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

• Status: Completed
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This protocol will evaluate the efficacy and safety of various combinations of the three drugs; AmBisome, Paromomycin and Miltefosine at reduced total dosage against the standard treatment with a total dose of 15mg/kg of AmBisome.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Drugs for Neglected Diseases
• Collaborators: International Centre for Diarrhoeal Disease Research, Bangladesh; Shaheed Surhawardy Medical College and Hospital
• Treatments: Amphotericin B; Liposomal amphotericin B; Miltefosine; Paromomycin

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