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 ORIGINAL ARTICLE
Year : 2010  |  Volume : 56  |  Issue : 2  |  Page : 71-75

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


1 Department of Clinical Pharmacology, Seth G.S. Medical College and KEM Hospital, Mumbai-400 012, India
2 Department of Medicine, Seth G.S. Medical College and KEM, Hospital, Mumbai-400 012, India
3 Department of Medicine and Infectious Disease, Christian Medical College, Vellore, Tamil Nadu, India
4 Department of Medical Oncology, All India Institute of Medical Sciences, New Delhi, India
5 Department of Medicine, Post Graduate Institute of Medical Sciences, Chandigarh, India
6 Department of Medical Oncology, Nizam's Institute of Medical Sciences, Hyderabad, India

Correspondence Address:
M P Jadhav
Department of Clinical Pharmacology, Seth G.S. Medical College and KEM Hospital, Mumbai-400 012
India
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Source of Support: Department of Biotechnology, New Delhi, India for providing the funds to conduct the study, Conflict of Interest: None


DOI: 10.4103/0022-3859.65276

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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 TM ) 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: ISRTCN 52812742)






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Online since 12th February '04
2004 - Journal of Postgraduate Medicine
Official Publication of the Staff Society of the Seth GS Medical College and KEM Hospital, Mumbai, India
Published by Wolters Kluwer - Medknow