Combination Chemotherapy for the Treatment of Indian Kala-Azar

This study has been completed.
Sponsor:
Information provided by:
Banaras Hindu University
ClinicalTrials.gov Identifier:
NCT00370825
First received: August 31, 2006
Last updated: September 11, 2008
Last verified: September 2008
  Purpose

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


Condition Intervention Phase
Visceral Leishmaniasis
Drug: Combination therapy with AmBisome and miltefosine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Combination Chemotherapy for the Treatment of Indian Visceral Leishmaniasis: Miltefosine Plus Liposomal Amphotericin B - Dose and Duration Ranging Study

Resource links provided by NLM:


Further study details as provided by Banaras Hindu University:

Primary Outcome Measures:
  • Absence of clinical kala-azar at six month follow up

Estimated Enrollment: 200
Study Start Date: September 2006
Detailed Description:

In this sequential design four arm study one arm is a reference arm but the three arms will consist an of initial dose of liposomal amphotericin B on first day followed by miltefosine. Both the drugs will be used in different doses. Reference arm will consist only a single dose of amBisome at 5 mg/kg. After the end of treatment, the post treatment assessment will be done on day 16 (initial cure) and six months (final cure). Safety parameters will be evaluated on day 0, 8 and 16. An arm with an efficacy of less than 75% will be closed. There will be periodical assessment of study results after completion of 5 patients in each arm.

  Eligibility

Ages Eligible for Study:   12 Years to 65 Years
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00370825

Locations
India
Kala-azar Medical Research Center
Muzaffarpur, Bihar, India, 842001
Sponsors and Collaborators
Banaras Hindu University
Investigators
Principal Investigator: 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):
ClinicalTrials.gov Identifier: NCT00370825     History of Changes
Other Study ID Numbers: KAMRC0601
Study First Received: August 31, 2006
Last Updated: September 11, 2008
Health Authority: India: Ministry of Health

Keywords provided by Banaras Hindu University:
Visceral leishmaniasis
miltefosine
AmBisome
Combination

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
Miltefosine
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Bacterial Agents
Antineoplastic Agents

ClinicalTrials.gov processed this record on April 14, 2014