Status:
WITHDRAWN
SCH708980 With and Without AmBisome for Visceral Leishmaniasis
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Leishmaniasis
Effects of Immunotherapy
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
PHASE2
Brief Summary
Background: \- Visceral leishmaniasis (VL) is an infection caused by parasites carried by sand flies. The parasites cause fever, weight loss, and enlargement of the spleen and liver. They can also af...
Detailed Description
Visceral leishmaniasis (VL) or kala-azar is the most severe form of leishmaniasis, which can be fatal if left untreated. The majority of VL cases are found in resource-poor regions, including India (B...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Subjects (18 to 60 years of age) who meet the following criteria are eligible to enter the study:
- Newly diagnosed VL (within 4 to 5 days of screening) and confirmed by spleen or bone marrow aspirate.
- Clinical signs and symptoms compatible with VL: fever (\> 99 degrees F) over a 2-week duration, splenomegaly (palpable spleen below the costal margin), and weight loss.
- Biochemical and hematological test values:
- Hemoglobin \> 6.0g/100mL.
- WBC count \> 1.0 times 10(9)/L.
- Platelet count \> 40 times 10(9)/L.
- Aspartate aminotransferase (AST),alanine transaminase (ALT), and alkaline phosphatase \< 3 times the upper limit of normal.
- Prothrombin time (PT) \< 4 seconds above the control values.
- Serum creatinine levels within normal limits (males, 0.7 mg/dL - 1.1 mg/dL; females, 0.6 mg/dL - 0.9 mg/dL).
- Human immunodeficiency virus (HIV)-negative status.
- Willingness to be hospitalized for 30 days.
- Willingness to have samples stored.
- Negative serum pregnancy test result for women of childbearing potential.
- EXCLUSION CRITERIA:
- A history of intercurrent or concurrent diseases (e.g., chronic alcohol consumption or drug addiction; renal, hepatic, cardiovascular, or central nervous system disease; diabetes; tuberculosis or other infectious or major psychiatric diseases) that may introduce variables affecting the outcome of the study.
- Any condition which, in the investigator's opinion, may prevent the subject from completing the study and the subsequent follow-up.
- Previous treatment for VL within 45 days of study enrollment.
- A history of allergy or hypersensitivity to amphotericin B.
- Prior treatment failures with amphotericin B.
- Current use of other drugs with known anti-leishmanial activity (e.g., antimonials, pentamidine, paromomycin, miltefosine), azoles (e.g., fluconazole, ketoconazole or itraconazole), nephrotoxic drugs, immunosuppressive drugs, other investigational agents, immunomodulatory drugs.
- Breastfeeding women
- Vaccinations within 30 days prior to enrollment in the study.
- Exclusion of children:
- Subjects younger than 18 years of age will be excluded from the study because insufficient data are available supporting dosing with SCH708980 in adults to judge the potential risk in children.
- Exclusion of women:
- Pregnant and lactating women are excluded from the study because insufficient data are available supporting dosing with SCH708980 in these populations to judge the potential risk.
Exclusion
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01437020
Last Update
August 28 2013
Active Locations (2)
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1
Kala-Azar Medical Research Center (KAMRC), Rambag Road
Muzaffarpur, India
2
Banaras Hindu University
Varanasi, India