Combination Chemotherapy for the Treatment of Indian Kala-Azar
Tracking Information | |||||
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First Received Date ICMJE | August 31, 2006 | ||||
Last Updated Date | September 11, 2008 | ||||
Start Date ICMJE | September 2006 | ||||
Primary Completion Date | |||||
Current Primary Outcome Measures ICMJE |
Absence of clinical kala-azar at six month follow up | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT00370825 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE | |||||
Original Secondary Outcome Measures ICMJE | |||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Combination Chemotherapy for the Treatment of Indian Kala-Azar | ||||
Official Title ICMJE | Combination Chemotherapy for the Treatment of Indian Visceral Leishmaniasis: Miltefosine Plus Liposomal Amphotericin B - Dose and Duration Ranging Study | ||||
Brief Summary | The investigators are using a sequential design to combine miltefosine and AmBisome in different doses. |
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Detailed Description | In this sequential design four arm study one arm is a reference arm but the three arms will consist an of initial dose of liposomal amphotericin B on first day followed by miltefosine. Both the drugs will be used in different doses. Reference arm will consist only a single dose of amBisome at 5 mg/kg. After the end of treatment, the post treatment assessment will be done on day 16 (initial cure) and six months (final cure). Safety parameters will be evaluated on day 0, 8 and 16. An arm with an efficacy of less than 75% will be closed. There will be periodical assessment of study results after completion of 5 patients in each arm. |
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 2 | ||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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Condition ICMJE | Visceral Leishmaniasis | ||||
Intervention ICMJE | Drug: Combination therapy with AmBisome and miltefosine | ||||
Study Arm (s) | |||||
Publications * | Sundar S, Rai M, Chakravarty J, Agarwal D, Agrawal N, Vaillant M, Olliaro P, Murray HW. New treatment approach in Indian visceral leishmaniasis: single-dose liposomal amphotericin B followed by short-course oral miltefosine. Clin Infect Dis. 2008 Oct 15;47(8):1000-6. | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Enrollment ICMJE | 200 | ||||
Completion Date | |||||
Primary Completion Date | |||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 12 Years to 65 Years | ||||
Accepts Healthy Volunteers | |||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | India | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00370825 | ||||
Other Study ID Numbers ICMJE | KAMRC0601 | ||||
Has Data Monitoring Committee | |||||
Responsible Party | |||||
Study Sponsor ICMJE | Banaras Hindu University | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Banaras Hindu University | ||||
Verification Date | September 2008 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |