Back to resultsA Study Evaluating Sitamaquine Compared With Amphotericin B In The Treatment Of Visceral Leishmaniasis.
Primary Purpose
Leishmaniasis, Visceral
Status
Completed
Phase
Phase 2
Locations
India
Study Type
Interventional
Intervention
sitamaquine
Sponsored by
About this trial
This is an interventional treatment trial for Leishmaniasis, Visceral focused on measuring amphotericin B, safety, tolerability and pharmacokinetics of oral sitamaquine, Visceral leishmaniasis
Eligibility Criteria
Inclusion criteria:
- Clinical diagnosis of visceral leishmaniasis; symptoms and signs compatible with VL and diagnosis confirmed by visualisation of amastigotes in splenic aspirate or bone marrow.
- Written informed consent or witnessed oral consent.
- Willing to comply with the study visits and procedures.
- For female subjects, a negative urine pregnancy test at screening and before dosing and the subject agrees to use an established method of birth control (including abstinence).
Exclusion criteria:
- Past history of renal disease or impaired renal function at screening.
- History of any significant hepatic or biliary disease, or the following abnormal laboratory values at screening; hepatic dysfunction (AST or ALT 2.5 times upper limit of normal).
- Subjects with the following abnormal laboratory values; haemoglobin 6.5 g/dl, neutrophils <750/ mm3, platelets <50,000 / mm3, any clinically relevant abnormality identified on screening examination or clinical laboratories which would preclude the subject's safe participation in the study.
- History of cardiac disease, arrhythmias, conduction abnormalities or any clinically relevant abnormality identified on 12-lead ECG at screening.
Subjects suffering from a concomitant infection, blood disorder or any other serious underlying disease which would preclude evaluation of the subject's response to the study medication.
Methaemoglobin levels >5% at screening. G6PD deficiency.
- Positive HIV antibody, hepatitis B surface antigen or hepatitis C antibody at screening.
- Pregnant or nursing women; women of childbearing potential who are unwilling or unable to use an appropriate form of contraception, from prior to study medication administration until 2 weeks following the last dose of investigational product.
- Any contraindication to splenic aspirate (or bone marrow aspirate), including but not limited to PT prolonged >3 seconds longer than control or platelets <50,000 / mm3.
- Subjects with a known hypersensitivity reaction to 8-aminoquinolines (e.g. primaquine) or any of the investigational product excipients.
- Treatment with an established antileishmanial chemotherapeutic agent within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication.
- Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication.
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
Outcomes
Primary Outcome Measures
Area under the concentration-time curve over the dosing interval AUC(0-tau) for sitamaquine
AUC is defined as the area under the concentration-time curve from 0 to last quantifiable concentration (AUC 0-tau). AUC is a measure of exposure. Blood samples for determination of plasma concentrations of sitamaquine was obtained at the following time points on days 1, 10 and 21: immediately pre-dose, and at 1, 2, 3, 4, 6, 10, 16 hours post dose. An additional sample was taken on Day 23 and Day 24 to approximate 48 hours and 72 hours post last dose on Day 21. Only those participants with data available at the specified time points were analyzed.
Maximum plasma concentration (Cmax) for sitamaquine
Cmax was defined as the maximum concentration of sitamaquine. Blood samples for determination of plasma concentrations of sitamaquine was obtained at the following time points on days 1, 10 and 21: immediately pre-dose, and at 1, 2, 3, 4, 6, 10, 16 hours. An additional sample was taken on Day 23 and Day 24 to approximate 48 hours and 72 hours post last dose on Day 21.
Time to maximum observed plasma concentration (tmax) for sitamaquine
Tmax is defined as the time to peak concentration from initiation of sitamaquine dosing. Blood samples for determination of plasma concentrations of sitamaquine was obtained at the following time points on days 1, 10 and 21: immediately pre-dose, and at 1, 2, 3, 4, 6, 10, 16 hours post dose. An additional sample was taken on Day 23 and Day 24 to approximate 48 hours and 72 hours post last dose on Day 21.
Accumulation ratio for sitamaquine
Point estimate was the ratio of adjusted geometric means between repeat dosing days (Day 21 or Day 10) and single dose day (Day 1). An evaluation on the accumulation rate was based upon the comparison of AUC(0-24) values after repeated dosing to the values from the first dose on day 1. Blood samples for determination of plasma concentrations of sitamaquine was obtained at the following time points on days 1, 10 and 21: immediately pre-dose, and at 1, 2, 3, 4, 6, 10, 16 hours post dose. An additional sample was taken on Day 23 and Day 24 to approximate 48 hours and 72 hours post last dose on Day 21. Individual observed accumulation ratios on Day 10 were calculated by dividing AUC (0-tau) on Day 10 by AUC (0-tau) on Day 1. A similar formula was applied to the accumulation ratio on Day 21.
