A Phase 3 interventional study of amphotericin B deoxycholate and Liposomal Amphotericin B with Miltefosine in Leishmaniasis, Visceral, sponsored by Banaras Hindu University. Completed at 1 site in India. Open to participants aged 12 Years to 60 Years. Per ClinicalTrials.gov, last updated 2010-05-26.
Sponsored by Banaras Hindu University · Phase 3, Interventional, and Treatment
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.
185 studies on the registry are indexed under Leishmaniasis; 15 are open to participants now.
This study's planned enrollment of 624 is above the median of 80 across 133 interventional studies indexed under Leishmaniasis.
Browse Leishmaniasis studies →Banaras Hindu University is the lead sponsor of 19 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
AmBisome 5 mg/kg iv infusion over 2 h x 1 day (single dose) + 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 7 days on day 2-8
Drug: Liposomal Amphotericin B with Miltefosine
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: Liposomal Amphotericin B and 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
Drug: miltefosine + Paromomycin sulfate
amphotericin B deoxycholate at 1 mg/kg every other day for 15 infusions
Drug: amphotericin B deoxycholate
Amphotericin B deoxycholate 1 mg/kg on alternate days for 15 infusions
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
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
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
Final cure at six month follow up
Time frame: 18 months
Cure at six month follow up
Time frame: 12 months
Initial cure at the end of treatment
Time frame: 12 months
This study is completed, as verified in Jan 2009. You cannot join it, but the record below documents what was studied.
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Banaras Hindu University