Combination Chemotherapy for the Treatment of Indian Kala-Azar

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Visceral Leishmaniasis

Keywords

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Visceral leishmaniasis miltefosine AmBisome Combination

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Combination therapy with AmBisome and miltefosine

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

12 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Shyam Sundar, MD

Role: PRINCIPAL_INVESTIGATOR

Banaras Hindu University

Locations

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Kala-azar Medical Research Center

Muzaffarpur, Bihar, India

Site Status

Countries

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India

References

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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.

Reference Type DERIVED

PMID: 18781879 (View on PubMed)

Other Identifiers

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KAMRC0601

Identifier Type: -

Identifier Source: org_study_id