Leishmaniasis, VisceralPhase 3NCT00523965
Combination Therapy in Indian Visceral Leishmaniasis
A Phase 3 study testing amphotericin B deoxycholate, Liposomal Amphotericin B with Miltefosine and Liposomal Amphotericin B and Paromomycin Sulfate in people with Leishmaniasis, Visceral, run by Banaras Hindu University at 1 site in India.
Trial summary
Rationale The overall objective of this trial is to identify a safe and effective combination, (co-administration) short course treatment for the treatment of VL which could be easily deployed in a control programme. Read more about this study
- Who is it for?
- Ages 12 to 60 years
- Conditions the study is for
- Leishmaniasis, Visceral
- What is being tested?
- amphotericin B deoxycholate, Liposomal Amphotericin B with Miltefosine and Liposomal Amphotericin B and Paromomycin Sulfate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 624 participants
- Where
- 1 siteIndia
- Study dates
- Sep 2007to Feb 2010
- Phase
- Phase 3
- 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 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients > 5 years old with symptoms and signs of kala-azar (fever, weight loss, splenomegaly) and parasites demonstrated by microscopy in splenic aspirate smear
Who cannot join
- Pregnant or breast-feeding women
- Individuals seropositive to HIV or individuals with a serious concurrent infection such as tuberculosis or bacterial pneumonia.
- Women of child-bearing age will be counseled about adequate birth control during and for three months after miltefosine treatment and provided with a satisfactory method of contra-ception.
- Granulocyte count < 1,000/mm3, hemoglobin < 5 g/dL or platelet count < 40,000/mm3
- Hepatic transaminases or total bilirubin greater than three times normal
- Serum creatinine > 2.0 mg/dL
- Prothrombin time > 5 seconds above control
- Inability of subject or guardian to provide written informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Open-label, Parallel-group, Safety and Efficacy Study to Evaluate Different Combination Treatment Regimens (Co-administration), of AmBisome, Paromomycin and Miltefosine in Visceral Leishmaniasis (VL)
Rationale
The overall objective of this trial is to identify a safe and effective combination, (co-administration) short course treatment for the treatment of VL which could be easily deployed in a control programme. The hypothesis is that the combination treatment is as effective or better than the 5 mg/kg single dose of AmBisome and will reduce the risk of parasite resistance occurring. Safety and tolerability should be such that the combination can be easily deployed.
Read more
Objective
The specific primary and secondary objectives are as follows:
Primary objective:
To identify a short course combination treatment regimen which is at least as effective as a single dose of AmBisome 5mg/kg
Secondary objective:
To compare safety and tolerability of the various treatments measured by vital signs, blood biochemistry, (renal and liver function tests) haematology, spontaneous and elicited adverse event reporting
Primary Endpoint:
The primary efficacy endpoint variable is parasitological clearance 2 weeks after start of treatment with no relapse during follow up and no clinical signs or symptoms of VL at 6 months post treatment.
Parasitology is only carried out at any time during follow-up or at six months post treatment if there are signs or symptoms of VL infection.
- Conditions
- Leishmaniasis, Visceral
- Being tested
- amphotericin B deoxycholate, Liposomal Amphotericin B with Miltefosine, Liposomal Amphotericin B and Paromomycin Sulfate, miltefosine + Paromomycin sulfate
- Keywords
- Kala-azar, miltefosine, liposomal amphotericin B
- 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 deoxycholateDrug
Amphotericin B deoxycholate 1 mg/kg on alternate days for 15 infusions
Liposomal Amphotericin B with MiltefosineDrug
Liposomal Amphotericin B 5 mg Miltefosine 50 mg twice daily if patient weighs equal to or > 25 kg Miltefosine 50 mg once daily if patient weighs <25 mg
Liposomal Amphotericin B and Paromomycin SulfateDrug
AmBisome 5mg/kg iv infusion over 2 h x 1 day (single dose) + paromomycin sulfate 15 mg/kg/day i.m for 10 days, on day 2-11
miltefosine + Paromomycin sulfateDrug
oral miltefosine 50mg once daily (< 25 kg body weight) or twice daily ( > 25 kg body weight) or 2.5 mg/kg for children under 12 years, for 10 days + Paromomycin sulfate 15 mg/kg/day im. for 10 days
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | AmBisome 5 mg/kg iv infusion over 2 h x 1 day (single dose) + oral miltefosine 50mg once daily (< 25 kg body weight) or twice daily ( > 25 kg body weight) or 2.5 mg/kg for children under 12 years, for 7 days on day 2-8 Receives: Drug: Liposomal Amphotericin B with Miltefosine |
| B | Experimental | AmBisome 5mg/kg iv infusion over 2 h x 1 day (single dose) + paromomycin sulfate 15 mg/kg/day i.m for 10 days, on day 2-11 Receives: Drug: Liposomal Amphotericin B and Paromomycin Sulfate |
| C | Experimental | oral miltefosine 50mg once daily (< 25 kg body weight) or twice daily ( > 25 kg body weight) or 2.5 mg/kg for children under 12 years, for 10 days + Paromomycin sulfate 15 mg/kg/day im. for 10 days Receives: Drug: miltefosine + Paromomycin sulfate |
| D | Active comparator | amphotericin B deoxycholate at 1 mg/kg every other day for 15 infusions Receives: Drug: amphotericin B deoxycholate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Final cure at six month follow up
Measured: 18 months
Cure at six month follow up
Measured: 12 months
Secondary outcomes (1)
Initial cure at the end of treatment
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2007 (estimated)
- Study startSep 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.
