Clinical Trial: Combination Therapy in Indian Visceral Leishmaniasis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Randomised, Open-label, Parallel-group, Safety and Efficacy Study to Evaluate Different Combination Treatment Regimens (Co-administration), of AmBisome, Paromomycin and Miltefosine in 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.
Detailed Summary:
Sponsor: Banaras Hindu University
Current Primary Outcome:
- Final cure at six month follow up [ Time Frame: 18 months ]
- Cure at six month follow up [ Time Frame: 12 months ]
Original Primary Outcome: Final cure at six month follow up [ Time Frame: 18 months ]
Current Secondary Outcome: Initial cure at the end of treatment [ Time Frame: 12 months ]
Original Secondary Outcome: Same as current
Information By: Banaras Hindu University
Dates:
Date Received: August 31, 2007
Date Started: September 2007
Date Completion:
Last Updated: May 25, 2010
Last Verified: January 2009
