NCT00370825

Brief Summary

The investigators are using a sequential design to combine miltefosine and AmBisome in different doses.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 1, 2006

Completed
Same day until next milestone

Study Start

First participant enrolled

September 1, 2006

Completed
Last Updated

September 12, 2008

Status Verified

September 1, 2008

First QC Date

August 31, 2006

Last Update Submit

September 11, 2008

Conditions

Visceral Leishmaniasis

Keywords

Visceral leishmaniasismiltefosineAmBisomeCombination

Outcome Measures

Primary Outcomes (1)

  • Absence of clinical kala-azar at six month follow up

Interventions

Combination therapy with AmBisome and miltefosineDRUG

Eligibility Criteria

Age12 Years - 65 Years
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of active VL with consistent signs and symptoms (e.g., fever, splenomegaly).
  • Confirmed diagnosis by bone-marrow or splenic aspirate smear showing characteristic amastigotes.
  • Male or female.
  • Ages 12 to 65 years.
  • Both newly diagnosed cases and patients who have received previous treatment (in the latter case a 2-week wash-out will be required before starting the study treatment).
  • WBC \> 1,000/mm3.
  • Hemoglobin ≥ 4 g/dL

You may not qualify if:

  • Pregnancy or breast-feeding.
  • HIV positive serology.
  • ASAT, ALAT, AP ≥ 3 times upper limit of normal range.
  • Bilirubin ≥ 2 times upper limit of normal range.
  • Prothrombin time ≥ 5 seconds above control.
  • Serum creatinine or BUN ≥ 1.5 times upper limit of normal range.
  • Any medical condition or situation that compromises compliance with study procedures.
  • HIV

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kala-azar Medical Research Center

Muzaffarpur, Bihar, 842001, India

Location

Related Publications (1)

  • Sundar S, Rai M, Chakravarty J, Agarwal D, Agrawal N, Vaillant M, Olliaro P, Murray HW. New treatment approach in Indian visceral leishmaniasis: single-dose liposomal amphotericin B followed by short-course oral miltefosine. Clin Infect Dis. 2008 Oct 15;47(8):1000-6. doi: 10.1086/591972.

    PMID: 18781879DERIVED

MeSH Terms

Conditions

Leishmaniasis, Visceral

Interventions

Combined Modality Therapyliposomal amphotericin Bmiltefosine

Condition Hierarchy (Ancestors)

LeishmaniasisEuglenozoa InfectionsProtozoan InfectionsParasitic DiseasesInfectionsVector Borne Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Shyam Sundar, MD

    Banaras Hindu University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 31, 2006

First Posted

September 1, 2006

Study Start

September 1, 2006

Last Updated

September 12, 2008

Record last verified: 2008-09

Locations

IN(1)