Visceral LeishmaniasisPhase 2NCT00497601
A Phase II Study To Assess Safety and Efficacy Of Short-Course Regimens Of Amphotericin B Emulsion In Kala-Azar
A Phase 2 study testing Amphotericin B fat emulsion in visceral leishmaniasis, Amphotericin B fat emulsion and Amphotericin B in fat emulsion in people with Visceral Leishmaniasis, run by Banaras Hindu University at 1 site in India.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Visceral Leishmaniasis
- What is being tested?
- Amphotericin B fat emulsion in visceral leishmaniasis, Amphotericin B fat emulsion and Amphotericin B in fat emulsion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIndia
- Study dates
- Feb 2007to Jul 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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).
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.
Read the 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)
- Conditions
- Visceral Leishmaniasis
- Being tested
- Amphotericin B fat emulsion in visceral leishmaniasis, Amphotericin B fat emulsion, Amphotericin B in fat emulsion
- Keywords
- Visceral Leishmaniasis, Amphotericin B, Fat emulsion
- Medical subject headings
- Leishmaniasis, Visceral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amphotericin B fat emulsion in visceral leishmaniasisDrug
Also called Amphomul
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
Amphotericin B fat emulsionDrug
Also called Amphomul
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
Amphotericin B in fat emulsionDrug
Also called Amphomul
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
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Amphotericin B in fat emulsion (Amphomul) 7.5 mg/kg on day 1 and 3 Receives: Drug: Amphotericin B fat emulsion in visceral leishmaniasis; Drug: Amphotericin B fat emulsion; Drug: Amphotericin B in fat emulsion |
| B | Experimental | Amphotericin B in fat emulsion (Amphomul) 10 mg/kg on day 1 and 5 mg/kg on day 3 Receives: Drug: Amphotericin B fat emulsion in visceral leishmaniasis; Drug: Amphotericin B fat emulsion; Drug: Amphotericin B in fat emulsion |
| C | Experimental | Amphotericin B in fat emulsion (Amphomul) 12.5 mg/kg on day 1 and 2.5 mg/kg on day 3 Receives: Drug: Amphotericin B fat emulsion in visceral leishmaniasis; Drug: Amphotericin B fat emulsion; Drug: Amphotericin B in fat emulsion |
| D | Experimental | Amphotericin B in fat emulsion (Amphomul) 15 mg/kg in a single dose administration on day 1 Receives: Drug: Amphotericin B fat emulsion in visceral leishmaniasis; Drug: Amphotericin B fat emulsion; Drug: Amphotericin B in fat emulsion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical and parasitological cure at end of treatment and final cure (no relapse) at six months, no hematological, hepatic or renal toxicity
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2007 (estimated)
- Study startFeb 2007
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visceral LeishmaniasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Banaras Hindu University
- Sponsor type
- University, hospital or other
- Investigators
- Shyam Sundar, Principal investigator, Banaras Hindu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00497601
- Sponsor's protocol ID
- BSV-AMBE II-KA-706
- Status last verified
- Sep 2008
- First submitted
- 5 Jul 2007
- Last updated
- 12 Sep 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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).
- ClinicalTrials.gov ID
- NCT00497601
- Acronym / sponsor ID
- BSV-AMBE II-KA-706
- Conditions
- Visceral Leishmaniasis
- Keywords
- Visceral Leishmaniasis, Amphotericin B, Fat emulsion
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Banaras Hindu UniversityUniversity, hospital or other
- Study start
- Feb 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 6 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Amphotericin B fat emulsion in visceral leishmaniasis, Drug: Amphotericin B fat emulsion, Drug: Amphotericin B in fat emulsionAmphotericin B in fat emulsion (Amphomul) 7.5 mg/kg on day 1 and 3 |
| B | Experimental | Drug: Amphotericin B fat emulsion in visceral leishmaniasis, Drug: Amphotericin B fat emulsion, Drug: Amphotericin B in fat emulsionAmphotericin B in fat emulsion (Amphomul) 10 mg/kg on day 1 and 5 mg/kg on day 3 |
| C | Experimental | Drug: Amphotericin B fat emulsion in visceral leishmaniasis, Drug: Amphotericin B fat emulsion, Drug: Amphotericin B in fat emulsionAmphotericin B in fat emulsion (Amphomul) 12.5 mg/kg on day 1 and 2.5 mg/kg on day 3 |
| D | Experimental | Drug: Amphotericin B fat emulsion in visceral leishmaniasis, Drug: Amphotericin B fat emulsion, Drug: Amphotericin B in fat emulsionAmphotericin B in fat emulsion (Amphomul) 15 mg/kg in a single dose administration on day 1 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amphotericin B fat emulsion in visceral leishmaniasisAlso: AmphomulAmphotericin 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 | Drug | A, B, C, D |
| Amphotericin B fat emulsionAlso: AmphomulStarting 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 | Drug | A, B, C, D |
| Amphotericin B in fat emulsionAlso: AmphomulStarting 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 | Drug | A, B, C, D |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shyam Sundar principal investigator
Banaras Hindu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Amphotericin B fat emulsion in visceral leishmaniasis, Amphotericin B fat emulsion and Amphotericin B in fat emulsion in people with Visceral Leishmaniasis, run by Banaras Hindu University at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2008.