Combination Chemotherapy for the Treatment of Indian Kala-Azar

Phase 2

Completed

• Conditions: Visceral Leishmaniasis

• Registration Number: NCT00370825
• Lead Sponsor: Banaras Hindu University

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.

Study Timeline

• Study First Submitted: 2006-08-31
• Study First Submitted QC: 2006-08-31
• Study Start: 2006-09
• Study First Posted: 2006-09-01
• Status Verified: 2008-09
• Last Update Submitted: 2008-09-11
• Last Update Posted: 2008-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Absence of clinical kala-azar at six month follow up

Trial Locations

Locations (1)

Kala-azar Medical Research Center; 🇮🇳 Muzaffarpur, Bihar, India