Ambisome plus miltefosine for Indian patients with kala-azar.
The combination of one intravenous administration of 5mg/kg Ambisome and oral administration of miltefosine, 2.5mg/kg/day for 14 days, was evaluated in 135 Indian patients with kala-azar. The Intent-to-Treat cure rate at 6 months was 124 of the 135 enrolled patients (91.9%: 95% CI = 86-96%), and the per protocol cure rate was 124 of 127 evaluable patients (97.6%: 95% CI = 93-100%). Side effects could be attributed to each drug separately: fevers, rigors and back pain due to Ambisome; gastrointestinal side effects due to miltefosine. This combination is attractive for reasons of efficacy, tolerance, and feasibility of administration, although the gastrointestinal side effects of miltefosine require medical vigilance. Clinical Trials.gov identification number: NCT00371995.
Kala-azar Medical Research Center, Department of Medicine, Institute of Medical Sciences, Banaras Hindu University, Varanasi 221005, India.
Shyam
S
Sundar
Prabhat Kumar
PK
Sinha
Deepak K
DK
Verma
Nawin
N
Kumar
Shahnawaj
S
Alam
Krishna
K
Pandey
Poonam
P
Kumari
Vidyanand
V
Ravidas
Jaya
J
Chakravarty
Neena
N
Verma
Jonathan
J
Berman
Hashim
H
Ghalib
Byron
B
Arana
D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D000666:Amphotericin B / Q000008:administration & dosage*; D000981:Antiprotozoal Agents / Q000008:administration & dosage* / Q000009:adverse effects; D002648:Child; D002675:Child, Preschool; D004359:Drug Therapy, Combination / Q000379:methods; D005260:Female; D005767:Gastrointestinal Diseases / Q000139:chemically induced; D006801:Humans; D007262:Infusions, Intravenous; D007898:Leishmaniasis, Visceral / Q000150:complications / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D010767:Phosphorylcholine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D016896:Treatment Outcome; D055815:Young Adult
D000981:Antiprotozoal Agents; C068538:liposomal amphotericin B; D010767:Phosphorylcholine; C039128:miltefosine; D000666:Amphotericin B