Combination Therapy in Indian Visceral Leishmaniasis - Tabular View

Tracking Information

First Received Date ^ICMJE

August 31, 2007

Last Updated Date

January 8, 2009

Start Date ^ICMJE

September 2007

Estimated Primary Completion Date

September 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Final cure at six month follow up [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
Cure at six month follow up [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Final cure at six month follow up [ Time Frame: 18 months ]

Change History

Complete list of historical versions of study NCT00523965 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Initial cure at the end of treatment [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Initial cure at the end of treatment [ Time Frame: 12 months ]

Descriptive Information

Brief Title ^ICMJE

Combination Therapy in Indian Visceral Leishmaniasis

Official Title ^ICMJE

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)

Brief 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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Leishmaniasis, Visceral

Intervention ^ICMJE

Drug: amphotericin B deoxycholate
Drug: Liposomal Amphotericin B with Miltefosine
Drug: Liposomal Amphotericin B and Paromomycin Sulfate
Drug: miltefosine + Paromomycin sulfate

Study Arms / Comparison Groups

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
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
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
Active Comparator: amphotericin B deoxycholate at 1 mg/kg every other day for 15 infusions

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

624

Estimated Completion Date

October 2009

Estimated Primary Completion Date

September 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patients > 5 years old with symptoms and signs of kala-azar (fever, weight loss, splenomegaly) and parasites demonstrated by microscopy in splenic aspirate smear

Exclusion Criteria:

Pregnant or breast-feeding women
Individuals seropositive to HIV or individuals with a serious concurrent infection such as tuberculosis or bacterial pneumonia.
Women of child-bearing age will be counseled about adequate birth control during and for three months after miltefosine treatment and provided with a satisfactory method of contra-ception.
Granulocyte count < 1,000/mm3, hemoglobin < 5 g/dL or platelet count < 40,000/mm3
Hepatic transaminases or total bilirubin greater than three times normal
Serum creatinine > 2.0 mg/dL
Prothrombin time > 5 seconds above control
Inability of subject or guardian to provide written informed consent

Gender

Both

Ages

12 Years to 60 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Shyam Sundar, MD

91-621-2287570

drshyamsundar@hotmail.com

Location Countries ^ICMJE

India

Administrative Information

NCT ID ^ICMJE

NCT00523965

Responsible Party

Shyam Sundar, Drugs for Neglected Diseases Initiative

Study ID Numbers ^ICMJE

VLCombo 07

Study Sponsor ^ICMJE

Banaras Hindu University

Collaborators ^ICMJE

Drugs for Neglected Diseases
Rajendra Memorial Research Institute of Medical Sciences

Investigators ^ICMJE

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

Information Provided By

Banaras Hindu University

Verification Date

January 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP