Liposomal amphotericin B (Fungisome) for the treatment of cryptococcal meningitis in HIV/AIDS patients in India: a multicentric, randomized controlled trial.
BACKGROUND
There is need to investigate the use of liposomal amphotericin B in cryptococcal meningitis in India.


OBJECTIVE
To compare the efficacy, safety, duration of treatment and cost of two doses of liposomal amphotericin B (Amp B) (Fungisome) in cryptococcal meningitis in HIV/AIDS patients.


METHODS
Prospective, randomized, multicenter study in tertiary care hospitals across India.


METHODS
Adult patients with culture-proven cryptococcal meningitis with HIV/AIDS were randomized to receive either 1 (Group A) or 3 mg/kg/day of Fungisome (Group B). Clinical efficacy and tolerability, laboratory evaluations and mycological response were assessed daily, twice weekly and weekly respectively. The patients were assessed at four and eight-week follow-up.


METHODS
We calculated average and standard deviation for the various parameters.


RESULTS
The time to show clinical response was 13.66 days (1 mg) and 9.55 days (3 mg). In Group B (n=6 complete response), 50% patients responded within one week by microbial conversion, 83% in two weeks and 100% in three weeks. Patients with 1 mg dose (n=4 complete response), none showed microbial conversion within one week, 75% responded in two weeks, whereas one patient took four weeks. The average duration of treatment was 36.5+/-14.4 and 26.5+/-5.89 (S.D.) days in 1 and 3 mg/kg/day respectively. Drug was tolerated with little renal, hepatic or hematological toxicity. The cost was found to be 3.81 lacs and 1.74 lacs with 3mg/kg/day and 1mg/kg/day respectively.


CONCLUSIONS
Higher dose showed better efficacy and quicker microbial conversion of Cerebrospinal fluid (CSF) (cerebrospinal fluid) than 1 mg/kg/day. It shortened the duration of treatment in days by 27% while drug cost almost doubled (


BACKGROUND
ISRCTN 52812742).
Jadhav
M P
MP
Department of Clinical Pharmacology, Seth G.S. Medical College and KEM Hospital, Mumbai-400 012, India.
Bamba
A
A
Shinde
V M
VM
Gogtay
N
N
Kshirsagar
N A
NA
Bichile
L S
LS
Mathai
D
D
Sharma
A
A
Varma
S
S
Digumarathi
R
R
D017088:AIDS-Related Opportunistic Infections / Q000150:complications / Q000188:drug therapy* / Q000382:microbiology; D000328:Adult; D000666:Amphotericin B / Q000008:administration & dosage*; D000935:Antifungal Agents / Q000008:administration & dosage*; D002555:Cerebrospinal Fluid / Q000382:microbiology; D003455:Cryptococcus neoformans / Q000187:drug effects / Q000302:isolation & purification; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D015658:HIV Infections / Q000150:complications*; D006801:Humans; D008297:Male; D016919:Meningitis, Cryptococcal / Q000150:complications / Q000188:drug therapy* / Q000382:microbiology; D011446:Prospective Studies; D016896:Treatment Outcome; D055815:Young Adult
D000935:Antifungal Agents; C068538:liposomal amphotericin B; D000666:Amphotericin B