title: Liposomal amphotericin B (Fungisome) for the treatment of cryptococcal meningitis in HIV/AIDS patients in India: a multicentric, randomized controlled trial.
abstract: 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).
authors.affiliation: Department of Clinical Pharmacology, Seth G.S. Medical College and KEM Hospital, Mumbai-400 012, India.
authors.forename: M P
authors.initials: MP
authors.lastname: Jadhav
authors.forename: A
authors.initials: A
authors.lastname: Bamba
authors.forename: V M
authors.initials: VM
authors.lastname: Shinde
authors.forename: N
authors.initials: N
authors.lastname: Gogtay
authors.forename: N A
authors.initials: NA
authors.lastname: Kshirsagar
authors.forename: L S
authors.initials: LS
authors.lastname: Bichile
authors.forename: D
authors.initials: D
authors.lastname: Mathai
authors.forename: A
authors.initials: A
authors.lastname: Sharma
authors.forename: S
authors.initials: S
authors.lastname: Varma
authors.forename: R
authors.initials: R
authors.lastname: Digumarathi
mesh_terms: 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
chemical_list: D000935:Antifungal Agents; C068538:liposomal amphotericin B; D000666:Amphotericin B