Combination Chemotherapy for the Treatment of Indian Kala-Azar
Information source: Banaras Hindu University
Information obtained from ClinicalTrials.gov on December 31, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Visceral Leishmaniasis
Intervention: Combination therapy with AmBisome and miltefosine (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Banaras Hindu University Official(s) and/or principal investigator(s):
Shyam Sundar, MD, Principal Investigator, Affiliation: Banaras Hindu University
Summary
We are using a sequential design to combine miltefosine and AmBisome in different doses.
Clinical Details
Official title: Combination Chemotherapy for the Treatment of Indian Visceral Leishmaniasis: Miltefosine Plus Liposomal Amphotericin B - Dose and Duration Ranging Study
Study design: Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Absence of clinical kala-azar at six month follow up
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
Minimum age: 12 Years.
Maximum age: 65 Years.
Gender(s): 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
Locations and Contacts
Kala-azar Medical Research Center, Muzaffarpur, Bihar 842001, India
Additional Information
Starting date: September 2006
Last updated: March 12, 2007
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