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Sponsors and Collaborators: |
AB Foundation AEterna Zentaris |
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Information provided by: | AB Foundation |
ClinicalTrials.gov Identifier: | NCT00378495 |
Miltefosine will be administered to Brazilian patients with kala azar
Condition | Intervention | Phase |
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Kala Azar |
Drug: Miltefosine: initially 2.5 mg/kg/day for 28 days |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Estimated Enrollment: | 80 |
Study Start Date: | April 2005 |
Estimated Study Completion Date: | October 2007 |
Miltefosine will be administered to Brazilian patients with kala azar. Both pediatric and adult patients will be studied. Patients will be followed for 6 months.
Ages Eligible for Study: | 2 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Newly diagnosed (untreated) visceral leishmaniasis with symptomatic disease and visualization of amastigotes in tissue samples or a positive culture.
Exclusion Criteria:
Exclusion criteria
Safety concerns:
Lack of suitability for the trial:
Administrative reasons:
Contact: Reynaldo Dietze | 55 27 - 2122-7204 |
Brazil | |
Universidade Estadual de Montes Claros | Recruiting |
Montes Claros, Brazil | |
Contact: Reynaldo Dietze | |
Principal Investigator: Reynaldo Dietze |
Principal Investigator: | Reynaldo Dietze | Núcleo de Doenças Infecciosas - UFES |
Study ID Numbers: | D-18506-Z019 |
Study First Received: | September 18, 2006 |
Last Updated: | September 18, 2006 |
ClinicalTrials.gov Identifier: | NCT00378495 History of Changes |
Health Authority: | Brazil: National Committee of Ethics in Research |
miltefosine kala azar Brazil |
Leishmaniasis Protozoan Infections Skin Diseases, Infectious Skin Diseases Clotrimazole Miconazole |
Antifungal Agents Miltefosine Tioconazole Parasitic Diseases Leishmaniasis, Visceral |
Leishmaniasis Anti-Infective Agents Protozoan Infections Antiprotozoal Agents Skin Diseases, Parasitic Skin Diseases Antineoplastic Agents Miltefosine Mastigophora Infections |
Pharmacologic Actions Antiparasitic Agents Skin Diseases, Infectious Antifungal Agents Therapeutic Uses Leishmaniasis, Visceral Sarcomastigophora Infections Parasitic Diseases |