Secondary Outcome Measures
Number of participants with adverse events(AEs) and serious adverse events(SAEs)
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Data for on-treatment AEs have been reported,
Number of participants with abnormal 12-lead Electrocardiogram (ECG) values
Data for abnormal findings have been reported at Day 22 for Sitamaquine and Day 31 for Amphotericin B. All ECGs were collected in the supine position with the electrodes placed in the standard positions, 4 hours after dosing on drug administration days, and prior to blood collection or pulse rate measurement.
Number of participants with abnormal echocardiography results
2-D echocardiograms were performed at screening (all participants), Days 22 and 49 (sitamaquine only) and days 31 and 58 (amphotericin B only). All echocardiograms were obtained after the participant has rested in a semi-supine position for at least 10 minutes. All echocardiograms were stored electronically (e.g video home system [VHS] tape, optical drive, etc.). Ejection fraction was estimated using the modified Simpson's rule method. Data for number of participants with abnormal echocardiography results have been reported.
Change from Baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP) at Day 180
Blood pressure (SBP and DBP) was recorded after the participant had rested in a semi-supine position for at least 10 minutes. Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was Day 1 pre-dose.
Change from Baseline in heart rate
Heart rate was recorded after the participant had rested in a semi-supine position for at least 10 minutes. Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was Day 1 pre-dose.
Change from Baseline in body temperature
Body temperature was recorded after the participant had rested in a semi-supine position for at least 10 minutes. Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was Day 1 pre-dose.
Change from Baseline in body weight
Body weight was recorded after the participant had rested in a semi-supine position for at least 10 minutes. Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was Day 1 pre-dose.
Number of participants with abnormal hematology values at the end of study (Day 180)
Data for number of participants with hematology abnormalities for the end of study (Day 180) is presented. Hematology abnormalities were classified using Common Terminology Criteria for Adverse Events (CTCAE) v3.0 Grades and grade 3 ranges are as follows (selected): Hemoglobin (grams per liter [G/L])- <80 - 65; Total Neutrophils (gram international units per liter[GI/L])- <1.0 - 0.5 x 10^9/L; Platelet count(GI/L) <50.0- 25.0 x 10^9 /L; White Blood Cell (WBC) (GI/L)- <2.0 - 1.0 x 10^9 /L. Data only for categories with values have been presented.
Number of participants with abnormal clinical chemistry values at the end of study (Day 180)
Aspartate Amino Transferase (AST) ([international units per liter [IU/L])- >5.0 - 20.0 x upper limit of normal (ULN); Albumin(G/L)- <20 g/dL; Alkaline Phosphatase(IU/L)- >5.0 - 20.0 x ULN; Alanine Amino Transferase(IU/L)- >5.0 - 20.0 x ULN; Total Bilirubin( micromoles per liter [µMOL/L])- >3.0 - 10.0 x ULN; Urea(millimoles per liter [MMOL/L])- 5.1 - 10 x ULN; Cholesterol (MMOL/L) - >10.34 - 12.92; Creatine Kinase MB (microgram per liter[µ/L])->5 x ULN - 10 x ULN; Creatinine Clearance(milliliter per minute [mL/min])- <25% lower limit of normal (LLN); Creatinine(µMOL/L)- >3.0 - 6.0 x ULN; Gamma Glutamyl Transferase(IU/L)- >5.0 - 20.0 x ULN; Potassium(MMOL/L)- >6.0 - 7.0(high) and <3.0 - 2.5 (low); Sodium(MMOL/L)- >155 - 160; Sodium(MMOL/L)- <130 - 120; Triglycerides(MMOL/L)- >5.0 - 10.0 x ULN. Data only for categories with values have been presented.
Number of participants with Initial parasitological cure (28 days)
Initial parasitological cure was defined as a parasite-negative splenic aspirate at completion of treatment or, if the leishmania index (a quantitative assessment of parasites in the splenic aspirate) was +1, a parasite-negative result at the repeat splenic aspirate 28 days later.
Number of participants with Final parasitological cure (6 months)
Final clinical cure was defined as initial parasitological cure (initial parasitological cure was defined as a parasite-negative splenic aspirate at completion of treatment or, if the leishmania index [a quantitative assessment of parasites in the splenic aspirate] was +1, a parasite-negative result at the repeat splenic aspirate 28 days later) and no evidence of relapse at 6 months.
