A Phase II Study To Assess Safety and Efficacy Of Short-Course Regimens Of Amphotericin B Emulsion In Kala-Azar
Information source: Banaras Hindu University
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Visceral Leishmaniasis
Intervention: Amphotericin B fat emulsion in visceral leishmaniasis (Drug); Amphotericin B fat emulsion (Drug); Amphotericin B in fat emulsion (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Banaras Hindu University Official(s) and/or principal investigator(s):
Shyam Sundar, Principal Investigator, Affiliation: Banaras Hindu University
Summary
1. To evaluate the Safety and Efficacy of four different short-course regimens of
Amphotericin B emulsion in treatment of Kala-azar (visceral leishmaniasis) subjects who
are either treatment naive or treatment resistant to other antileishmanial drugs except
amphotericin B containing preparations.
2. To assess the safety and efficacy of single-bolus infusion of Amphotericin B emulsion in
treatment of Kala-azar.
Clinical Details
Official title: A Prospective, Single Center, Open-Label, Dose-Escalation Phase II Study To Assess Safety and Efficacy Of Short-Course Regimens Of Amphotericin B Emulsion In Treatment Naïve Or Resistant Cases Of Visceral Leishmaniasis (Kala-Azar).
Study design: Treatment, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Clinical and parasitological cure at end of treatment and final cure (no relapse) at six months, no hematological, hepatic or renal toxicity
Detailed description:
1. To evaluate the Safety and Efficacy of four different short-course regimens of
Amphotericin B emulsion in treatment of Kala-azar (visceral leishmaniasis) subjects who
are either treatment naive or treatment resistant to other antileishmanial drugs except
amphotericin B containing preparations.
2. To assess the safety and efficacy of single-bolus infusion of Amphotericin B emulsion in
treatment of Kala-azar.
Subjects will be administered the study drug in either of the following four dose levels in
an ascending manner, starting with the first dosage regimen:
- 7. 5 mg/kg on day 1 and day3 (Regimen 1)
- 10 mg/kg on day 1, followed by 5 mg/kg on day 3 (Regimen 2)
- 12. 5 mg/kg on day 1, followed by 2. 5 mg/kg on day 3 (Regimen 3)
- Single-bolus infusion of 15 mg/kg over 2-4 hours on day 1 (Regimen 4)
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Male or female subjects between 18 years and 65 years of age (both inclusive).
2. Subject/subject's legally acceptable representative is willing and able to give
written informed consent to participate in the study.
3. Treatment naive subjects having symptoms and/or signs of visceral leishmaniasis with
parasitological confirmation of Kala-azar (by splenic or bone marrow aspirate smear
examination).
If subjects are previously treated with other antileishmanial drugs except amphotericin B
containing preparations, they will be enrolled in the study only after clinical and
parasitological evidence that the disease is unresponsive to adequate treatment with other
drugs, and after an appropriate wash out period
Exclusion Criteria:
1. Subjects with past history of treatment with Amphotericin B for Kala-azar.
2. Subjects positive for HIV infection.
3. Concomitant life threatening or serious disease.
4. Concurrent malaria (malarial parasite test to be negative prior to study treatment
administration), tuberculosis or bacterial pneumonia.
5. Haemoglobin <6gm/dl, total leukocyte count <1,500/cmm, platelet count <50,000/cmm
6. Abnormal liver and renal functions (BUN and serum creatinine >1. 5 times upper limit of
normal (ULN), AST/ALT >2. 5 times ULN, and bilirubin >1. 5 times ULN).
7. Pregnant or nursing women.#
8. Known hypersensitivity to Amphotericin B or inactive ingredients of study drug
formulation.
9. Subjects receiving any of the medications prohibited by the study protocol.
10. Evidence of significant haematological, cardiac, hepatic, renal, respiratory,
neurological or metabolic disease or any condition which, in the opinion of the
investigator, might interfere with the evaluation of the study objectives.
11. Simultaneous participation in another trial or received any investigational product
<30 days prior to enrolment.
Locations and Contacts
Kala-azar Medical Research Center, Muzaffarpur, Bihar 842001, India
Additional Information
Starting date: February 2007
Last updated: September 4, 2007
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