NCT00523965

Combination Therapy in Indian Visceral Leishmaniasis

A Randomised, Open-label, Parallel-group, Safety and Efficacy Study to Evaluate Different Combination Treatment Regimens (Co-administration), of AmBisome, Paromomycin and Miltefosine in Visceral Leishmaniasis (VL)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 624 (estimated)
• Sponsor: Banaras Hindu University · Academic / Other
• Sex: All
• Age: 12 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

Rationale The overall objective of this trial is to identify a safe and effective combination, (co-administration) short course treatment for the treatment of VL which could be easily deployed in a control programme. The hypothesis is that the combination treatment is as effective or better than the 5 mg/kg single dose of AmBisome and will reduce the risk of parasite resistance occurring. Safety and tolerability should be such that the combination can be easily deployed. Objective The specific primary and secondary objectives are as follows: Primary objective: To identify a short course combination treatment regimen which is at least as effective as a single dose of AmBisome 5mg/kg Secondary objective: To compare safety and tolerability of the various treatments measured by vital signs, blood biochemistry, (renal and liver function tests) haematology, spontaneous and elicited adverse event reporting Primary Endpoint: The primary efficacy endpoint variable is parasitological clearance 2 weeks after start of treatment with no relapse during follow up and no clinical signs or symptoms of VL at 6 months post treatment. Parasitology is only carried out at any time during follow-up or at six months post treatment if there are signs or symptoms of VL infection.

Conditions

• Leishmaniasis, Visceral

Interventions

Type	Name	Description
DRUG	amphotericin B deoxycholate	Amphotericin B deoxycholate 1 mg/kg on alternate days for 15 infusions
DRUG	Liposomal Amphotericin B with Miltefosine	Liposomal Amphotericin B 5 mg Miltefosine 50 mg twice daily if patient weighs equal to or \> 25 kg Miltefosine 50 mg once daily if patient weighs \<25 mg
DRUG	Liposomal Amphotericin B and Paromomycin Sulfate	AmBisome 5mg/kg iv infusion over 2 h x 1 day (single dose) + paromomycin sulfate 15 mg/kg/day i.m for 10 days, on day 2-11
DRUG	miltefosine + Paromomycin sulfate	oral miltefosine 50mg once daily (\< 25 kg body weight) or twice daily ( \> 25 kg body weight) or 2.5 mg/kg for children under 12 years, for 10 days + Paromomycin sulfate 15 mg/kg/day im. for 10 days

Timeline

• Start date: 2007-09-01
• Primary completion: 2009-08-01
• Completion: 2010-02-01
• First posted: 2007-09-03
• Last updated: 2010-05-26

Locations

1 site across 1 country: India