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Liposomal amphotericin B (Fungisome) for the treatment of cryptococcal meningitis in HIV/AIDS patients in India: a multicentric, randomized controlled trial.

Author(s): Jadhav MP, Bamba A, Shinde VM, Gogtay N, Kshirsagar NA, Bichile LS, Mathai D, Sharma A, Varma S, Digumarathi R

Affiliation(s): Department of Clinical Pharmacology, Seth G.S. Medical College and KEM Hospital, Mumbai-400 012, India.

Publication date & source: 2010-04, J Postgrad Med., 56(2):71-5.

Publication type: Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't

BACKGROUND: There is need to investigate the use of liposomal amphotericin B in cryptococcal meningitis in India. AIMS : 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. SETTINGS AND DESIGN: Prospective, randomized, multicenter study in tertiary care hospitals across India. MATERIALS AND 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. STATISTICS: 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. CONCLUSION: 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 (Clinical trial registration number: ISRCTN 52812742).

Page last updated: 2010-10-05

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