Author:
ProCite
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Reference Manager
BibTeX
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-
1.
Searo W, 2005. Regional Strategic Framework for Elimination of Kala-Azar from South-East Asia Region (2005–2015). New Delhi, India: World Health Organization, Regional Office for South-East Asia.
-
2.
Alvar J, Vélez ID, Bern C, Herrero M, Desjeux P, Cano J, Jannin J, den Boer M; WHO Leishmaniasis Control Team, 2012. Leishmaniasis worldwide and global estimates of its incidence. PLoS ONE 7: e35671.
-
3.
World Health Organization, 2010. Control of the Leishmaniasis. Report of a Meeting of the WHO Expert Committee on the Control of Leishmaniases. Available at: http://whqlibdoc.who.int/trs/WHO_TRS_949_eng.pdf. Accessed June 29, 2011.
-
4.
Bhattacharya SK, Sur D, Sinha PK, Karbwang J, 2006. Elimination of leishmaniasis (kala-azar) from the Indian subcontinent is technically feasible & operationally achievable. Indian J Med Res 123: 195–196.
-
5.
Thakur CP, Sinha GP, Pandey AK, Barat D, Singh RK, 1994. Daily versus alternate-day regimen of amphotericin B in the treatment of kala-azar: a randomized comparison. Bull World Health Organ 72: 931–936.
-
6.
Thakur CP, Narayan S, 2004. A comparative evaluation of amphotericin B and sodium antimony gluconate, as first-line drugs in the treatment of Indian visceral leishmaniasis. Ann Trop Med Parasitol 98: 129–138.
-
7.
Thakur CP, Singh RK, Hassan SM, Kumar R, Narain S, Kumar A, 1999. Amphotericin B deoxycholate treatment of visceral leishmaniasis with newer modes of administration and precautions: a study of 938 cases. Trans R Soc Trop Med Hyg 93: 319–323.
-
8.
Sundar S, Mehta H, Suresh AV, Singh SP, Rai M, Murray HW, 2004. Amphotericin B treatment for Indian visceral leishmaniasis: conventional versus lipid formulations. Clin Infect Dis 38: 377–383.
-
9.
Sundar S, Chakravarty J, Agarwal D, Rai M, Murray HW, 2010. Single-dose liposomal amphotericin B for visceral leishmaniasis in India. N Engl J Med 362: 504–512.
-
10.
Berman JD, Badaro R, Thakur CP, Wasunna KM, Behbehani K, Davidson R, Kuzoe F, Pang L, Weerasuriya K, Bryceson AD, 1998. Efficacy and safety of liposomal amphotericin B (AmBisome) for visceral leishmaniasis in endemic developing countries. Bull World Health Organ 76: 25–32.
-
11.
Sundar S, Jha TK, Thakur CP, Mishra M, Singh VR, Buffels R, 2002. Low-dose liposomal amphotericin B in refractory Indian visceral leishmaniasis: a multicenter study. Am J Trop Med Hyg 66: 143–146.
-
12.
Sundar S, Jha TK, Thakur CP, Mishra M, Singh VP, Buffels R, 2003. Single-dose liposomal amphotericin B in the treatment of visceral leishmaniasis in India: a multicenter study. Clin Infect Dis 37: 800–804.
-
13.
Sundar S, Mehta H, Chhabra A, Singh V, Chauhan V, Desjeux P, Rai M, 2006. Amphotericin B colloidal dispersion for the treatment of Indian visceral leishmaniasis. Clin Infect Dis 42: 608–613.
-
14.
Karande SC, Boby KF, Lahiri KR, Jain MK, Kshirsagar NA, Gokhale PC, Pandya SK, 1995. Successful treatment of antimony-resistant visceral leishmaniasis with liposomal Amphotericin B in a child. Trop Doct 25: 80–81.
-
15.
Mondal S, Bhattacharya P, Rahaman M, Ali N, Goswami RP, 2010. A curative immune profile one week after treatment of Indian kala-azar patients predicts success with a short-course liposomal amphotericin B therapy. PLoS Negl Trop Dis 4: e764.
-
16.
Program CTE, 2002. Common Toxicity Criteria. Available at: http://ctep.cancer.gov/reporting/index.html. Accessed October 7, 2009.
-
17.
Chulay JD, Bryceson AD, 1983. Quantitation of amastigotes of Leishmania donovani in smears of splenic aspirates from patients with visceral leishmaniasis. Am J Trop Med Hyg 32: 475–479.
-
18.
Sundar S, Singh A, Rai M, Prajapati VK, Singh AK, Ostyn B, Boelaert M, Dujardin JC, Chakravarty J, 2012. Efficacy of miltefosine in the treatment of visceral leishmaniasis in India after a decade of use. Clin Infect Dis 55: 543–550.
