Phase III, Study of Three Short Course Combo (Ambisome®, Miltefosine, Paromomycin) Compared With AmBisome for the Treatment of VL in Bangladesh

• Register: ClinicalTrials.gov
• Last refreshed on: 1 February 2016
• Main ID: NCT01122771
• Date of registration: 11/05/2010
• Prospective Registration: No
• Primary sponsor: Drugs for Neglected Diseases
• Public title: Phase III, Study of Three Short Course Combo (Ambisome®, Miltefosine, Paromomycin) Compared With AmBisome for the Treatment of VL in Bangladesh
• Scientific title: A Phase III, Open Label, Randomised, Study of Three Short Course Combination Regimens (Ambisome®, Miltefosine, Paromomycin) Compared With AmBisome® Alone for the Treatment of Visceral Leishmaniasis (VL) in Bangladesh
• Date of first enrolment: May 2010
• Target sample size: 602
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01122771
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Bangladesh

Contacts

• Name: Ridwanur Rahman, MD
• Affiliation: Shaheed Surawardy Medical College

Key inclusion & exclusion criteria

Inclusion Criteria:

- VL proven by parasitological examination of splenic or bone marrow aspirate. Parasite
burden to be graded according to Chulay and Bryceson 1983 and subsequently adopted by
WHO. (Step 1 only)

- History of fever, for at least 2 weeks with one or more of the followings criteria:
Anaemia (5
- rk39 positive at baseline assessments

- willing and able to attend follow-up visits

- Male or Female age: 5-60 yrs

- Written informed consent from the patient or from patient's parent or guardian if the
patient is under 18 yrs, in addition written assent from patients of 11 - 17 yrs of
age. If the patient or parent/guardian are illiterate an impartial witness should be
present during the consenting procedure and should also sign.

Exclusion Criteria:

- Married women of child-bearing potential (defined as women who have achieved
menarche) who are not using an assured method of contraception or are unwilling to
use an assured method of contraception for the duration of treatment and three months
after. Assured methods of contraception include i.e. IUCD or depot hormone injection
of medroxyprogesterone acetate MPA (DepoProvera®)

- Platelet count less than 40,000/mm3 (Step 1 only)

- Prothrombin time 5 seconds or greater than normal range (Step 1 only)

- Known hepatitis B, C or known HIV positive

- Patients who present with Para Kala-azar Dermal Leishmaniasis

- Signs/symptoms indicative of severe VL (Hb < 5gm/dl, etc)

- Patients with a previous history of VL

- Patients who have received any investigational (unlicensed) drugs within the last 3
months

- Severe malnutrition BMI<15 in adults, weight for height less than 60% in children

- Clinical symptoms of chronic underlying disease such as severe cardiac, renal or
hepatic impairment

- Positive HRP2/pLDH Combo test for malaria

- Pregnant woman or breast-feeding mother

- Known alcohol or other drug abuse

- Concomitant chronic drug treatment eg. TB, HIV etc.

- Known hypersensitivity to AmBisome, Paromomycin and other aminoglycosides and/or
Miltefosine



Age minimum: 5 Years
Age maximum: 60 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Visceral Leishmaniasis

Intervention(s)

Drug: Liposomal amphotericin B

Drug: liposomal amphotericin B + miltefosine

Drug: liposomal amphotericin B + paromomycin

Drug: Miltefosine + Paromomycin

Primary Outcome(s)

Definitive cure [Time Frame: 6 month post treatment]

Secondary Outcome(s)

Initial Cure [Time Frame: Day 45]

Adverse events [Time Frame: Treatment]

Secondary ID(s)

VLCombo-BD-09

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Shaheed Surhawardy Medical College and Hospital

International Centre for Diarrhoeal Disease Research, Bangladesh