NCT01067443 - Clinical Trial to Assess the Safety and Efficacy of Sodium Stibogluconate (SSG) and AmBisome® Combination, Miltefosine and AmBisome® and Miltefosine Alone for the Treatment Visceral Leishmaniasis in Eastern Africa | Biotech Hunter

Enrollment

151

Participants

Timeline

Start Date

March 31, 2010

Primary Completion Date

June 30, 2011

Study Completion Date

June 30, 2011

Conditions

Primary Visceral Leishmaniasis

Interventions

DRUG

Liposomal amphotericin B (AmBisome®) and sodium stibogluconate

AmBisome® one dose of 10mg/kg body weight (IV) on day 1 followed by 10 days of SSG at 20mg/kg body weight (IV/IM) from days 2-11

DRUG

Liposomal amphotericin B + miltefosine

AmBisome® one dose of 10mg/kg body weight (IV) on day 1 followed by 10 days Miltefosine at 2.5mg/kg body weight (oral) from days 2-11

DRUG

Miltefosine

Monotherapy course of Miltefosine at 2.5mg/kg body weight (oral) from days 1-28

Trial Locations (3)

Kimalel Health Centre, Kimalel

Kassab Hospital, Kassāb

El Hassan Centre for Tropical Medicine, Doka