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| Sponsor: | Banaras Hindu University |
|---|---|
| Collaborators: |
Drugs for Neglected Diseases Rajendra Memorial Research Institute of Medical Sciences |
| Information provided by: | Banaras Hindu University |
| ClinicalTrials.gov Identifier: | NCT00523965 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Leishmaniasis, Visceral |
Drug: amphotericin B deoxycholate Drug: Liposomal Amphotericin B with Miltefosine Drug: Liposomal Amphotericin B and Paromomycin Sulfate Drug: miltefosine + Paromomycin sulfate |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | A Randomised, Open-Label, Parallel-Group, Safety and Efficacy Study to Evaluate Different Combination Treatment Regimens (co-Administration), of AmBisome, Paromomycinand Miltefosine in Visceral Leishmaniasis (VL) |
| Estimated Enrollment: | 624 |
| Study Start Date: | September 2007 |
| Estimated Study Completion Date: | October 2009 |
| Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
A: Experimental
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
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
|
|
B: Experimental
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
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
|
|
C: Experimental
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
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
|
|
D: Active Comparator
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
|
Eligibility| Ages Eligible for Study: | 12 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Shyam Sundar, MD | 91-621-2287570 | drshyamsundar@hotmail.com |
| India, Bihar | |
| Kala-azar Medical Research Center | Recruiting |
| Muzaffarpur, Bihar, India, 842001 | |
| Contact: Kumar Dheeraj 91-621-2287570 kamrcmfp@hotmail.com | |
| Principal Investigator: | Shyam Sundar, MD | Institute of Medical Sciences, Banaras HIndu University |
| Principal Investigator: | P K Sinha, MD | Rajendra Memorial Research Insititute of Medical Sciences |
More Information
| Responsible Party: | Drugs for Neglected Diseases Initiative ( Shyam Sundar ) |
| Study ID Numbers: | VLCombo 07 |
| Study First Received: | August 31, 2007 |
| Last Updated: | January 8, 2009 |
| ClinicalTrials.gov Identifier: | NCT00523965 History of Changes |
| Health Authority: | India: Ministry of Health |
|
Kala-azar miltefosine liposomal amphotericin B |
|
Abelcet Anti-Infective Agents Antiprotozoal Agents Skin Diseases, Parasitic Antineoplastic Agents Miltefosine Mastigophora Infections Liposomal amphotericin B Paromomycin Anti-Bacterial Agents Antiparasitic Agents Cholagogues and Choleretics Therapeutic Uses Antifungal Agents |
Deoxycholic Acid Antibiotics, Antifungal Parasitic Diseases Leishmaniasis, Visceral Amphotericin B-deoxycholate Amebicides Leishmaniasis Amphotericin B Protozoan Infections Skin Diseases Gastrointestinal Agents Pharmacologic Actions Skin Diseases, Infectious Sarcomastigophora Infections |
