Visceral LeishmaniasisPhase 2NCT00371995
Short Course of Miltefosine and Liposomal Amphotericin B for Kala-azar
A Phase 2 study testing Liposomal amphotericin B and Miltefosine in people with Visceral Leishmaniasis, run by Banaras Hindu University at 2 sites in India.
Trial summary
Miltefosine and liposomal amphotericin B (AmBisome) are approved drugs for visceral leishmaniasis. In this study both drugs will be given in a sequential manner. AmBisome will be given on day 1, followed by Miltefosine for 14 days. Final Cure will be evaluated at six months. Read more about this study
- Who is it for?
- Ages 2 to 65 years
- Conditions the study is for
- Visceral Leishmaniasis
- What is being tested?
- Liposomal amphotericin B and Miltefosine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesIndia
- Study dates
- Oct 2007to Feb 2010
- 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 2 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male and female age between 2 and 65 years (inclusive)
- Parasites visualized on splenic aspiration
- Signs and symptoms compatible with visceral leishmaniasis (e.g. fever, splenomegaly, anaemia, weight loss, leucopenia, thrombocytopenia)
- Confirmed diagnosis of VL by visualization of parasites on splenic/bone marrow aspirate
- Fever for at least 2 weeks
- Written informed consent from the patient/or from parent or guardian if under 18 years old
Who cannot join
- Hemoglobin < 6 g/dl
- White blood cell count < 1000/mm3
- Platelets <50,000
- Prothrombin time > 5 sec above control
- ASAT > 3 times the upper limit of normal
- Serum creatinine or BUN > 1.5 times the upper limit of normal
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- Malaria
- Tuberculosis
- HIV positive serology
- Lactation, pregnancy
- Refusing contraception method during treatment period plus 3 months
- Any medical condition(s) that upon judgment of physician may affect the safety of the patient when treated with study drugs
- Any concomitant drug that is nephrotoxic
Trial locations and contacts
2 sites in 1 country.
India2 sites
Kala-azar Medical Research Center
Muzaffarpur, Bihar, 842001
Rajendra Memorial Research Institute of Medical Sciences
Patna, Bihar
About this study
Official title: The Efficacy and Safety of a Short Course of Miltefosine and Liposomal Amphotericin B for Visceral Leishmaniasis in India
Miltefosine and liposomal amphotericin B (AmBisome) are approved drugs for visceral leishmaniasis. In this study both drugs will be given in a sequential manner. AmBisome will be given on day 1, followed by Miltefosine for 14 days. Final Cure will be evaluated at six months.
Read the detailed description
Methodology Multicenter trial, eligible patients will be treated with Liposomal amphotericin B (5 mg/kg) on day 1 and then with miltefosine capsules for 14 days (days 2-15).
At two weeks after the end of treatment the initial cure (clinical and parasitological cure) and the clinical response will be determined. If initial cure is observed, a patient will be evaluated after a 6 months (after end of treatment) follow up period for final clinical cure.
Number of patients planned Total number of patients planned: 150 patients at both centers combined. 75 pediatric (2-11 years); 75 adult (12-65 years).
Lack of suitability for the trial:
- Post Kala-azar Dermal Leishmaniasis (PKDL)
- Concomitant treatment with other anti-leishmanial drugs
- Any condition which compromises ability to comply with the study procedures
Administrative reasons:
- Any condition or situation that compromises compliance with study procedures including follow-up visit Study medication, dose and mode of administration Liposomal amphotericin B administered intravenously as single dose on day 1, Dosage: 5 mg/kg.
Miltefosine administered orally (50 mg capsules) for 14 days (on days 2-15)
Dosage:
- weighing ≥ 25 kg: 100 mg miltefosine daily as one capsule (50 mg) in the morning and one capsule in the evening, after meals for 14 days.
- weighing < 25 kg: 50 mg miltefosine daily as one capsule (50 mg) in the morning, after meals for 14 days. Parameter for evaluation
- Final cure rate (initial parasite cure and clinical assessment at six month EOT)
- Initial parasitological cure rate (based on splenic aspirates or Bone marrow aspirate)
- Clinical response at end of treatment (clinical assessment)
- Adverse events
Statistical methods
- Calculation of cure rate with 95% and 90% lower confidence limit according to Clopper Pearson
- Calculation of overall incidence of adverse events
- Conditions
- Visceral Leishmaniasis
- Being tested
- Liposomal amphotericin B and Miltefosine
- Keywords
- Visceral leishmaniasis, kala-azar, miltefosine, AmBisome
- Medical subject headings
- Leishmaniasis, Visceral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal amphotericin B and MiltefosineDrug
Also called AmBisome and Impavido
Liposomal amphotericin B administered intravenously as single dose on day 1, Dosage: 5 mg/kg.
Miltefosine administered orally (50 mg capsules) for 14 days (on days 2-15)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Liposomal amphotericin B administered intravenously as single dose on day 1, Dosage: 5 mg/kg.
Miltefosine administered orally (50 mg capsules) for 14 days (on days 2-15) Receives: Drug: Liposomal amphotericin B and Miltefosine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Final Cure six months after the end of treatment
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2006 (estimated)
- Study startOct 2007
- Primary completionAug 2009
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Banaras Hindu University
- Sponsor type
- University, hospital or other
- Collaborators
- Rajendra Memorial Research Institute of Medical Sciences
- Investigators
- Shyam Sundar, MD, Principal investigator, Banaras Hindu UniversityPrabhat K Sinha, MD, Principal investigator, Rajendra Memorial Research Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00371995
- Sponsor's protocol ID
- LEI PDE 06 03
- Status last verified
- Sep 2008
- First submitted
- 5 Sep 2006
- Last updated
- 22 Jun 2011
- Results posted
- No
Publications
Sundar S, Sinha PK, Verma DK, Kumar N, Alam S, Pandey K, Kumari P, Ravidas V, Chakravarty J, Verma N, Berman J, Ghalib H, Arana B. Ambisome plus miltefosine for Indian patients with kala-azar. Trans R Soc Trop Med Hyg. 2011 Feb;105(2):115-7. doi: 10.1016/j.trstmh.2010.10.008. Epub 2010 Dec 3.
PubMed 21129762
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of a Short Course of Miltefosine and Liposomal Amphotericin B for Visceral Leishmaniasis in India
- ClinicalTrials.gov ID
- NCT00371995
- Acronym / sponsor ID
- LEI PDE 06 03
- Conditions
- Visceral Leishmaniasis
- Keywords
- Visceral leishmaniasis, kala-azar, miltefosine, AmBisome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Banaras Hindu UniversityUniversity, hospital or other
- Collaborators
- Rajendra Memorial Research Institute of Medical Sciences
- Study start
- Oct 2007
- Primary completion
- Aug 2009 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 6 Sep 2006 (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.
Miltefosine and liposomal amphotericin B (AmBisome) are approved drugs for visceral leishmaniasis. In this study both drugs will be given in a sequential manner. AmBisome will be given on day 1, followed by Miltefosine for 14 days. Final Cure will be evaluated at six months.
Detailed description
Methodology Multicenter trial, eligible patients will be treated with Liposomal amphotericin B (5 mg/kg) on day 1 and then with miltefosine capsules for 14 days (days 2-15).
At two weeks after the end of treatment the initial cure (clinical and parasitological cure) and the clinical response will be determined. If initial cure is observed, a patient will be evaluated after a 6 months (after end of treatment) follow up period for final clinical cure.
Number of patients planned Total number of patients planned: 150 patients at both centers combined. 75 pediatric (2-11 years); 75 adult (12-65 years).
Lack of suitability for the trial:
- Post Kala-azar Dermal Leishmaniasis (PKDL)
- Concomitant treatment with other anti-leishmanial drugs
- Any condition which compromises ability to comply with the study procedures
Administrative reasons:
- Any condition or situation that compromises compliance with study procedures including follow-up visit Study medication, dose and mode of administration Liposomal amphotericin B administered intravenously as single dose on day 1, Dosage: 5 mg/kg.
Miltefosine administered orally (50 mg capsules) for 14 days (on days 2-15)
Dosage:
- weighing ≥ 25 kg: 100 mg miltefosine daily as one capsule (50 mg) in the morning and one capsule in the evening, after meals for 14 days.
- weighing < 25 kg: 50 mg miltefosine daily as one capsule (50 mg) in the morning, after meals for 14 days. Parameter for evaluation
- Final cure rate (initial parasite cure and clinical assessment at six month EOT)
- Initial parasitological cure rate (based on splenic aspirates or Bone marrow aspirate)
- Clinical response at end of treatment (clinical assessment)
- Adverse events
Statistical methods
- Calculation of cure rate with 95% and 90% lower confidence limit according to Clopper Pearson
- Calculation of overall incidence of adverse events
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Liposomal amphotericin B and MiltefosineLiposomal amphotericin B administered intravenously as single dose on day 1, Dosage: 5 mg/kg. Miltefosine administered orally (50 mg capsules) for 14 days (on days 2-15) |
Who may qualify
- Ages
- 2 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Male and female age between 2 and 65 years (inclusive)
- Parasites visualized on splenic aspiration
- Signs and symptoms compatible with visceral leishmaniasis (e.g. fever, splenomegaly, anaemia, weight loss, leucopenia, thrombocytopenia)
- Confirmed diagnosis of VL by visualization of parasites on splenic/bone marrow aspirate
- Fever for at least 2 weeks
Key exclusion criteria (13 listed)
- Hemoglobin < 6 g/dl
- White blood cell count < 1000/mm3
- Platelets <50,000
- Prothrombin time > 5 sec above control
- ASAT > 3 times the upper limit of normal
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 |
|---|---|---|
| Liposomal amphotericin B and MiltefosineAlso: AmBisome and ImpavidoLiposomal amphotericin B administered intravenously as single dose on day 1, Dosage: 5 mg/kg. Miltefosine administered orally (50 mg capsules) for 14 days (on days 2-15) | Drug | 1 |
Primary outcome
Final Cure six months after the end of treatment
Time frame: 1 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 22 Jun 2011.
- Results publication: PubMed 21129762Sundar S, Sinha PK, Verma DK, Kumar N, Alam S, Pandey K, Kumari P, Ravidas V, Chakravarty J, Verma N, Berman J, Ghalib H, Arana B. Ambisome plus miltefosine for Indian patients with kala-azar. Trans R Soc Trop Med Hyg. 2011 Feb;105(2):115-7. doi: 10.1016/j.trstmh.2010.10.008. Epub 2010 Dec 3.
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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, MD principal investigator
Banaras Hindu University
Prabhat K Sinha, MD principal investigator
Rajendra Memorial Research Institute of Medical Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Liposomal amphotericin B and Miltefosine in people with Visceral Leishmaniasis, run by Banaras Hindu University at 2 sites 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 6 inclusion and 13 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 22 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Final Cure six months after the end of treatment (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00371995, which also lists 1 linked publication.
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 22 Jun 2011.