Health Condition 1: null- Visceral Leishmaniasis (Kala-Azar)
Conditions
Interventions
Intervention1: Liposomal Amphotericin B: Single dose of 10 mg/kg
Intervention2: Liposomal Amphotericin B: Single dose of 15 mg/kg
Control Intervention1: None: None
Sponsors
Lifecare Innovations Pvt Ltd
GVK Biosciences P Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Males and females between 12 and 60 years of age (both inclusive) • Fever ( >99oF) with one or more of the following: • Weight loss and/or decrease in appetite • Enlarged spleen • Anaemia (5 • Diagnosis of visceral leishmaniasis confirmed with bone marrow or splenic aspirate • Clinically stable and willing to attend the out-patient department for followup as necessary • Written informed consent from the patient or from parent or guardian if under 18 years old
Exclusion criteria
Exclusion criteria: Any past history of treatment of VL during last 45 days • History of Hepatitis B, C or known HIV-positive individual • Active tuberculosis or on anti-tubercular drugs • Patients using other antileishmanial drugs • Those who have known hypersensitivity/allergy to the study drugs or their constituents. • Patients who have associated disease known to alter liver/kidney functions • Pregnant or lactating women • Women of child bearing age refusing/cannot assure use of contraceptive method during treatment period plus 3 months thereafter • Other serious illness or medical condition that in the opinion of the investigator would interfere with the patientâ??s ability to receive any of the study treatments or comply with study procedures or may affect the safety of the patient when treated with study drugs • Patients who have received any investigational drug within the last 6 months • Serum creatinine or BUN 1.5 times the upper limit of normal • Any concomitant drug that is nephrotoxic • Signs/symptoms indicative of severe VL • Platelet count 40, 000 per cubic millimeter Bilirubin 2mg/deciliter • Prothrombin time of more than 5 seconds above the control levels
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate safety of single dose of 10mg/kg and 15mg/kg FUNGISOME TM i.v. for treatment of visceral leishmaniasisTimepoint: 30 days post treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the initial cure at Day 30 post treatment with single dose of 10mg/kg and 15mg/kg FUNGISOME TM i.v. for treatment of visceral leishmaniasisTimepoint: Day 30 | — |
Countries
India
Contacts
Public ContactDr Jitendra N Verma
Lifecare Innovations Pvt. Ltd.
Outcome results
None listed