Terminal elimination half-life (t1/2) for sitamaquine
Half life is defined as the period of time required for the amount of drug in the body to be reduced by half. Blood samples for determination of plasma concentrations of sitamaquine was obtained at the following time points on days 1, 10 and 21: immediately pre-dose, and at 1, 2, 3, 4, 6, 10, 16 hours post dose. An additional sample was taken on Day 23 and Day 24 to approximate 48 hours and 72 hours post last dose on Day 21.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00381394
Brief Title
A Study Evaluating Sitamaquine Compared With Amphotericin B In The Treatment Of Visceral Leishmaniasis.
Official Title
A Phase II, Multi-centre, Open-label, Randomised Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Oral Sitamaquine Compared With Amphotericin B in the Treatment of Visceral Leishmaniasis Caused by L. Donovani in Endemic Areas.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
August 4, 2006 (Actual)
Primary Completion Date
September 14, 2007 (Actual)
Study Completion Date
September 14, 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Sitamaquine is an 8-aminoquinoline which is being developed as an oral treatment for visceral leishmaniasis (VL). Pre-clinical and subsequent clinical investigations have demonstrated oral efficacy against Leishmania donovani. The purposes of this study are to characterise the pharmacokinetic profile of sitamaquine, administered orally, and to determine if the pharmacokinetic profile is affected by administration with food. The study is also designed to further characterise the safety and tolerability of sitamaquine compared with amphotericin B, particularly in reference to renal, hepatic and cardiac adverse events, prior to initiation of phase III studies. Finally the study will investigate the efficacy of a 21 day treatment course. Previous studies have used 28 days dosing, but parasitological evidence from one study suggests that shorter courses may be effective.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leishmaniasis, Visceral
Keywords
amphotericin B, safety, tolerability and pharmacokinetics of oral sitamaquine, Visceral leishmaniasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
61 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
sitamaquine
Primary Outcome Measure Information:
Title
Area under the concentration-time curve over the dosing interval AUC(0-tau) for sitamaquine
Description
AUC is defined as the area under the concentration-time curve from 0 to last quantifiable concentration (AUC 0-tau). AUC is a measure of exposure. Blood samples for determination of plasma concentrations of sitamaquine was obtained at the following time points on days 1, 10 and 21: immediately pre-dose, and at 1, 2, 3, 4, 6, 10, 16 hours post dose. An additional sample was taken on Day 23 and Day 24 to approximate 48 hours and 72 hours post last dose on Day 21. Only those participants with data available at the specified time points were analyzed.
Time Frame
At Day 1, 10 and 21: immediately pre-dose, and at 1, 2, 3, 4, 6, 10, 16 hours post dose
Title
Maximum plasma concentration (Cmax) for sitamaquine
Description
Cmax was defined as the maximum concentration of sitamaquine. Blood samples for determination of plasma concentrations of sitamaquine was obtained at the following time points on days 1, 10 and 21: immediately pre-dose, and at 1, 2, 3, 4, 6, 10, 16 hours. An additional sample was taken on Day 23 and Day 24 to approximate 48 hours and 72 hours post last dose on Day 21.
Time Frame
At Day 1, 10 and 21: immediately pre-dose, and at 1, 2, 3, 4, 6, 10, 16 hours post dose.
Title
Time to maximum observed plasma concentration (tmax) for sitamaquine
Description
Tmax is defined as the time to peak concentration from initiation of sitamaquine dosing. Blood samples for determination of plasma concentrations of sitamaquine was obtained at the following time points on days 1, 10 and 21: immediately pre-dose, and at 1, 2, 3, 4, 6, 10, 16 hours post dose. An additional sample was taken on Day 23 and Day 24 to approximate 48 hours and 72 hours post last dose on Day 21.
Time Frame
At Day 1, 10 and 21: immediately pre-dose, and at 1, 2, 3, 4, 6, 10, 16 hours post dose.
Title
Accumulation ratio for sitamaquine
Description
Point estimate was the ratio of adjusted geometric means between repeat dosing days (Day 21 or Day 10) and single dose day (Day 1). An evaluation on the accumulation rate was based upon the comparison of AUC(0-24) values after repeated dosing to the values from the first dose on day 1. Blood samples for determination of plasma concentrations of sitamaquine was obtained at the following time points on days 1, 10 and 21: immediately pre-dose, and at 1, 2, 3, 4, 6, 10, 16 hours post dose. An additional sample was taken on Day 23 and Day 24 to approximate 48 hours and 72 hours post last dose on Day 21. Individual observed accumulation ratios on Day 10 were calculated by dividing AUC (0-tau) on Day 10 by AUC (0-tau) on Day 1. A similar formula was applied to the accumulation ratio on Day 21.