-
19.
Rahman M, Ahmed BN, Faiz MA, Chowdhury MZ, Islam QT, Sayeedur R, Rahman MR, Hossain M, Bangali AM, Ahmad Z, Islam MN, Mascie-Taylor CG, Berman J, Arana B, 2011. Phase IV trial of miltefosine in adults and children for treatment of visceral leishmaniasis (kala-azar) in Bangladesh. Am J Trop Med Hyg 85: 66–69.
-
20.
Rijal S, Ostyn B, Uranw S, Rai K, Bhattarai NR, Dorlo TP, Beijnen JH, Vanaerschot M, Decuypere S, Dhakal SS, Das ML, Karki P, Singh R, Boelaert M, Dujardin JC, 2013. Increasing failure of miltefosine in the treatment of kala-azar in Nepal and the potential role of parasite drug resistance, reinfection, or noncompliance. Clin Infect Dis 56: 1530–1538.
-
21.
Rijal S, Chappuis F, Singh R, Bovier PA, Acharya P, Karki BM, Das ML, Desjeux P, Loutan L, Koirala S, 2003. Treatment of visceral leishmaniasis in south-eastern Nepal: decreasing efficacy of sodium stibogluconate and need for a policy to limit further decline. Trans R Soc Trop Med Hyg 97: 350–354.
-
22.
Sundar S, More DK, Singh MK, Singh VP, Sharma S, Makharia A, Kumar PC, Murray HW, 2000. Failure of pentavalent antimony in visceral leishmaniasis in India: report from the center of the Indian epidemic. Clin Infect Dis 31: 1104–1107.
-
23.
Mondal DAJ, Hasnain MG, Hossain MS, Ghosh D, Huda MM, Nabi SG, Sundar S, Matlashewski G, Arana D, 2014. Efficacy and safety of single-dose liposomal amphotericin B for visceral leishmaniasis in a rural public hospital in Bangladesh: a feasibility study. Lancet Glob Health 2: e51–e57.
-
24.
Bodhe PV, Kotwani RN, Kirodian BG, Pathare AV, Pandey AK, Thakur CP, Kshirsagar NA, 1999. Dose-ranging studies on liposomal amphotericin B (L-AMP-LRC-1) in the treatment of visceral leishmaniasis. Trans R Soc Trop Med Hyg 93: 314–318.
-
25.
Walsh TJ, Goodman JL, Pappas P, Bekersky I, Buell DN, Roden M, Barrett J, Anaissie EJ, 2001. Safety, tolerance, and pharmacokinetics of high-dose liposomal amphotericin B (AmBisome) in patients infected with Aspergillus species and other filamentous fungi: maximum tolerated dose study. Antimicrob Agents Chemother 45: 3487–3496.
-
26.
Sundar S, Agrawal G, Rai M, Makharia MK, Murray HW, 2001. Treatment of Indian visceral leishmaniasis with single or daily infusions of low dose liposomal amphotericin B: randomised trial. BMJ 323: 419–422.
-
27.
Sanath S, Gogtay NJ, Kshirsagar NA, 2005. Post-marketing study to assess the safety, tolerability and effectiveness of FungisomeTM: an Indian liposomal amphotericin B preparation. J Postgrad Med 51: 58–63.
-
28.
Astellas Pharma US, Inc., 2012. Ambisome (Amphotericin B) Liposome for Injection: Prescribing Information. Available at: http://www.astellas.us/docs/ambisome.pd. Accessed August 20, 2013.
| Past two years | Past Year | Past 30 Days | |
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| Abstract Views | 31 | 31 | 6 |
| Full Text Views | 448 | 138 | 0 |
| PDF Downloads | 124 | 48 | 0 |
Single-Dose Indigenous Liposomal Amphotericin B in the Treatment of Indian Visceral Leishmaniasis: A Phase 2 Study
Shyam Sundar
Shyam Sundar
Department of Medicine, Institute of Medical Sciences, Banaras Hindu University, Varanasi, India
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Anup Singh
Anup Singh
Department of Medicine, Institute of Medical Sciences, Banaras Hindu University, Varanasi, India
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Madhukar Rai
Madhukar Rai
Department of Medicine, Institute of Medical Sciences, Banaras Hindu University, Varanasi, India
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Jaya Chakravarty
Jaya Chakravarty
Department of Medicine, Institute of Medical Sciences, Banaras Hindu University, Varanasi, India
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Liposomal amphotericin B is an effective and safe alternative for the treatment of visceral leishmaniasis in the Indian subcontinent. In this study, we used a higher-dose regimen of an indigenously manufactured liposomal amphotericin B (FUNGISOME; L-AmBL), which was intended to improve the efficacy in terms of long-lasting cure rate. Thirty men and thirty women between 12 and 60 years old with parasitologically confirmed visceral leishmaniasis were enrolled in two cohorts of 15 patients each. Subjects in cohort I were administered one dose (10 mg/kg body weight) of L-AmBL intravenously. After the safety at this dose was confirmed in cohort I, patients were recruited in cohort II. They received one infusion of an escalated dose (15 mg/kg body weight). The safety of these two doses was evaluated over a period of 30 days, and efficacy was assessed for initial cure at day 30 and definitive cure at 6 months. FUNGISOME was found to be safe, with an initial cure rate of 100% at day 30 and a definitive cure rate of 93.3% at the 6-month follow-up in both the cohorts.
