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Single Infusion of Liposomal Amphotericin B in Indian Visceral Leishmaniasis

Information source: Banaras Hindu University
ClinicalTrials.gov processed this data on August 20, 2015
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: Completed

Sponsored by: Banaras Hindu University

Official(s) and/or principal investigator(s):
Shyam Sundar, MD, Study Director, Affiliation: Banaras Hindu University

Summary

The purpose of this trial is to evaluate the efficacy of single dose amphotericin B in the treatment of Visceral Leishmaniasis (VL) in India.

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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

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 > 3. 5g/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

Kala-azar Medical Research Center, Rambag Road, Muzaffarpur 842001, India
Additional Information

Starting date: February 2008
Last updated: April 2, 2009

Page last updated: August 20, 2015

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