Combination Therapy in Indian Visceral Leishmaniasis
Information source: Banaras Hindu University
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Leishmaniasis, Visceral
Intervention: amphotericin B deoxycholate (Drug); Liposomal Amphotericin B with Miltefosine (Drug); Liposomal Amphotericin B and Paromomycin Sulfate (Drug); miltefosine + Paromomycin sulfate (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Banaras Hindu University Official(s) and/or principal investigator(s):
Shyam Sundar, MD, Principal Investigator, Affiliation: Institute of Medical Sciences, Banaras HIndu University
P K Sinha, MD, Principal Investigator, Affiliation: Rajendra Memorial Research Insititute of Medical Sciences
Overall contact:
Shyam Sundar, MD, Phone: 91-621-2287570, Email: drshyamsundar@hotmail.com
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.
Clinical Details
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)
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: Final cure at six month follow upCure at six month follow up
Secondary outcome: Initial cure at the end of treatment
Eligibility
Minimum age: 12 Years.
Maximum age: 60 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Shyam Sundar, MD, Phone: 91-621-2287570, Email: drshyamsundar@hotmail.com
Kala-azar Medical Research Center, Muzaffarpur, Bihar 842001, India; Recruiting
Kumar Dheeraj, Phone: 91-621-2287570, Email: kamrcmfp@hotmail.com
Additional Information
Starting date: September 2007
Ending date: October 2009
Last updated: January 8, 2009
|
