Visceral Leishmaniasis
Conditions
Keywords
Visceral Leishmaniasis, Amphotericin B, Fat emulsion
Brief summary
The purpose of this study is: 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
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. 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)
Interventions
DRUGAmphotericin 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
DRUGAmphotericin 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
DRUGAmphotericin 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
Sponsors
Banaras Hindu University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female subjects between 18 years and 65 years of age (both inclusive). 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
1. Subjects with past history of treatment with Amphotericin B for Kala-azar. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical and parasitological cure at end of treatment and final cure (no relapse) at six months, no hematological, hepatic or renal toxicity | one year |
Countries
India
Outcome results
None listed