Single Infusion of Liposomal Amphotericin B in Indian Visceral Leishmaniasis

This study has been completed.
Sponsor:
Information provided by:
Banaras Hindu University
ClinicalTrials.gov Identifier:
NCT00628719
First received: February 20, 2008
Last updated: April 2, 2009
Last verified: April 2009
  Purpose

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


Condition Intervention Phase
Visceral Leishmaniasis
Drug: Liposomal Amphotericin B
Drug: amphotericin B deoxycholate
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Banaras Hindu University:

Primary Outcome Measures:
  • Final cure rate at six months after the end of treatment [ Time Frame: One year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Initial cure after the end of treatment [ Time Frame: six months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 400
Study Start Date: February 2008
Study Completion Date: March 2009
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
a single dose of 10 mg/kg of liposomal amphotericin B
Drug: Liposomal Amphotericin B
a single dose of 10 mg/kg of liposomal amphotericin B
Other Name: AmBisome
Active Comparator: 2
amphotericin B as a 1x test dose and then at a dose of 1 mg/kg/every other day for a total of 15 doses over 30 days.
Drug: amphotericin B deoxycholate
amphotericin B as a 1x test dose and then at a dose of 1 mg/kg/every other day for a total of 15 doses over 30 days.
Other Name: Amphotericin B deoxycholate

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

Ages Eligible for Study:   2 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00628719

Locations
India
Kala-azar Medical Research Center, Rambag Road
Muzaffarpur, India, 842001
Sponsors and Collaborators
Banaras Hindu University
Investigators
Study Director: Shyam Sundar, MD Banaras Hindu University
  More Information

No publications provided by Banaras Hindu University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Professor Shyam Sundar, Banaras Hindu University
ClinicalTrials.gov Identifier: NCT00628719     History of Changes
Other Study ID Numbers: AA KAMRC
Study First Received: February 20, 2008
Last Updated: April 2, 2009
Health Authority: India: Institutional Review Board

Keywords provided by Banaras Hindu University:
Visceral leishmaniasis
India
Liposomal Amphotericin B
Amphotericin B deoxycholate

Additional relevant MeSH terms:
Leishmaniasis
Leishmaniasis, Visceral
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases
Amphotericin B
Liposomal amphotericin B
Amphotericin B, deoxycholate drug combination
Deoxycholic Acid
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Bacterial Agents
Cholagogues and Choleretics
Gastrointestinal Agents

ClinicalTrials.gov processed this record on April 17, 2014