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Combination Chemotherapy for the Treatment of Indian Kala-Azar

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00370825
First Posted: September 1, 2006
Last Update Posted: September 12, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Banaras Hindu University
  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
Intervention Model: Parallel Assignment
Masking: None (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

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00370825     History of Changes
Other Study ID Numbers: KAMRC0601
First Submitted: August 31, 2006
First Posted: September 1, 2006
Last Update Posted: September 12, 2008
Last Verified: September 2008

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
Liposomal amphotericin B
Amphotericin B
Antifungal Agents
Anti-Infective Agents
Antineoplastic Agents
Antiprotozoal Agents
Antiparasitic Agents
Amebicides
Anti-Bacterial Agents