Time Frame
At Day 1, 10 and 21: immediately pre-dose, and at 1, 2, 3, 4, 6, 10, 16 hours post dose
Secondary Outcome Measure Information:
Title
Number of participants with adverse events(AEs) and serious adverse events(SAEs)
Description
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Data for on-treatment AEs have been reported,
Time Frame
Up to 180 days
Title
Number of participants with abnormal 12-lead Electrocardiogram (ECG) values
Description
Data for abnormal findings have been reported at Day 22 for Sitamaquine and Day 31 for Amphotericin B. All ECGs were collected in the supine position with the electrodes placed in the standard positions, 4 hours after dosing on drug administration days, and prior to blood collection or pulse rate measurement.
Time Frame
At Day 22 for Sitamaquine and Day 31 for Amphotericin B
Title
Number of participants with abnormal echocardiography results
Description
2-D echocardiograms were performed at screening (all participants), Days 22 and 49 (sitamaquine only) and days 31 and 58 (amphotericin B only). All echocardiograms were obtained after the participant has rested in a semi-supine position for at least 10 minutes. All echocardiograms were stored electronically (e.g video home system [VHS] tape, optical drive, etc.). Ejection fraction was estimated using the modified Simpson's rule method. Data for number of participants with abnormal echocardiography results have been reported.
Time Frame
Up to Day 22 and 49 (sitamaquine only) and Day 31 and 58 (amphotericin B only)
Title
Change from Baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP) at Day 180
Description
Blood pressure (SBP and DBP) was recorded after the participant had rested in a semi-supine position for at least 10 minutes. Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was Day 1 pre-dose.
Time Frame
Baseline (Day 1 pre-dose) and Day 180
Title
Change from Baseline in heart rate
Description
Heart rate was recorded after the participant had rested in a semi-supine position for at least 10 minutes. Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was Day 1 pre-dose.
Time Frame
Baseline (Day 1 pre-dose) and Day 180
Title
Change from Baseline in body temperature
Description
Body temperature was recorded after the participant had rested in a semi-supine position for at least 10 minutes. Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was Day 1 pre-dose.
Time Frame
Baseline (Day 1 pre-dose) and Day 180
Title
Change from Baseline in body weight
Description
Body weight was recorded after the participant had rested in a semi-supine position for at least 10 minutes. Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was Day 1 pre-dose.
Time Frame
Baseline (Day 1 pre-dose) and Day 49 for Sitamaquine and Day 58 for Amphotericin B
Title
Number of participants with abnormal hematology values at the end of study (Day 180)
Description
Data for number of participants with hematology abnormalities for the end of study (Day 180) is presented. Hematology abnormalities were classified using Common Terminology Criteria for Adverse Events (CTCAE) v3.0 Grades and grade 3 ranges are as follows (selected): Hemoglobin (grams per liter [G/L])- <80 - 65; Total Neutrophils (gram international units per liter[GI/L])- <1.0 - 0.5 x 10^9/L; Platelet count(GI/L) <50.0- 25.0 x 10^9 /L; White Blood Cell (WBC) (GI/L)- <2.0 - 1.0 x 10^9 /L. Data only for categories with values have been presented.
Time Frame
Day 180
Title
Number of participants with abnormal clinical chemistry values at the end of study (Day 180)
Description
Aspartate Amino Transferase (AST) ([international units per liter [IU/L])- >5.0 - 20.0 x upper limit of normal (ULN); Albumin(G/L)- <20 g/dL; Alkaline Phosphatase(IU/L)- >5.0 - 20.0 x ULN; Alanine Amino Transferase(IU/L)- >5.0 - 20.0 x ULN; Total Bilirubin( micromoles per liter [µMOL/L])- >3.0 - 10.0 x ULN; Urea(millimoles per liter [MMOL/L])- 5.1 - 10 x ULN; Cholesterol (MMOL/L) - >10.34 - 12.92; Creatine Kinase MB (microgram per liter[µ/L])->5 x ULN - 10 x ULN; Creatinine Clearance(milliliter per minute [mL/min])- <25% lower limit of normal (LLN); Creatinine(µMOL/L)- >3.0 - 6.0 x ULN; Gamma Glutamyl Transferase(IU/L)- >5.0 - 20.0 x ULN; Potassium(MMOL/L)- >6.0 - 7.0(high) and <3.0 - 2.5 (low); Sodium(MMOL/L)- >155 - 160; Sodium(MMOL/L)- <130 - 120; Triglycerides(MMOL/L)- >5.0 - 10.0 x ULN. Data only for categories with values have been presented.
