Primary Visceral LeishmaniasisPhase 2NCT01067443
Clinical Trial to Assess the Safety and Efficacy of Sodium Stibogluconate (SSG) and AmBisome® Combination, Miltefosine and AmBisome® and Miltefosine Alone for the Treatment Visceral Leishmaniasis in Eastern Africa
A Phase 2 study testing Liposomal amphotericin B (AmBisome®) and sodium stibogluconate, Liposomal amphotericin B + miltefosine and Miltefosine in people with Primary Visceral Leishmaniasis, run by Drugs for Neglected Diseases at 3 sites in 2 countries.
Trial summary
This study is to assess if shorter combinations of SSG plus single dose AmBisome®, Miltefosine plus single dose AmBisome® and Miltefosine alone are effective in treating visceral leishmaniasis in Eastern Africa. Read more about this study
- Who is it for?
- Ages 7 to 60 years
- Conditions the study is for
- Primary Visceral Leishmaniasis
- What is being tested?
- Liposomal amphotericin B (AmBisome®) and sodium stibogluconate, Liposomal amphotericin B + miltefosine 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
- 151 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Mar 2010to Jun 2011
- 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 7 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients with clinical signs and symptoms of VL and diagnosis confirmed by visualization of parasites in tissue samples (lymph node, bone marrow or spleen where relevant) on microscopy.
- Patients aged between 7 (to allow for blood sampling) and 60 years (inclusive) who are able to comply with the protocol.
- Patients for whom written informed consent has been signed by the patients themselves (if aged 18 years and over) or by parents(s) or legal guardian for patients under 18 years of age.
- HIV negative status
Who cannot join
- Patients who have received any anti-leishmanial drugs in the last 6 months/ relapse cases.
- Patients with a negative lymph node/bone marrow (or spleen) smears.
- Patients with severe protein and or caloric malnutrition (Kwashiorkor or marasmus ; Adults: BMI </= 15, Children W/H<70, presence of oedema)
- Patients with previous history of hypersensitivity reaction to SSG or Amphotericin B.
- Patients suffering from a concomitant severe infection such as TB or any other serious underlying disease (cardiac, renal, hepatic) which would preclude evaluation of the patient's response to study medication.
- Patients suffering from other conditions associated with splenomegaly such as schistosomiasis.
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- Patients with previous history of cardiac arrhythmia or an abnormal ECG
- Patients who are female of child bearing age (all females who have achieved menarche) / pregnant or lactating.
- Patients with haemoglobin < 5gm/dl.
- Patients with WBC < 1 x 10³/mm³.
- Patients with platelets < 40,000/mm³.
- Patients with abnormal liver function (ALT and AST) tests of more than three times the normal range.
- Patients with serum creatinine outside the normal range for age and gender.
- Major surgical intervention within 2 weeks prior to enrolment.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Sudan2 sites
El Hassan Centre for Tropical Medicine
Doka, Gedarif
Kassab Hospital
Kassāb, Al Qaḑārif
About this study
Official title: A Phase II Randomized, Parallel Arm, Open-labeled Clinical Trial to Assess the Safety and Efficacy of the Combination of Sodium Stibogluconate Plus Single Dose AmBisome®, Miltefosine Plus Single Dose AmBisome® and Miltefosine Alone for the Treatment of Primary Visceral Leishmaniasis in Eastern Africa
This study is to assess if shorter combinations of SSG plus single dose AmBisome®, Miltefosine plus single dose AmBisome® and Miltefosine alone are effective in treating visceral leishmaniasis in Eastern Africa.
Read the detailed description
The current study intends to look at potential feasible short course combination therapies as well as evaluate (and possibly register) miltefosine in its conventional dose against VL in Sudan and Kenya.
