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

Singh, Om Prakash; Singh, Bhawana; Chakravarty, Jaya; Sundar, Shyam

doi:10.1186/s40249-016-0112-2

Infectious Diseases of Poverty

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]
Mishra et al.	1992	Amphotericin B deoxycholate vs. Pentamidicine		120	Pentamidinine: 4 mg/kg on alternate days for 20 injections (i.m)	77–98 %	[111]
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]
Thakur et al.	1993	Amphotericin B deoxycholate vs. Pentavalent antimonials	Randomized controlled comparative trial	150	SSG: 20 vs. 10 mg Sbv+/kg/day for 30 days (i.m)	80–100 %	[112]
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]
Mishra et al.	1994	Amphotericin B deoxycholate vs. Pentavalent antimonials	Randomized controlled comparative trial	80	SSG: 20 mg Sbv+/kg/day for 40 days (i.m)	62–100 %	[113]
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]
Thakur & Narayan	2004	Amphotericin B deoxycholate vs. SSG	Randomized comparative study	60	SSG: 20 vs. 10 mg Sbv+/kg/day for 28 days (i.m)	46.6 and 100 %	[121]
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]
Thakur et.al.	2001	Liposomal Amphotericin B vs. Amphotericin B deoxycholate	Randomized trial	34	AB: 1.0 mg/kg/day for 20 days (i.v)	100 %	[28]
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]
Sundar et.al.	2010	Liposomal Amphotericin B vs. Amphotericin B deoxycholate	Open label randomized controlled non inferiority study	412	AB: 1.0 mg/kg/day for 15 alternate dose (i.v)	95.7 and 96.3 %	[27]
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]
Mishra et.al.	1992	Pentamidine	Randomized controlled comparative study	120	AB: 0.5 mg.kg (i.v) on alternate days	77 and 98 %	[111]
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]
Das et.al.	2001	Pentamidine	Randomized controlled comparative study	158	Group 2 : 4 mg/kg/day (i.m) on alternate days for 30 days	91.2 and 74.3 %	[67]
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]
Das et.al.	2009	Pentamidine	Randomized controlled comparative study	82	Group 2: Pentamidine- 4 mg/kg/day alternate days (i.m)	92 and 73 %	[129]
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]
Sunder et.al.	2007	Paromomycin		667	Group 2 : AB 1 mg/kg/day for 30 days (i.v)	94.6 and 98.8 %	[49]
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]
Sunder et.al.	2009	Paromomycin	Randomized open label study	329	Group 2 : 11 mg/kg/day for 21 days (i.v)	82–92.8 %	[131]
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]
Sundar et al.	2002	Miltefosine	Randomized open label comparative study	398	AmB:1 mg/kg/day (i.v) for 15 days	97–100 %	[58]
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]
Singh et al.	2006	Miltefosine	Prospective multicentric cross sectional study	125	AmB: 1 mg/kg/day (i.v) for 15 days	91.3–93.2 %	[139]
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]

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