Single Infusion of Liposomal Amphotericin B in Indian Visceral Leishmaniasis
Information source: Banaras Hindu University
Information obtained from ClinicalTrials.gov on August 08, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Visceral Leishmaniasis
Intervention: Liposomal Amphotericin B (Drug); amphotericin B deoxycholate (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Banaras Hindu University Official(s) and/or principal investigator(s):
Shyam Sundar, MD, Study Director, Affiliation: Banaras Hindu University
Overall contact:
Shyam Sundar, Phone: 91-621-2287570, Email: drshyamsundar@hotmail.com
Summary
The purpose of this trial is to evaluate the efficacy of single dose amphotericin B in the
treatment of VL in India.
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Clinical Details
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
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: final cure rate at six months after the end of treatment
Secondary outcome: Initial cure after the end of treatment
Detailed description:
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.
Eligibility
Minimum age: 2 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Children and adults 2-65 years of age (inclusive) of either gender.
- Diagnosis of VL confirmed by spleen or bone marrow aspirate.
- Clinical signs and symptoms compatible with VL.
- Biochemical and haematological test values as follows:
- Haemoglobin > 4. 0g/100mL
- White blood cell count > 0. 75 x109/L
- Platelet count > 40 x 109/L
- AST, ALT and alkaline phosphatase < 5 times upper normal limit
- Prothrombin time < 4 seconds above control
- Serum creatinine levels - 1. 5 times upper normal limit
- Serum potassium levels within normal limits
- HIV negative.
Exclusion Criteria:
- A history of intercurrent or concurrent diseases (e. g. chronic alcohol consumption or
drug addiction; renal, hepatic, cardiovascular or CNS disease; diabetes; tuberculosis;
other infectious or major psychiatric diseases) that may introduce variables that
affect the outcome of the study.
- Any condition which the investigator thinks may prevent the patient from completing
the study therapy and subsequent follow-up.
- Proteinuria (> 2+).
- A history of allergy or hypersensitivity to amphotericin B
- Previous treatment for VL within two weeks of enrollment into the study.
- Prior treatment failures with amphotericin B.
Locations and Contacts
Shyam Sundar, Phone: 91-621-2287570, Email: drshyamsundar@hotmail.com
Kala-azar Medical Research Center, Rambag Road, Muzaffarpur 842001, India; Recruiting
Manish Kumar, MBBS
Shyam Sundar, MD, Principal Investigator
Additional Information
Starting date: February 2008
Ending date: February 2009
Last updated: February 25, 2008
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