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:
Banaras Hindu University
Information provided by:
Banaras Hindu University
ClinicalTrials.gov Identifier:
NCT00497601
First received: July 5, 2007
Last updated: September 11, 2008
Last verified: September 2008
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Purpose
The purpose of this study is:
- 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.
- 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:
- 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.
- 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:
- Male or female subjects between 18 years and 65 years of age (both inclusive).
- Subject/subject's legally acceptable representative is willing and able to give written informed consent to participate in the study.
- 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:
- Subjects with past history of treatment with Amphotericin B for Kala-azar.
- Subjects positive for HIV infection.
- Concomitant life threatening or serious disease.
- Concurrent malaria (malarial parasite test to be negative prior to study treatment administration), tuberculosis or bacterial pneumonia.
- Haemoglobin < 6 gm/dl, total leukocyte count < 1,500/cmm, platelet count < 50,000/cmm
- 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).
- Pregnant or nursing women.
- Known hypersensitivity to Amphotericin B or inactive ingredients of study drug formulation.
- Subjects receiving any of the medications prohibited by the study protocol.
- 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.
- Simultaneous participation in another trial or received any investigational product < 30 days prior to enrolment.
Contacts and Locations 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 Antifungal Agents Anti-Bacterial Agents |
ClinicalTrials.gov processed this record on May 21, 2013