- Other trials for Leishmaniasis, VisceralStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 624 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Banaras Hindu University
- Sponsor type
- University, hospital or other
- Collaborators
- Drugs for Neglected Diseases, Rajendra Memorial Research Institute of Medical Sciences
- Investigators
- Shyam Sundar, MD, Principal investigator, Institute of Medical Sciences, Banaras HIndu UniversityP K Sinha, MD, Principal investigator, Rajendra Memorial Research Insititute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00523965
- Sponsor's protocol ID
- VLCombo 07
- Status last verified
- Jan 2009
- First submitted
- 31 Aug 2007
- Last updated
- 26 May 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Open-label, Parallel-group, Safety and Efficacy Study to Evaluate Different Combination Treatment Regimens (Co-administration), of AmBisome, Paromomycin and Miltefosine in Visceral Leishmaniasis (VL)
- ClinicalTrials.gov ID
- NCT00523965
- Acronym / sponsor ID
- VLCombo 07
- Conditions
- Leishmaniasis, Visceral
- Keywords
- Kala-azar, miltefosine, liposomal amphotericin B
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 624 participants (estimated)
- Lead sponsor
- Banaras Hindu UniversityUniversity, hospital or other
- Collaborators
- Drugs for Neglected Diseases, Rajendra Memorial Research Institute of Medical Sciences
- Study start
- Sep 2007
- Primary completion
- Aug 2009 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 3 Sep 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.
Rationale
The overall objective of this trial is to identify a safe and effective combination, (co-administration) short course treatment for the treatment of VL which could be easily deployed in a control programme. The hypothesis is that the combination treatment is as effective or better than the 5 mg/kg single dose of AmBisome and will reduce the risk of parasite resistance occurring. Safety and tolerability should be such that the combination can be easily deployed.
Objective
The specific primary and secondary objectives are as follows:
Primary objective:
To identify a short course combination treatment regimen which is at least as effective as a single dose of AmBisome 5mg/kg
Secondary objective:
To compare safety and tolerability of the various treatments measured by vital signs, blood biochemistry, (renal and liver function tests) haematology, spontaneous and elicited adverse event reporting
Primary Endpoint:
The primary efficacy endpoint variable is parasitological clearance 2 weeks after start of treatment with no relapse during follow up and no clinical signs or symptoms of VL at 6 months post treatment.
Parasitology is only carried out at any time during follow-up or at six months post treatment if there are signs or symptoms of VL infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Liposomal Amphotericin B with MiltefosineAmBisome 5 mg/kg iv infusion over 2 h x 1 day (single dose) + oral miltefosine 50mg once daily (< 25 kg body weight) or twice daily ( > 25 kg body weight) or 2.5 mg/kg for children under 12 years, for 7 days on day 2-8 |
| B | Experimental | Drug: Liposomal Amphotericin B and Paromomycin SulfateAmBisome 5mg/kg iv infusion over 2 h x 1 day (single dose) + paromomycin sulfate 15 mg/kg/day i.m for 10 days, on day 2-11 |
| C | Experimental | Drug: miltefosine + Paromomycin sulfateoral miltefosine 50mg once daily (< 25 kg body weight) or twice daily ( > 25 kg body weight) or 2.5 mg/kg for children under 12 years, for 10 days + Paromomycin sulfate 15 mg/kg/day im. for 10 days |
| D | Active comparator | Drug: amphotericin B deoxycholateamphotericin B deoxycholate at 1 mg/kg every other day for 15 infusions |
Who may qualify
- Ages
- 12 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patients > 5 years old with symptoms and signs of kala-azar (fever, weight loss, splenomegaly) and parasites demonstrated by microscopy in splenic aspirate smear
Key exclusion criteria (8 listed)
- Pregnant or breast-feeding women
- Individuals seropositive to HIV or individuals with a serious concurrent infection such as tuberculosis or bacterial pneumonia.
- Women of child-bearing age will be counseled about adequate birth control during and for three months after miltefosine treatment and provided with a satisfactory method of contra-ception.
- Granulocyte count < 1,000/mm3, hemoglobin < 5 g/dL or platelet count < 40,000/mm3
- Hepatic transaminases or total bilirubin greater than three times 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 |
|---|---|---|
| amphotericin B deoxycholateAmphotericin B deoxycholate 1 mg/kg on alternate days for 15 infusions | Drug | D |
| Liposomal Amphotericin B with MiltefosineLiposomal Amphotericin B 5 mg Miltefosine 50 mg twice daily if patient weighs equal to or > 25 kg Miltefosine 50 mg once daily if patient weighs <25 mg | Drug | A |
| Liposomal Amphotericin B and Paromomycin SulfateAmBisome 5mg/kg iv infusion over 2 h x 1 day (single dose) + paromomycin sulfate 15 mg/kg/day i.m for 10 days, on day 2-11 | Drug | B |
| miltefosine + Paromomycin sulfateoral miltefosine 50mg once daily (< 25 kg body weight) or twice daily ( > 25 kg body weight) or 2.5 mg/kg for children under 12 years, for 10 days + Paromomycin sulfate 15 mg/kg/day im. for 10 days | Drug | C |
Primary outcome
Final cure at six month follow up
Time frame: 18 months
Cure at six month follow up
Time frame: 12 months
1 secondary outcome
Initial cure at the end of treatment
Time frame: 12 months
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 26 May 2010.
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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
Institute of Medical Sciences, Banaras HIndu University
P K Sinha, MD principal investigator
Rajendra Memorial Research Insititute of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing amphotericin B deoxycholate, Liposomal Amphotericin B with Miltefosine and Liposomal Amphotericin B and Paromomycin Sulfate in people with Leishmaniasis, Visceral, 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 1 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 26 May 2010. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 at six month follow up (time frame: 18 months). The study lists 2 primary outcomes in all. 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 26 May 2010.