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Single Infusion of Liposomal Amphotericin B in Indian Visceral Leishmaniasis

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ClinicalTrials.gov Identifier: NCT00628719
Recruitment Status : Completed
First Posted : March 5, 2008
Last Update Posted : April 3, 2009
Sponsor:
Information provided by:
Banaras Hindu University

Brief 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.

Condition or disease Intervention/treatment Phase
Visceral Leishmaniasis Drug: Liposomal Amphotericin B Drug: amphotericin B deoxycholate Phase 3

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : February 2008
Actual Primary Completion Date : August 2008
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leishmaniasis
U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Final cure rate at six months after the end of treatment [ Time Frame: One year ]

Secondary Outcome Measures :
  1. Initial cure after the end of treatment [ Time Frame: six months ]


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Ages Eligible for Study:   2 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: March 5, 2008    Key Record Dates
Last Update Posted: April 3, 2009
Last Verified: April 2009

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
Anti-Bacterial Agents
Antifungal Agents
Cholagogues and Choleretics
Gastrointestinal Agents