Skip to main content

Advertisement

Table 2 Summary of studies and clinical trials on monotherapy in treatment of visceral leishmaniasis in India

From: Current challenges in treatment options for visceral leishmaniasis in India: a public health perspective

Authors Year Drug Type of study Patients (N) Treatment Scheme Cure rate Reference
Thakur et al. 1988 Pentavalent antimonials Randomized dose finding trial of SSG 371 20 vs. 10 mg Sbv+/kg/day for 28 days (i.m) 60–100 % [108]
Thakur et al. 1991 Pentavalent antimonials Randomized trial 312 20 mg Sbv+/kg/day for 20, 30 & 40 days (i.m) 71–94 % [109]
Mishra et al. 1991 Amphotericin B deoxycholate Non-Comparative study 15 0.5 mg/kg/day for 28 days (i.v) 93 % [110]
Mishra et al. 1992 Amphotericin B deoxycholate vs. Pentamidicine Randomized comparative study in antimony unresponsive patients 120 AB: 0.5 mg/kg/on alternate day for 14 days (i.v) 77–98 % [111]
Pentamidinine: 4 mg/kg on alternate days for 20 injections (i.m)
Thakur et al. 1993 Amphotericin B deoxycholate Non comparative study on SSG resistant patients 300 1.0 mg/kg on alternate day, total dose 20 mg/kg (i.v) 99 % [19]
Thakur et al. 1993 Amphotericin B deoxycholate vs. Pentavalent antimonials Randomized controlled comparative trial 150 AB: 1.0 mg/kg on alternate day, total dose 20 mg/kg (i.v) 80–100 % [112]
SSG: 20 vs. 10 mg Sbv+/kg/day for 30 days (i.m)
Mishra et al. 1994 Amphotericin B deoxycholate vs. Pentavalent antimonials Randomized controlled comparative trial 80 AB: 0.5 mg/kg on alternate day for 14 days (i.v) 62–100 % [113]
SSG: 20 mg Sbv+/kg/day for 40 days (i.m)
Thakur et. al. 1994 Amphotericin B deoxycholate Radomized dose finding study 80 1.0 mg/kg on daily vs. alternate day, total dose 20 mg/kg (i.v) 100 % [114]
Thakur et. al. 1994 Amphotericin B deoxycholate Dose finding study 120 1.0 mg/kg/day on incremental increasing dose vs. contantdoase, total dose 20 mg/kg (i.v) 100 % [115]
Giri 1994 Amphotericin B deoxycholate Non comparative study in pentamidinde relapse patients 25 0.75 mg/kg on alternate days (i.v) total 15 infusions 100 % [116]
Giri& Singh 1994 Amphotericin B deoxycholate Non comparative study in antimony relapse patients 100 0.75 mg/kg on alternate days (i.v) total 15 infusions 100 % [117]
Jha et. al. 1995 Amphotericin B deoxycholate Dose finding study in multidrug resistant patients 34 1.0 mg/kg/day on alternate days (i.v) total 10–15 infusions   [18]
Thakur et.al. 1996 Amphotericin B deoxycholate Randomized dose finding study 288 1.0 mg vs. 0.75 mg vs. 0.5 mg/kg/day for 20 days (i.v) 79–99 % [118]
Thakur et.al. 1998 Amphotericin B deoxycholate Randomized dose finding study 130 1.0 mg/kg/day for 20 days (i.v) vs. escalating dose for 5 days then 1.0 mg/kg/day for 43 days 99 % [119]
Thakur et.al. 1999 Amphotericin B deoxycholate Non comparative dose finding study 938 1.0 mg/kg/day for 20 days (i.v) 99.2 % [120]
Thakur & Ahmed 2001 Amphotericin B deoxycholate Non comparative study 309 1.0 mg/kg/day for 20 days (i.v) 95.8 % [22]
Thakur & Narayan 2004 Amphotericin B deoxycholate vs. SSG Randomized comparative study 60 AB: 1.0 mg/kg/day for 20 days (i.v) 46.6 and 100 % [121]
SSG: 20 vs. 10 mg Sbv+/kg/day for 28 days (i.m)
Singh et.al. 2010 Amphotericin B deoxycholate Randomized study in children’s 605 1.0 mg/kg/day for 15 days daily vs. alternate days (i.v) 100 % [122]
Thakur et.al. 1996 Liposomal Amphotericin B (LAB) Randomized open study of different schedule 30 2 mg/kg/day on day 1, 2, 3, 4, 5, 6 and 10 vs. days 1, 2, 3, 4 and 10 100 % [123]
Thakur et.al. 2001 Liposomal Amphotericin B vs. Amphotericin B deoxycholate Randomized trial 34 LAB: 15 mg/kg single dose (i.v) 100 % [28]
AB: 1.0 mg/kg/day for 20 days (i.v)
Sundar et.al. 2001 Liposomal Amphotericin B Open label dose finding study 91 5 mg/kg (single dose) vs. 1 mg/kg for 5 days (iv) 91 and 93 % [30]
Sundar et.al. 2002 Liposomal Amphotericin B Randomized double-blind dose ranging multicentre trial 84 0.75 mg/kg/days for 5 days (i.v) 89, 93 and 96 % [124]
Vs
1.5 mg/kg/days for 5 days (i.v)
Vs
3.0 mg/kg/days for 5 days (i.v)
