Efficacy Trial of Ambisome Given Alone and Ambisome Given in Combination With Miltefosine for the Treatment of VL HIV Positive Ethiopian Patients.

PHASE3CompletedINTERVENTIONAL
Enrollment

59

Participants

Timeline

Start Date

July 31, 2014

Primary Completion Date

August 31, 2016

Study Completion Date

September 15, 2017

Conditions
Visceral Leishmaniasis
Interventions
DRUG

Liposomal Amphotericin B

"40 mg/kg total dose: IV infusion of 5mg/kg per day on day 1 to 5, 10,17,24 (when administered as a monotherapy)~30 mg/kg total dose: IV infusion 5 mg/kg per day on day 1, 3, 5, 7, 9, 11 (when administered in combination with Miltefosine)"

DRUG

Miltefosine

"Orally taken every day during 28 days~* 1 x 50 mg capsule per day if the patient weights less or equal to 25 kg~* 2 x 50 mg capsules per day if the patient weights more than 25 kg (1 capsule in the morning / 1 capsule in the evening)"

Trial Locations (2)

Unknown

MSF, Abdurafi

Leishmaniasis Research Center, University Hospital of Gondar, Gonder

All Listed Sponsors
collaborator

Medecins Sans Frontieres, Netherlands

OTHER

collaborator

London School of Hygiene and Tropical Medicine

OTHER

collaborator

Addis Ababa University

OTHER

collaborator

Institute of Tropical Medicine, Belgium

OTHER

collaborator

Slotervaart Hospital

OTHER

collaborator

University of Gondar

OTHER

lead

Drugs for Neglected Diseases

OTHER

NCT02011958 - Efficacy Trial of Ambisome Given Alone and Ambisome Given in Combination With Miltefosine for the Treatment of VL HIV Positive Ethiopian Patients. | Biotech Hunter | Biotech Hunter