Combination Chemotherapy for the Treatment of Indian Kala-Azar

Visceral Leishmaniasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00370825
• Other study ID #: KAMRC0601
• Status: Completed
• Phase: Phase 2
• First received: August 31, 2006
• Last updated: September 11, 2008
• Start date: September 2006

Study information

• Verified date: September 2008
• Source: Banaras Hindu University
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Gender: Both
• Age group: 12 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leishmaniasis
• Leishmaniasis, Visceral
• Visceral Leishmaniasis

Intervention

Drug:
• Combination therapy with AmBisome and miltefosine

Locations

Country	Name	City	State
India	Kala-azar Medical Research Center	Muzaffarpur	Bihar

Sponsors (1)

Lead Sponsor	Collaborator
Banaras Hindu University

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absence of clinical kala-azar at six month follow up