Sundar et.al. 2003 Liposomal Amphotericin B Open label non comparative study 203 5.0 mg/kg/days for 5 days (i.v) 90 % [29]
Sundar et.al. 2004 Liposomal Amphotericin B vs. Amphotericin B deoxycholate Randomized comparative study 153 AB: 1.0 mg/kg/day for 15 dose on alternate days (i.v); LAB: 2.0 mg/kg/day for 5 days (i.v) Vs. Amphotericin B lipid complex 2 mg/kg/day for 5 days (i.v) 96, 96 and 92 % [125]
Sinha et.al. 2010 Liposomal Amphotericin B Observational cohort study 251 5.0 mg/kg/day (i.v) on 0,1,4, and 9 98.8 % [126]
Sundar et.al. 2010 Liposomal Amphotericin B vs. Amphotericin B deoxycholate Open label randomized controlled non inferiority study 412 LAB: 10.0 mg/kg/day (i.v) single dose 95.7 and 96.3 % [27]
AB: 1.0 mg/kg/day for 15 alternate dose (i.v)
Thakur et.al. 1984 Pentamidine Non-comparative study in SSG unresponsive patients 86 4 mg/kg/(i.m) for 15 dose (total dose 60 mg/kg) 93.4 % [127]
Thakur et.al. 1991 Pentamidine Randomized controlled comparative study 312 Group1: 4 mg/kg (i.v) 3 times weekly 78, 84 and 98 % respectively [128]
Group2: 4 mg/kg (i.v) 3 times weekly + SSG 20 mgSbv+/kg (i.m) daily for 20 days
Group3: 4 mg/kg (i.v) 3 times weekly until spleen were free from parasite + SSG 20 mgSbv+/kg (i.m) daily for 20 days
Mishra et.al. 1992 Pentamidine Randomized controlled comparative study 120 Pentamidine: 4 mg/kg (i.m) on alternate days (total 20 dose) 77 and 98 % [111]
AB: 0.5 mg.kg (i.v) on alternate days
Das et.al. 2001 Pentamidine Randomized controlled comparative study 158 Group1 : 2 mg/kg/day (i.m) on alternate days + oral allopurinol 15 mg/kg/day in 3 divided dose for 30 days 91.2 and 74.3 % [67]
Group 2 : 4 mg/kg/day (i.m) on alternate days for 30 days
Das et.al. 2009 Pentamidine Randomized controlled comparative study 82 Group 1: AB- 1 mg/kg/day alternate days for 15 days (i.v) 92 and 73 % [129]
Group 2: Pentamidine- 4 mg/kg/day alternate days (i.m)
Jha et.al. 1998 Paromomycin Randomized controlled comparative study 120 Group1: 12 mg/kg/day for 21 days (i.m) 76.7, 96.7, 96.7, and 63.3 % [130]
Group 2: 16 mg/kg/day for 21 days (i.m)
Group 3: 20 mg/kg/day for 21 days (i.m)
Group 4: SSG 20 mg Sbv+/kg/day for 30 days (i.m)
Sunder et.al. 2007 Paromomycin Randomized controlled phase III open label comparative study 667 Group 1 : Parmomycin 11 mg/kg/day for 21 days (i.m) 94.6 and 98.8 % [49]
Group 2 : AB 1 mg/kg/day for 30 days (i.v)
Sunder et.al. 2009 Paromomycin Randomized open label study 329 Group 1 : 11 mg/kg/day for 14 days (i.m) 82–92.8 % [131]
Group 2 : 11 mg/kg/day for 21 days (i.v)
Sinha et.al. 2011 Paromomycin Phase IV open label study 506 11 mg/kg/day for 21 days (i.m) 94.2 % [132]
Sundar et al. 1998 Miltefosine Phase-I/II safety and efficacy trial 30 50 mg-250 mg/day for 28 days (oral) 20–100 % [133]
Jha et al. 1999 Miltefosine Phase II randomized open label, dose finding 120 50 mg/day for 6 weeks; 50 mg/day for 1 week followed by 150 mg/day for 3 week; 100 mg/day for 4 week; 100 mg/day for 1 week followed by 150 mg/day for 3 week 93–97 % [134]
Sundar et al. 1999 Miltefosine Phase II comparative clinical trial 45 100-200 mg/day for 28 days 94–100 % [135]
Sundar et al. 2000 Miltefosine Phase II, Comparative study 54 100 mg/day for 14 days, 21 days or 28 days 88–100 % [136]
Sundar et al. 2002 Miltefosine Randomized open label comparative study 398 Miltefosine: 50-100 mg/day for 28 days 97–100 % [58]
AmB:1 mg/kg/day (i.v) for 15 days
Sundar et al. 2003 Miltefosine Open label phase II dose ranging study in childrens 39 1.5 or 2.5 mg/kg/day for 28 days 88–90 % [137]
Bhataacharya et al. 2004 Miletfosine Phase II trial in childrens 80 2.5 mg/kg/day for 28 days 94 % [138]
Singh et al. 2006 Miltefosine Prospective multicentric cross sectional study 125 Miltefosine: 2.5-100 mg/kg/day for 28 days 91.3–93.2 % [139]
AmB: 1 mg/kg/day (i.v) for 15 days
Bhattacharya et al. 2007 Miltefosine Phase IV open label single arm trial 2109 2.5–100 mg/kg/day for 28 days 93.6–96.6 % [140]
Sundar et al. 2012 Miltefosine Open label comparative study 567 50–100 mg/kg/day for 28 days 90.3 % [61]