Status:
COMPLETED
A Study Evaluating Sitamaquine Compared With Amphotericin B In The Treatment Of Visceral Leishmaniasis.
Lead Sponsor:
GlaxoSmithKline
Conditions:
Leishmaniasis, Visceral
Eligibility:
All Genders
16-50 years
Phase:
PHASE2
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 ag...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
August 4 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 14 2007
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT00381394
Start Date
August 4 2006
End Date
September 14 2007
Last Update
September 18 2017
Active Locations (3)
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1
GSK Investigational Site
Muzaffarpur, India, 842001
2
GSK Investigational Site
Muzaffarpur, India
3
GSK Investigational Site
Patna, India, 800007