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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on September 16, 2014