Short Course of Miltefosine and Liposomal Amphotericin B for Kala-azar

NCT00371995 | Completed Phase 2

• 1 other identifier: LEI PDE 06 03
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

Brief Summary

Miltefosine and liposomal amphotericin B (AmBisome) are approved drugs for visceral leishmaniasis. In this study both drugs will be given in a sequential manner. AmBisome will be given on day 1, followed by Miltefosine for 14 days. Final Cure will be evaluated at six months.

Conditions

Visceral Leishmaniasis

Keywords

Visceral leishmaniasis; kala-azar; miltefosine; AmBisome

Outcome Measures

Primary Outcomes (1)

• Final Cure six months after the end of treatment

  1 year

Study Arms (1)

1

EXPERIMENTAL

Liposomal amphotericin B administered intravenously as single dose on day 1, Dosage: 5 mg/kg. Miltefosine administered orally (50 mg capsules) for 14 days (on days 2-15)

Drug: Liposomal amphotericin B and Miltefosine

Interventions

Liposomal amphotericin B and Miltefosine DRUG

Liposomal amphotericin B administered intravenously as single dose on day 1, Dosage: 5 mg/kg. Miltefosine administered orally (50 mg capsules) for 14 days (on days 2-15)

Also known as: AmBisome and Impavido

1

Eligibility Criteria

• Age: 2 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female age between 2 and 65 years (inclusive)
• Parasites visualized on splenic aspiration
• Signs and symptoms compatible with visceral leishmaniasis (e.g. fever, splenomegaly, anaemia, weight loss, leucopenia, thrombocytopenia)
• Confirmed diagnosis of VL by visualization of parasites on splenic/bone marrow aspirate
• Fever for at least 2 weeks
• Written informed consent from the patient/or from parent or guardian if under 18 years old

You may not qualify if:

• Hemoglobin \< 6 g/dl
• White blood cell count \< 1000/mm3
• Platelets \<50,000
• Prothrombin time \> 5 sec above control
• ASAT \> 3 times the upper limit of normal
• Serum creatinine or BUN \> 1.5 times the upper limit of normal
• Malaria
• Tuberculosis
• HIV positive serology
• Lactation, pregnancy
• Refusing contraception method during treatment period plus 3 months
• Any medical condition(s) that upon judgment of physician may affect the safety of the patient when treated with study drugs
• Any concomitant drug that is nephrotoxic

Sponsors & Collaborators

• Banaras Hindu University: lead
• Rajendra Memorial Research Institute of Medical Sciences: collaborator

Study Sites (2)

Kala-azar Medical Research Center

Muzaffarpur, Bihar, 842001, India

Location

Rajendra Memorial Research Institute of Medical Sciences

Patna, Bihar, India

Location

Related Publications (1)

• Sundar S, Sinha PK, Verma DK, Kumar N, Alam S, Pandey K, Kumari P, Ravidas V, Chakravarty J, Verma N, Berman J, Ghalib H, Arana B. Ambisome plus miltefosine for Indian patients with kala-azar. Trans R Soc Trop Med Hyg. 2011 Feb;105(2):115-7. doi: 10.1016/j.trstmh.2010.10.008. Epub 2010 Dec 3.

  PMID: 21129762 RESULT

MeSH Terms

Conditions

Leishmaniasis, Visceral

Interventions

liposomal amphotericin B; miltefosine

Condition Hierarchy (Ancestors)

Leishmaniasis; Euglenozoa Infections; Protozoan Infections; Parasitic Diseases; Infections; Vector Borne Diseases

Study Officials

• Shyam Sundar, MD

  Banaras Hindu University

  PRINCIPAL INVESTIGATOR

• Prabhat K Sinha, MD

  Rajendra Memorial Research Institute of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 5, 2006
• First Posted: September 6, 2006
• Study Start: October 1, 2007
• Primary Completion: August 1, 2009
• Study Completion: February 1, 2010
• Last Updated: June 22, 2011

Record last verified: 2008-09

Locations

IN (2)