Time Frame
Day 180
Title
Number of participants with Initial parasitological cure (28 days)
Description
Initial parasitological cure was defined as a parasite-negative splenic aspirate at completion of treatment or, if the leishmania index (a quantitative assessment of parasites in the splenic aspirate) was +1, a parasite-negative result at the repeat splenic aspirate 28 days later.
Time Frame
Up to 28 days
Title
Number of participants with Final parasitological cure (6 months)
Description
Final clinical cure was defined as initial parasitological cure (initial parasitological cure was defined as a parasite-negative splenic aspirate at completion of treatment or, if the leishmania index [a quantitative assessment of parasites in the splenic aspirate] was +1, a parasite-negative result at the repeat splenic aspirate 28 days later) and no evidence of relapse at 6 months.
Time Frame
Up to 180 days
Title
Terminal elimination half-life (t1/2) for sitamaquine
Description
Half life is defined as the period of time required for the amount of drug in the body to be reduced by half. Blood samples for determination of plasma concentrations of sitamaquine was obtained at the following time points on days 1, 10 and 21: immediately pre-dose, and at 1, 2, 3, 4, 6, 10, 16 hours post dose. An additional sample was taken on Day 23 and Day 24 to approximate 48 hours and 72 hours post last dose on Day 21.
Time Frame
At Day 1, 10 and 21: immediately pre-dose, and at 1, 2, 3, 4, 6, 10, 16 hours post dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Clinical diagnosis of visceral leishmaniasis; symptoms and signs compatible with VL and diagnosis confirmed by visualisation of amastigotes in splenic aspirate or bone marrow.
Written informed consent or witnessed oral consent.
Willing to comply with the study visits and procedures.
For female subjects, a negative urine pregnancy test at screening and before dosing and the subject agrees to use an established method of birth control (including abstinence).
Exclusion criteria:
Past history of renal disease or impaired renal function at screening.
History of any significant hepatic or biliary disease, or the following abnormal laboratory values at screening; hepatic dysfunction (AST or ALT 2.5 times upper limit of normal).
Subjects with the following abnormal laboratory values; haemoglobin 6.5 g/dl, neutrophils <750/ mm3, platelets <50,000 / mm3, any clinically relevant abnormality identified on screening examination or clinical laboratories which would preclude the subject's safe participation in the study.
History of cardiac disease, arrhythmias, conduction abnormalities or any clinically relevant abnormality identified on 12-lead ECG at screening.
Subjects suffering from a concomitant infection, blood disorder or any other serious underlying disease which would preclude evaluation of the subject's response to the study medication.
Methaemoglobin levels >5% at screening. G6PD deficiency.
Positive HIV antibody, hepatitis B surface antigen or hepatitis C antibody at screening.
Pregnant or nursing women; women of childbearing potential who are unwilling or unable to use an appropriate form of contraception, from prior to study medication administration until 2 weeks following the last dose of investigational product.
Any contraindication to splenic aspirate (or bone marrow aspirate), including but not limited to PT prolonged >3 seconds longer than control or platelets <50,000 / mm3.
Subjects with a known hypersensitivity reaction to 8-aminoquinolines (e.g. primaquine) or any of the investigational product excipients.
Treatment with an established antileishmanial chemotherapeutic agent within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication.
Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Muzaffarpur
ZIP/Postal Code
842001
Country
India
Facility Name
GSK Investigational Site
City
Muzaffarpur
Country
India
Facility Name
GSK Investigational Site
City
Patna
ZIP/Postal Code
800007
Country
India
12. IPD Sharing Statement
Citations:
PubMed Identifier
21633025
Citation
Sundar S, Sinha PK, Dixon SA, Buckley R, Miller AK, Mohamed K, Al-Banna M. Pharmacokinetics of oral sitamaquine taken with or without food and safety and efficacy for treatment of visceral leishmaniais: a randomized study in Bihar, India. Am J Trop Med Hyg. 2011 Jun;84(6):892-900. doi: 10.4269/ajtmh.2011.10-0409.
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A Study Evaluating Sitamaquine Compared With Amphotericin B In The Treatment Of Visceral Leishmaniasis.
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