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Sponsored by: |
Banaras Hindu University |
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Information provided by: | Banaras Hindu University |
ClinicalTrials.gov Identifier: | NCT00628719 |
The purpose of this trial is to evaluate the efficacy of single dose amphotericin B in the treatment of VL in India.
Condition | Intervention | Phase |
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Visceral Leishmaniasis |
Drug: Liposomal Amphotericin B Drug: amphotericin B deoxycholate |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase III Randomized, Controlled, Clinical Trial to Assess the Safety and Efficacy of Single Infusion of Liposomal Amphotericin B in Patients With Visceral Leishmaniasis |
Estimated Enrollment: | 400 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | February 2009 |
Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
a single dose of 10 mg/kg of liposomal amphotericin B
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Drug: Liposomal Amphotericin B
a single dose of 10 mg/kg of liposomal amphotericin B
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2: Active Comparator
amphotericin B as a 1x test dose and then at a dose of 1 mg/kg/every other day for a total of 15 doses over 30 days.
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Drug: amphotericin B deoxycholate
amphotericin B as a 1x test dose and then at a dose of 1 mg/kg/every other day for a total of 15 doses over 30 days.
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The purpose of this trial is to evaluate the efficacy of single dose amphotericin B in the treatment of VL in India.
Primary objective: Comparison of the efficacy of single dose of 10 mg/kg of liposomal amphotericin B to amphotericin B deoxycholate with regards to final cure rates
Secondary objective:. Comparison of the safety of single dose of 10 mg/kg of liposomal amphotericin B to amphotericin B deoxycholate when administered in the proposed dosage regimens.
Ages Eligible for Study: | 2 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Banaras Hindu University ( Professor Shyam Sundar ) |
Study ID Numbers: | AA KAMRC |
Study First Received: | February 20, 2008 |
Last Updated: | September 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00628719 |
Health Authority: | India: Institutional Review Board |
Visceral leishmaniasis India Liposomal Amphotericin B Amphotericin B deoxycholate |
Leishmaniasis Abelcet Protozoan Infections Amphotericin B Skin Diseases Clotrimazole Miconazole |
Tioconazole Liposomal amphotericin B Skin Diseases, Infectious Deoxycholic Acid Leishmaniasis, Visceral Parasitic Diseases Amphotericin B-deoxycholate |
Anti-Infective Agents Antiprotozoal Agents Skin Diseases, Parasitic Gastrointestinal Agents Mastigophora Infections Pharmacologic Actions Anti-Bacterial Agents |
Antiparasitic Agents Therapeutic Uses Antifungal Agents Cholagogues and Choleretics Antibiotics, Antifungal Sarcomastigophora Infections Amebicides |