A Phase II Study To Assess Safety and Efficacy Of Short-Course Regimens Of Amphotericin B Emulsion In Kala-Azar
NCT ID: NCT00497601
Last Updated: 2008-09-12
Study Results
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Basic Information
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COMPLETED
PHASE2
60 participants
INTERVENTIONAL
2007-02-28
2008-07-31
Brief Summary
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1. To evaluate the Safety and Efficacy of four different short-course regimens of Amphotericin B emulsion in treatment of Kala-azar (visceral leishmaniasis) subjects who are either treatment naive or treatment resistant to other antileishmanial drugs except amphotericin B containing preparations.
2. To assess the safety and efficacy of single-bolus infusion of Amphotericin B emulsion in treatment of Kala-azar.
Detailed Description
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2. To assess the safety and efficacy of single-bolus infusion of Amphotericin B emulsion in treatment of Kala-azar.
Subjects will be administered the study drug in either of the following four dose levels in an ascending manner, starting with the first dosage regimen:
* 7.5 mg/kg on day 1 and day3 (Regimen 1)
* 10 mg/kg on day 1, followed by 5 mg/kg on day 3 (Regimen 2)
* 12.5 mg/kg on day 1, followed by 2.5 mg/kg on day 3 (Regimen 3)
* Single-bolus infusion of 15 mg/kg over 2-4 hours on day 1 (Regimen 4)
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A
Amphotericin B in fat emulsion (Amphomul) 7.5 mg/kg on day 1 and 3
Amphotericin B fat emulsion in visceral leishmaniasis
Amphotericin B in fat emulsion (Amphomul) 7.5 mg/kg on day 1 \& 3 in group A Amphotericin B in fat emulsion (Amphomul) 10 \& 5 mg/kg on day 1 \& 3 in group B Amphotericin B in fat emulsion (Amphomul) 12.5 \& 2.5 mg/kg on day 1 \& 3 in group C Amphotericin B in fat emulsion (Amphomul) 15 mg/kg on day 1 in group D
Amphotericin B fat emulsion
Starting with 7.5 mg/kg on day 1 and 3, 10 and 5 mg/kg on day 1 and 3, 12.5 and 2.5 mg/kg on day 1 and 3 and finally 15 mg/kg on day 1
Amphotericin B in fat emulsion
Starting with 7.5 mg/kg on day 1 and 3, 10 and 5 mg/kg on day 1 and 3, 12.5 and 2.5 mg/kg on day 1 and 3 and finally 15 mg/kg on day 1
B
Amphotericin B in fat emulsion (Amphomul) 10 mg/kg on day 1 and 5 mg/kg on day 3
Amphotericin B fat emulsion in visceral leishmaniasis
Amphotericin B in fat emulsion (Amphomul) 7.5 mg/kg on day 1 \& 3 in group A Amphotericin B in fat emulsion (Amphomul) 10 \& 5 mg/kg on day 1 \& 3 in group B Amphotericin B in fat emulsion (Amphomul) 12.5 \& 2.5 mg/kg on day 1 \& 3 in group C Amphotericin B in fat emulsion (Amphomul) 15 mg/kg on day 1 in group D
Amphotericin B fat emulsion
Starting with 7.5 mg/kg on day 1 and 3, 10 and 5 mg/kg on day 1 and 3, 12.5 and 2.5 mg/kg on day 1 and 3 and finally 15 mg/kg on day 1
Amphotericin B in fat emulsion
Starting with 7.5 mg/kg on day 1 and 3, 10 and 5 mg/kg on day 1 and 3, 12.5 and 2.5 mg/kg on day 1 and 3 and finally 15 mg/kg on day 1
C
Amphotericin B in fat emulsion (Amphomul) 12.5 mg/kg on day 1 and 2.5 mg/kg on day 3
Amphotericin B fat emulsion in visceral leishmaniasis
Amphotericin B in fat emulsion (Amphomul) 7.5 mg/kg on day 1 \& 3 in group A Amphotericin B in fat emulsion (Amphomul) 10 \& 5 mg/kg on day 1 \& 3 in group B Amphotericin B in fat emulsion (Amphomul) 12.5 \& 2.5 mg/kg on day 1 \& 3 in group C Amphotericin B in fat emulsion (Amphomul) 15 mg/kg on day 1 in group D
Amphotericin B fat emulsion
Starting with 7.5 mg/kg on day 1 and 3, 10 and 5 mg/kg on day 1 and 3, 12.5 and 2.5 mg/kg on day 1 and 3 and finally 15 mg/kg on day 1
Amphotericin B in fat emulsion
Starting with 7.5 mg/kg on day 1 and 3, 10 and 5 mg/kg on day 1 and 3, 12.5 and 2.5 mg/kg on day 1 and 3 and finally 15 mg/kg on day 1
D
