Combination Chemotherapy for the Treatment of Indian Kala-Azar

Combination Chemotherapy for the Treatment of Indian Visceral Leishmaniasis: Miltefosine Plus Liposomal Amphotericin B - Dose and Duration Ranging Study

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00370825

Enrollment

200

Registered

2006-09-01

Start date

2006-09-30

Completion date

Unknown

Last updated

2008-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Visceral Leishmaniasis

Keywords

Visceral leishmaniasis, miltefosine, AmBisome, Combination

Brief summary

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

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.

Interventions

DRUGCombination therapy with AmBisome and miltefosine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

12 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
Absence of clinical kala-azar at six month follow up	—

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 4, 2026