Visceral LeishmaniasisPhase 2NCT00370825
Combination Chemotherapy for the Treatment of Indian Kala-Azar
A Phase 2 study testing Combination therapy with AmBisome and miltefosine in people with Visceral Leishmaniasis, run by Banaras Hindu University at 1 site in India.
Trial summary
The investigators are using a sequential design to combine miltefosine and AmBisome in different doses. Read more about this study
- Who is it for?
- Ages 12 to 65 years
- Conditions the study is for
- Visceral Leishmaniasis
- What is being tested?
- Combination therapy with AmBisome and miltefosine
- How many people
- 200 participants
- Where
- 1 siteIndia
- Study dates
- Sep 2006to not given
- 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 12 to 65 years
- All sexes
- Child, Adult, Older adult
Who may be able to join
- Clinical diagnosis of active VL with consistent signs and symptoms (e.g., fever, splenomegaly).
- Confirmed diagnosis by bone-marrow or splenic aspirate smear showing characteristic amastigotes.
- Male or female.
- Ages 12 to 65 years.
- Both newly diagnosed cases and patients who have received previous treatment (in the latter case a 2-week wash-out will be required before starting the study treatment).
- WBC > 1,000/mm3.
- Hemoglobin ≥ 4 g/dL
Who cannot join
- Pregnancy or breast-feeding.
- HIV positive serology.
- ASAT, ALAT, AP ≥ 3 times upper limit of normal range.
- Bilirubin ≥ 2 times upper limit of normal range.
- Prothrombin time ≥ 5 seconds above control.
- Serum creatinine or BUN ≥ 1.5 times upper limit of normal range.
- Any medical condition or situation that compromises compliance with study procedures.
- HIV
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combination Chemotherapy for the Treatment of Indian Visceral Leishmaniasis: Miltefosine Plus Liposomal Amphotericin B - Dose and Duration Ranging Study
The investigators are using a sequential design to combine miltefosine and AmBisome in different doses.
Read the detailed description
In this sequential design four arm study one arm is a reference arm but the three arms will consist an of initial dose of liposomal amphotericin B on first day followed by miltefosine. Both the drugs will be used in different doses. Reference arm will consist only a single dose of amBisome at 5 mg/kg. After the end of treatment, the post treatment assessment will be done on day 16 (initial cure) and six months (final cure). Safety parameters will be evaluated on day 0, 8 and 16. An arm with an efficacy of less than 75% will be closed. There will be periodical assessment of study results after completion of 5 patients in each arm.
- Conditions
- Visceral Leishmaniasis
- Being tested
- Combination therapy with AmBisome and miltefosine
- Keywords
- Visceral leishmaniasis, miltefosine, AmBisome, Combination
- Medical subject headings
- Leishmaniasis, Visceral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combination therapy with AmBisome and miltefosineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Absence of clinical kala-azar at six month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2006 (estimated)
- Study startSep 2006
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- Banaras Hindu University
- Sponsor type
- University, hospital or other
- Investigators
- Shyam Sundar, MD, Principal investigator, Banaras Hindu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00370825
- Sponsor's protocol ID
- KAMRC0601
- Status last verified
- Sep 2008
- First submitted
- 31 Aug 2006
- Last updated
- 12 Sep 2008
- Results posted
- No
Publications
Sundar S, Rai M, Chakravarty J, Agarwal D, Agrawal N, Vaillant M, Olliaro P, Murray HW. New treatment approach in Indian visceral leishmaniasis: single-dose liposomal amphotericin B followed by short-course oral miltefosine. Clin Infect Dis. 2008 Oct 15;47(8):1000-6. doi: 10.1086/591972.
PubMed 18781879
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
- Combination Chemotherapy for the Treatment of Indian Visceral Leishmaniasis: Miltefosine Plus Liposomal Amphotericin B - Dose and Duration Ranging Study
- ClinicalTrials.gov ID
- NCT00370825
- Acronym / sponsor ID
- KAMRC0601
- Conditions
- Visceral Leishmaniasis
- Keywords
- Visceral leishmaniasis, miltefosine, AmBisome, Combination
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants
- Lead sponsor
- Banaras Hindu UniversityUniversity, hospital or other
- Study start
- Sep 2006
- First posted
- 1 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.
The investigators are using a sequential design to combine miltefosine and AmBisome in different doses.
Detailed description
In this sequential design four arm study one arm is a reference arm but the three arms will consist an of initial dose of liposomal amphotericin B on first day followed by miltefosine. Both the drugs will be used in different doses. Reference arm will consist only a single dose of amBisome at 5 mg/kg. After the end of treatment, the post treatment assessment will be done on day 16 (initial cure) and six months (final cure). Safety parameters will be evaluated on day 0, 8 and 16. An arm with an efficacy of less than 75% will be closed. There will be periodical assessment of study results after completion of 5 patients in each arm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Clinical diagnosis of active VL with consistent signs and symptoms (e.g., fever, splenomegaly).
- Confirmed diagnosis by bone-marrow or splenic aspirate smear showing characteristic amastigotes.
- Male or female.
- Ages 12 to 65 years.
- Both newly diagnosed cases and patients who have received previous treatment (in the latter case a 2-week wash-out will be required before starting the study treatment).
Key exclusion criteria (8 listed)
- Pregnancy or breast-feeding.
- HIV positive serology.
- ASAT, ALAT, AP ≥ 3 times upper limit of normal range.
- Bilirubin ≥ 2 times upper limit of normal range.
- Prothrombin time ≥ 5 seconds above control.
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 |
|---|---|---|
| Combination therapy with AmBisome and miltefosine | Drug | – |
Primary outcome
Absence of clinical kala-azar at six month follow up
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.
- Derived from this study: PubMed 18781879Sundar S, Rai M, Chakravarty J, Agarwal D, Agrawal N, Vaillant M, Olliaro P, Murray HW. New treatment approach in Indian visceral leishmaniasis: single-dose liposomal amphotericin B followed by short-course oral miltefosine. Clin Infect Dis. 2008 Oct 15;47(8):1000-6. doi: 10.1086/591972.
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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
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 Combination therapy with AmBisome and miltefosine 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 7 inclusion and 8 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?
Absence of clinical kala-azar at six month follow up. 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 NCT00370825, 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 12 Sep 2008.