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Sponsors and Collaborators: |
Drugs for Neglected Diseases Addis Ababa University |
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Information provided by: | Drugs for Neglected Diseases |
ClinicalTrials.gov Identifier: | NCT00832208 |
This is a phase II/III open, comparative dose trial to find the lowest single dose of AmBisome for the treatment of primary, symptomatic visceral leishmaniasis(VL), in HIV negative patients. In this trial, the minimum effective dose will be determined in a sequential step, dose escalation design, which minimises the number of patients exposed to low, potentially inadequate doses and provides contemporaneous comparative data against the manufacturer's recommended dose schedule in this indication.
Condition | Intervention | Phase |
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Visceral Leishmaniasis |
Drug: Liposomal amphotericin B (Ambisome) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study |
Official Title: | Open-Label, Sequential Step, Safety and Efficacy Study to Determine the Optimal Single Dose of Ambisome for Patients With Visceral Leishmaniasis |
Estimated Enrollment: | 240 |
Study Start Date: | March 2009 |
Estimated Study Completion Date: | June 2011 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Ambisome control:: Active Comparator
Ambisome, Total dose 21.0 mg given as 7 x 3mg on days 1,2,3,4,5, and 14 and 21
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Drug: Liposomal amphotericin B (Ambisome)
21.0 mg/kg total dose. Given iv as 3mg/kg/day on days 1,2,3,4,5, and 14 and 21
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Ambisome test: Experimental
Single dose Ambisome in sequence(7.5 / 10.0/ 12.5 / 15.0mg)
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Drug: Liposomal amphotericin B (Ambisome)
liposomal amphotericin b given intravenously as single dose at 7.5 mg/kg increasing to 10, 12.5 and 15.0mg/kg depending on results of interim analyses.
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Ages Eligible for Study: | 4 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Asrat Hailu | hailu_a2004@yahoo.com |
Ethiopia | |
Arba Minch LRTC | |
Arba Minch, Ethiopia | |
Gondar | |
Gondar, Ethiopia |
Principal Investigator: | Sisay Yifru, MD | Gondar University |
Responsible Party: | Drugs for Neglected Disease Initiative ( Sally Ellis ) |
Study ID Numbers: | AMBI 0106 |
Study First Received: | January 29, 2009 |
Last Updated: | January 29, 2009 |
ClinicalTrials.gov Identifier: | NCT00832208 History of Changes |
Health Authority: | Ethiopia: Drug Administration and Control Authority |
Leishmaniasis Abelcet Protozoan Infections Amphotericin B Skin Diseases Clotrimazole Miconazole |
Tioconazole Liposomal amphotericin B Anti-Bacterial Agents Skin Diseases, Infectious Antifungal Agents Leishmaniasis, Visceral Parasitic Diseases |
Leishmaniasis Abelcet Anti-Infective Agents Protozoan Infections Amphotericin B Antiprotozoal Agents Skin Diseases, Parasitic Skin Diseases Mastigophora Infections Liposomal amphotericin B Pharmacologic Actions |
Anti-Bacterial Agents Antiparasitic Agents Skin Diseases, Infectious Antifungal Agents Therapeutic Uses Antibiotics, Antifungal Leishmaniasis, Visceral Sarcomastigophora Infections Parasitic Diseases Amebicides |