Author Notes
Authors' addresses: Shyam Sundar, Anup Singh, Madhukar Rai, and Jaya Chakravarty, Department of Medicine, Institute of Medical Sciences, Banaras Hindu University, Varanasi, India, E-mails: drshyamsundar@hotmail.com, dranupbhu@gmail.com, rai_madhukar@sify.com, and tapadar@gmail.com.
ProCite
RefWorks
Reference Manager
BibTeX
Zotero
EndNote
-
1.
Searo W, 2005. Regional Strategic Framework for Elimination of Kala-Azar from South-East Asia Region (2005–2015). New Delhi, India: World Health Organization, Regional Office for South-East Asia.
-
2.
Alvar J, Vélez ID, Bern C, Herrero M, Desjeux P, Cano J, Jannin J, den Boer M; WHO Leishmaniasis Control Team, 2012. Leishmaniasis worldwide and global estimates of its incidence. PLoS ONE 7: e35671.
-
3.
World Health Organization, 2010. Control of the Leishmaniasis. Report of a Meeting of the WHO Expert Committee on the Control of Leishmaniases. Available at: http://whqlibdoc.who.int/trs/WHO_TRS_949_eng.pdf. Accessed June 29, 2011.
-
4.
Bhattacharya SK, Sur D, Sinha PK, Karbwang J, 2006. Elimination of leishmaniasis (kala-azar) from the Indian subcontinent is technically feasible & operationally achievable. Indian J Med Res 123: 195–196.
-
5.
Thakur CP, Sinha GP, Pandey AK, Barat D, Singh RK, 1994. Daily versus alternate-day regimen of amphotericin B in the treatment of kala-azar: a randomized comparison. Bull World Health Organ 72: 931–936.
-
6.
Thakur CP, Narayan S, 2004. A comparative evaluation of amphotericin B and sodium antimony gluconate, as first-line drugs in the treatment of Indian visceral leishmaniasis. Ann Trop Med Parasitol 98: 129–138.
-
7.
Thakur CP, Singh RK, Hassan SM, Kumar R, Narain S, Kumar A, 1999. Amphotericin B deoxycholate treatment of visceral leishmaniasis with newer modes of administration and precautions: a study of 938 cases. Trans R Soc Trop Med Hyg 93: 319–323.
-
8.
Sundar S, Mehta H, Suresh AV, Singh SP, Rai M, Murray HW, 2004. Amphotericin B treatment for Indian visceral leishmaniasis: conventional versus lipid formulations. Clin Infect Dis 38: 377–383.
-
9.
Sundar S, Chakravarty J, Agarwal D, Rai M, Murray HW, 2010. Single-dose liposomal amphotericin B for visceral leishmaniasis in India. N Engl J Med 362: 504–512.
-
10.
Berman JD, Badaro R, Thakur CP, Wasunna KM, Behbehani K, Davidson R, Kuzoe F, Pang L, Weerasuriya K, Bryceson AD, 1998. Efficacy and safety of liposomal amphotericin B (AmBisome) for visceral leishmaniasis in endemic developing countries. Bull World Health Organ 76: 25–32.
-
11.
Sundar S, Jha TK, Thakur CP, Mishra M, Singh VR, Buffels R, 2002. Low-dose liposomal amphotericin B in refractory Indian visceral leishmaniasis: a multicenter study. Am J Trop Med Hyg 66: 143–146.
-
12.
Sundar S, Jha TK, Thakur CP, Mishra M, Singh VP, Buffels R, 2003. Single-dose liposomal amphotericin B in the treatment of visceral leishmaniasis in India: a multicenter study. Clin Infect Dis 37: 800–804.
-
13.
Sundar S, Mehta H, Chhabra A, Singh V, Chauhan V, Desjeux P, Rai M, 2006. Amphotericin B colloidal dispersion for the treatment of Indian visceral leishmaniasis. Clin Infect Dis 42: 608–613.
-
14.
Karande SC, Boby KF, Lahiri KR, Jain MK, Kshirsagar NA, Gokhale PC, Pandya SK, 1995. Successful treatment of antimony-resistant visceral leishmaniasis with liposomal Amphotericin B in a child. Trop Doct 25: 80–81.
