Open-Label, Sequential Step, Safety and Efficacy Study to Determine the Optimal Single Dose of Ambisome for Patients With VL

Drugs for Neglected Diseases

Status and phase

Terminated

Phase 2

Conditions

Visceral Leishmaniasis

Treatments

Drug: Liposomal amphotericin B (Ambisome)

Study type

Interventional

Funder types

Other

Identifiers

NCT00832208

AMBI 0106

Details and patient eligibility

About

This is a phase II/III open, comparative dose trial to find the lowest single dose of AmBisome for the treatment of primary, symptomatic visceral leishmaniasis(VL), in HIV negative patients. In this trial, the minimum effective dose will be determined in a sequential step, dose escalation design, which minimises the number of patients exposed to low, potentially inadequate doses and provides contemporaneous comparative data against the manufacturer's recommended dose schedule in this indication.

Enrollment

124 patients

Sex

All

Ages

4+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male and female adults and children aged 4 years or older with no upper age limit (in accordance with manufacturer's instructions)
Acute, symptomatic, VL proven by parasitological examination of splenic aspirate (or bone marrow aspirate) with initial parasite index of at least 2+
Haemoglobin >4g/dL
Fever for more than 2 weeks
Living within reachable distance of the trial site to enable attendance for follow-up visits
Written informed consent to participate (for children, by parent or guardian)
HIV negative status

Exclusion criteria

Patients 'in extremis' with signs/symptoms indicative of severe VL
Patients who have received any anti-leishmanial treatment within the last 6 months
Patients who have received any investigational (unlicensed) drugs during 6 months before recruitment
Known underlying chronic disease, such as severe cardiac, pulmonary, renal, or hepatic impairment.
Renal function tests (serum creatinine) outside the normal range
Liver function tests more than 3 times the normal range at study entry
Platelet count less than 40,000/ mm3
Known alcohol abuse
Pregnancy or lactation
Concomitant acute drug usage for malaria and bacterial infection, pneumonia within last 7 days
Known hypersensitivity to AmBisome or amphotericin B
Any other condition which may invalidate the trial