Amphotericin B in fat emulsion (Amphomul) 15 mg/kg in a single dose administration on day 1
Amphotericin B fat emulsion in visceral leishmaniasis
Amphotericin B in fat emulsion (Amphomul) 7.5 mg/kg on day 1 \& 3 in group A Amphotericin B in fat emulsion (Amphomul) 10 \& 5 mg/kg on day 1 \& 3 in group B Amphotericin B in fat emulsion (Amphomul) 12.5 \& 2.5 mg/kg on day 1 \& 3 in group C Amphotericin B in fat emulsion (Amphomul) 15 mg/kg on day 1 in group D
Amphotericin B fat emulsion
Starting with 7.5 mg/kg on day 1 and 3, 10 and 5 mg/kg on day 1 and 3, 12.5 and 2.5 mg/kg on day 1 and 3 and finally 15 mg/kg on day 1
Amphotericin B in fat emulsion
Starting with 7.5 mg/kg on day 1 and 3, 10 and 5 mg/kg on day 1 and 3, 12.5 and 2.5 mg/kg on day 1 and 3 and finally 15 mg/kg on day 1
Interventions
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Amphotericin B fat emulsion in visceral leishmaniasis
Amphotericin B in fat emulsion (Amphomul) 7.5 mg/kg on day 1 \& 3 in group A Amphotericin B in fat emulsion (Amphomul) 10 \& 5 mg/kg on day 1 \& 3 in group B Amphotericin B in fat emulsion (Amphomul) 12.5 \& 2.5 mg/kg on day 1 \& 3 in group C Amphotericin B in fat emulsion (Amphomul) 15 mg/kg on day 1 in group D
Amphotericin B fat emulsion
Starting with 7.5 mg/kg on day 1 and 3, 10 and 5 mg/kg on day 1 and 3, 12.5 and 2.5 mg/kg on day 1 and 3 and finally 15 mg/kg on day 1
Amphotericin B in fat emulsion
Starting with 7.5 mg/kg on day 1 and 3, 10 and 5 mg/kg on day 1 and 3, 12.5 and 2.5 mg/kg on day 1 and 3 and finally 15 mg/kg on day 1
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Subject/subject's legally acceptable representative is willing and able to give written informed consent to participate in the study.
3. Treatment naive subjects having symptoms and/or signs of visceral leishmaniasis with parasitological confirmation of Kala-azar (by splenic or bone marrow aspirate smear examination).
If subjects are previously treated with other antileishmanial drugs except amphotericin B containing preparations, they will be enrolled in the study only after clinical and parasitological evidence that the disease is unresponsive to adequate treatment with other drugs, and after an appropriate wash out period
Exclusion Criteria
2. Subjects positive for HIV infection.
3. Concomitant life threatening or serious disease.
4. Concurrent malaria (malarial parasite test to be negative prior to study treatment administration), tuberculosis or bacterial pneumonia.
5. Haemoglobin \< 6 gm/dl, total leukocyte count \< 1,500/cmm, platelet count \< 50,000/cmm
6. Abnormal liver and renal functions (BUN and serum creatinine \> 1.5 times upper limit of normal (ULN), AST/ALT \> 2.5 times ULN, and bilirubin \> 1.5 times ULN).
7. Pregnant or nursing women.
8. Known hypersensitivity to Amphotericin B or inactive ingredients of study drug formulation.
9. Subjects receiving any of the medications prohibited by the study protocol.
10. Evidence of significant haematological, cardiac, hepatic, renal, respiratory, neurological or metabolic disease or any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
11. Simultaneous participation in another trial or received any investigational product \< 30 days prior to enrolment.
18 Years
65 Years
ALL
No
Sponsors
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Banaras Hindu University
OTHER
Principal Investigators
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Shyam Sundar
Role: PRINCIPAL_INVESTIGATOR
Banaras Hindu University
Locations
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Kala-azar Medical Research Center
Muzaffarpur, Bihar, India
Countries
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Other Identifiers
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BSV-AMBE II-KA-706
Identifier Type: -
Identifier Source: org_study_id