A Phase II Study To Assess Safety and Efficacy Of Short-Course Regimens Of Amphotericin B Emulsion In Kala-Azar

This study has been completed.
Sponsor:
Information provided by:
Banaras Hindu University
ClinicalTrials.gov Identifier:
NCT00497601
First received: July 5, 2007
Last updated: September 11, 2008
Last verified: September 2008
  Purpose

The purpose of this study is:

  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.

Condition Intervention Phase
Visceral Leishmaniasis
Drug: Amphotericin B fat emulsion in visceral leishmaniasis
Drug: Amphotericin B fat emulsion
Drug: Amphotericin B in fat emulsion
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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).

Resource links provided by NLM:


Further study details as provided by Banaras Hindu University:

Primary Outcome Measures:
  • Clinical and parasitological cure at end of treatment and final cure (no relapse) at six months, no hematological, hepatic or renal toxicity [ Time Frame: one year ]

Enrollment: 60
Study Start Date: February 2007
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Amphotericin B in fat emulsion (Amphomul) 7.5 mg/kg on day 1 and 3
Drug: Amphotericin B fat emulsion in visceral leishmaniasis
Amphotericin B in fat emulsion (Amphomul) 7.5 mg/kg on day 1 & 3 in group A Amphotericin B in fat emulsion (Amphomul) 10 & 5 mg/kg on day 1 & 3 in group B Amphotericin B in fat emulsion (Amphomul) 12.5 & 2.5 mg/kg on day 1 & 3 in group C Amphotericin B in fat emulsion (Amphomul) 15 mg/kg on day 1 in group D
Other Name: Amphomul
Drug: Amphotericin B fat emulsion
Starting with 7.5 mg/kg on day 1 and 3, 10 and 5 mg/kg on day 1 and 3, 12.5 and 2.5 mg/kg on day 1 and 3 and finally 15 mg/kg on day 1
Other Name: Amphomul
Drug: Amphotericin B in fat emulsion
Starting with 7.5 mg/kg on day 1 and 3, 10 and 5 mg/kg on day 1 and 3, 12.5 and 2.5 mg/kg on day 1 and 3 and finally 15 mg/kg on day 1
Other Name: Amphomul
Experimental: B
Amphotericin B in fat emulsion (Amphomul) 10 mg/kg on day 1 and 5 mg/kg on day 3
Drug: Amphotericin B fat emulsion in visceral leishmaniasis
Amphotericin B in fat emulsion (Amphomul) 7.5 mg/kg on day 1 & 3 in group A Amphotericin B in fat emulsion (Amphomul) 10 & 5 mg/kg on day 1 & 3 in group B Amphotericin B in fat emulsion (Amphomul) 12.5 & 2.5 mg/kg on day 1 & 3 in group C Amphotericin B in fat emulsion (Amphomul) 15 mg/kg on day 1 in group D
Other Name: Amphomul
Drug: Amphotericin B fat emulsion
Starting with 7.5 mg/kg on day 1 and 3, 10 and 5 mg/kg on day 1 and 3, 12.5 and 2.5 mg/kg on day 1 and 3 and finally 15 mg/kg on day 1
Other Name: Amphomul
Drug: Amphotericin B in fat emulsion
Starting with 7.5 mg/kg on day 1 and 3, 10 and 5 mg/kg on day 1 and 3, 12.5 and 2.5 mg/kg on day 1 and 3 and finally 15 mg/kg on day 1
Other Name: Amphomul
Experimental: C
Amphotericin B in fat emulsion (Amphomul) 12.5 mg/kg on day 1 and 2.5 mg/kg on day 3
Drug: Amphotericin B fat emulsion in visceral leishmaniasis
Amphotericin B in fat emulsion (Amphomul) 7.5 mg/kg on day 1 & 3 in group A Amphotericin B in fat emulsion (Amphomul) 10 & 5 mg/kg on day 1 & 3 in group B Amphotericin B in fat emulsion (Amphomul) 12.5 & 2.5 mg/kg on day 1 & 3 in group C Amphotericin B in fat emulsion (Amphomul) 15 mg/kg on day 1 in group D
Other Name: Amphomul
Drug: Amphotericin B fat emulsion
Starting with 7.5 mg/kg on day 1 and 3, 10 and 5 mg/kg on day 1 and 3, 12.5 and 2.5 mg/kg on day 1 and 3 and finally 15 mg/kg on day 1
Other Name: Amphomul
Drug: Amphotericin B in fat emulsion
Starting with 7.5 mg/kg on day 1 and 3, 10 and 5 mg/kg on day 1 and 3, 12.5 and 2.5 mg/kg on day 1 and 3 and finally 15 mg/kg on day 1
Other Name: Amphomul
Experimental: D
Amphotericin B in fat emulsion (Amphomul) 15 mg/kg in a single dose administration on day 1
Drug: Amphotericin B fat emulsion in visceral leishmaniasis
Amphotericin B in fat emulsion (Amphomul) 7.5 mg/kg on day 1 & 3 in group A Amphotericin B in fat emulsion (Amphomul) 10 & 5 mg/kg on day 1 & 3 in group B Amphotericin B in fat emulsion (Amphomul) 12.5 & 2.5 mg/kg on day 1 & 3 in group C Amphotericin B in fat emulsion (Amphomul) 15 mg/kg on day 1 in group D
Other Name: Amphomul
Drug: Amphotericin B fat emulsion
Starting with 7.5 mg/kg on day 1 and 3, 10 and 5 mg/kg on day 1 and 3, 12.5 and 2.5 mg/kg on day 1 and 3 and finally 15 mg/kg on day 1
Other Name: Amphomul
Drug: Amphotericin B in fat emulsion
Starting with 7.5 mg/kg on day 1 and 3, 10 and 5 mg/kg on day 1 and 3, 12.5 and 2.5 mg/kg on day 1 and 3 and finally 15 mg/kg on day 1
Other Name: Amphomul

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 < 6 gm/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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00497601

Locations
India
Kala-azar Medical Research Center
Muzaffarpur, Bihar, India, 842001
Sponsors and Collaborators
Banaras Hindu University
Investigators
Principal Investigator: Shyam Sundar Banaras Hindu University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00497601     History of Changes
Other Study ID Numbers: BSV-AMBE II-KA-706
Study First Received: July 5, 2007
Last Updated: September 11, 2008
Health Authority: India: Ministry of Health

Keywords provided by Banaras Hindu University:
Visceral Leishmaniasis
Amphotericin B
Fat emulsion

Additional relevant MeSH terms:
Leishmaniasis
Leishmaniasis, Visceral
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases
Amphotericin B
Liposomal amphotericin B
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Bacterial Agents
Antifungal Agents

ClinicalTrials.gov processed this record on September 16, 2014