-
15.
Mondal S, Bhattacharya P, Rahaman M, Ali N, Goswami RP, 2010. A curative immune profile one week after treatment of Indian kala-azar patients predicts success with a short-course liposomal amphotericin B therapy. PLoS Negl Trop Dis 4: e764.
-
16.
Program CTE, 2002. Common Toxicity Criteria. Available at: http://ctep.cancer.gov/reporting/index.html. Accessed October 7, 2009.
-
17.
Chulay JD, Bryceson AD, 1983. Quantitation of amastigotes of Leishmania donovani in smears of splenic aspirates from patients with visceral leishmaniasis. Am J Trop Med Hyg 32: 475–479.
-
18.
Sundar S, Singh A, Rai M, Prajapati VK, Singh AK, Ostyn B, Boelaert M, Dujardin JC, Chakravarty J, 2012. Efficacy of miltefosine in the treatment of visceral leishmaniasis in India after a decade of use. Clin Infect Dis 55: 543–550.
-
19.
Rahman M, Ahmed BN, Faiz MA, Chowdhury MZ, Islam QT, Sayeedur R, Rahman MR, Hossain M, Bangali AM, Ahmad Z, Islam MN, Mascie-Taylor CG, Berman J, Arana B, 2011. Phase IV trial of miltefosine in adults and children for treatment of visceral leishmaniasis (kala-azar) in Bangladesh. Am J Trop Med Hyg 85: 66–69.
-
20.
Rijal S, Ostyn B, Uranw S, Rai K, Bhattarai NR, Dorlo TP, Beijnen JH, Vanaerschot M, Decuypere S, Dhakal SS, Das ML, Karki P, Singh R, Boelaert M, Dujardin JC, 2013. Increasing failure of miltefosine in the treatment of kala-azar in Nepal and the potential role of parasite drug resistance, reinfection, or noncompliance. Clin Infect Dis 56: 1530–1538.
-
21.
Rijal S, Chappuis F, Singh R, Bovier PA, Acharya P, Karki BM, Das ML, Desjeux P, Loutan L, Koirala S, 2003. Treatment of visceral leishmaniasis in south-eastern Nepal: decreasing efficacy of sodium stibogluconate and need for a policy to limit further decline. Trans R Soc Trop Med Hyg 97: 350–354.
-
22.
Sundar S, More DK, Singh MK, Singh VP, Sharma S, Makharia A, Kumar PC, Murray HW, 2000. Failure of pentavalent antimony in visceral leishmaniasis in India: report from the center of the Indian epidemic. Clin Infect Dis 31: 1104–1107.
-
23.
Mondal DAJ, Hasnain MG, Hossain MS, Ghosh D, Huda MM, Nabi SG, Sundar S, Matlashewski G, Arana D, 2014. Efficacy and safety of single-dose liposomal amphotericin B for visceral leishmaniasis in a rural public hospital in Bangladesh: a feasibility study. Lancet Glob Health 2: e51–e57.
-
24.
Bodhe PV, Kotwani RN, Kirodian BG, Pathare AV, Pandey AK, Thakur CP, Kshirsagar NA, 1999. Dose-ranging studies on liposomal amphotericin B (L-AMP-LRC-1) in the treatment of visceral leishmaniasis. Trans R Soc Trop Med Hyg 93: 314–318.
-
25.
Walsh TJ, Goodman JL, Pappas P, Bekersky I, Buell DN, Roden M, Barrett J, Anaissie EJ, 2001. Safety, tolerance, and pharmacokinetics of high-dose liposomal amphotericin B (AmBisome) in patients infected with Aspergillus species and other filamentous fungi: maximum tolerated dose study. Antimicrob Agents Chemother 45: 3487–3496.
-
26.
Sundar S, Agrawal G, Rai M, Makharia MK, Murray HW, 2001. Treatment of Indian visceral leishmaniasis with single or daily infusions of low dose liposomal amphotericin B: randomised trial. BMJ 323: 419–422.
-
27.
Sanath S, Gogtay NJ, Kshirsagar NA, 2005. Post-marketing study to assess the safety, tolerability and effectiveness of FungisomeTM: an Indian liposomal amphotericin B preparation. J Postgrad Med 51: 58–63.
-
28.
Astellas Pharma US, Inc., 2012. Ambisome (Amphotericin B) Liposome for Injection: Prescribing Information. Available at: http://www.astellas.us/docs/ambisome.pd. Accessed August 20, 2013.
| Past two years | Past Year | Past 30 Days | |
|---|---|---|---|
| Abstract Views | 31 | 31 | 6 |
| Full Text Views | 448 | 138 | 0 |
| PDF Downloads | 124 | 48 | 0 |