Clinical trial NCT00628719: Single Infusion of Liposomal Amphotericin B in Indian Visceral Leishmaniasis
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Visceral Leishmaniasis
Keywords: Visceral leishmaniasis
India
Liposomal Amphotericin B
Amphotericin B deoxycholate
Lead sponsor: Banaras Hindu University
Sponsor class: OTHER
First posted: 2008-03-05
Enrollment: 400
Sex: ALL
Minimum age (years): 2
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: Final cure rate at six months after the end of treatment
timeFrame: One year
Secondary outcomes:
measure: Initial cure after the end of treatment
timeFrame: six months
Other outcomes:
Locations:
city: Muzaffarpur
country: India
facility: Kala-azar Medical Research Center, Rambag Road
Study officials:
affiliation: Banaras Hindu University
name: Shyam Sundar, MD
role: STUDY_DIRECTOR
References:
citation: Sundar S, Chakravarty J, Agarwal D, Rai M, Murray HW. Single-dose liposomal amphotericin B for visceral leishmaniasis in India. N Engl J Med. 2010 Feb 11;362(6):504-12. doi: 10.1056/NEJMoa0903627.