, New York, United States, 10016 |
Study Chair: | Moskovitz BL |
Study ID Numbers: | ACTG 198, Protocol JRD 65731/1001 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00001018 |
Health Authority: | United States: Federal Government |
Cryptosporidiosis Diarrhea Acquired Immunodeficiency Syndrome Antiprotozoal Agents Triazines |
Protozoan Infections Sexually Transmitted Diseases, Viral Diarrhea Signs and Symptoms, Digestive Gastrointestinal Diseases Acquired Immunodeficiency Syndrome Intestinal Diseases Immunologic Deficiency Syndromes Virus Diseases |
Signs and Symptoms Cryptosporidiosis Digestive System Diseases HIV Infections Sexually Transmitted Diseases Parasitic Diseases Intestinal Diseases, Parasitic Retroviridae Infections |
RNA Virus Infections Slow Virus Diseases Immune System Diseases Coccidiosis |
Lentivirus Infections Parasitic Diseases, Animal Protozoan Infections, Animal Infection |