- Conditions
- Primary Visceral Leishmaniasis
- Being tested
- Liposomal amphotericin B (AmBisome®) and sodium stibogluconate, Liposomal amphotericin B + miltefosine, Miltefosine
- Keywords
- Phase II, Randomised clinical trial, Visceral Leishmaniasis
- 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 (AmBisome®) and sodium stibogluconateDrug
AmBisome® one dose of 10mg/kg body weight (IV) on day 1 followed by 10 days of SSG at 20mg/kg body weight (IV/IM) from days 2-11
Liposomal amphotericin B + miltefosineDrug
AmBisome® one dose of 10mg/kg body weight (IV) on day 1 followed by 10 days Miltefosine at 2.5mg/kg body weight (oral) from days 2-11
MiltefosineDrug
Monotherapy course of Miltefosine at 2.5mg/kg body weight (oral) from days 1-28
| Study group | Role | What they receive |
|---|---|---|
| Amb+SSG | Experimental | AmBisome® one dose of 10mg/kg body weight (IV) on day 1 followed by 10 days of SSG at 20mg/kg body weight (IV/IM) from days 2-11 Receives: Drug: Liposomal amphotericin B (AmBisome®) and sodium stibogluconate |
| Amb+Milt | Experimental | AmBisome® one dose of 10mg/kg body weight (IV) on day 1 followed by 10 days Miltefosine at 2.5mg/kg body weight (oral) from days 2-11 Receives: Drug: Liposomal amphotericin B + miltefosine |
| Milt | Experimental | Monotherapy course of Miltefosine at 2.5mg/kg body weight (oral) from days 1-28 Receives: Drug: Miltefosine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Initial cure: proportion cured at Day 28
Measured: Day 28
Secondary outcomes (2)
Final cure: proportion cured at day 210
Measured: 6 months post treatment
Adverse events and serious adverse events occurring in the three study arms
Measured: up to day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2010 (estimated)
- Study startMar 2010
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Primary 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
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Drugs for Neglected Diseases
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences, Paladin Labs Inc.
- Responsible party
- Sponsor
- Investigators
- Monique Wasunna, MD, Principal investigator, Kenya Medical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01067443
- Sponsor's protocol ID
- LEAP 0208
- Status last verified
- Apr 2017
- First submitted
- 10 Feb 2010
- Last updated
- 24 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wasunna M, Njenga S, Balasegaram M, Alexander N, Omollo R, Edwards T, Dorlo TP, Musa B, Ali MH, Elamin MY, Kirigi G, Juma R, Kip AE, Schoone GJ, Hailu A, Olobo J, Ellis S, Kimutai R, Wells S, Khalil EA, Strub Wourgaft N, Alves F, Musa A. Efficacy and Safety of AmBisome in Combination with Sodium Stibogluconate or Miltefosine and Miltefosine Monotherapy for African Visceral Leishmaniasis: Phase II Randomized Trial. PLoS Negl Trop Dis. 2016 Sep 14;10(9):e0004880. doi: 10.1371/journal.pntd.0004880. eCollection 2016 Sep.
PubMed 27627654Allison A, Edwards T, Omollo R, Alves F, Magirr D, E Alexander ND. Generalizing boundaries for triangular designs, and efficacy estimation at extended follow-ups. Trials. 2015 Nov 16;16:522. doi: 10.1186/s13063-015-1018-1.
PubMed 26573827Omollo R, Alexander N, Edwards T, Khalil EA, Younis BM, Abuzaid AA, Wasunna M, Njoroge N, Kinoti D, Kirigi G, Dorlo TP, Ellis S, Balasegaram M, Musa AM. Safety and efficacy of miltefosine alone and in combination with sodium stibogluconate and liposomal amphotericin B for the treatment of primary visceral leishmaniasis in East Africa: study protocol for a randomized controlled trial. Trials. 2011 Jun 30;12:166. doi: 10.1186/1745-6215-12-166.
PubMed 21718522
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized, Parallel Arm, Open-labeled Clinical Trial to Assess the Safety and Efficacy of the Combination of Sodium Stibogluconate Plus Single Dose AmBisome®, Miltefosine Plus Single Dose AmBisome® and Miltefosine Alone for the Treatment of Primary Visceral Leishmaniasis in Eastern Africa
- ClinicalTrials.gov ID
- NCT01067443
- Acronym / sponsor ID
- LEAP 0208
- Conditions
- Primary Visceral Leishmaniasis
- Keywords
- Phase II, Randomised clinical trial, Visceral Leishmaniasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Drugs for Neglected DiseasesUniversity, hospital or other
- Collaborators
- Gilead Sciences, Paladin Labs Inc.
- Study start
- Mar 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 11 Feb 2010 (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.
This study is to assess if shorter combinations of SSG plus single dose AmBisome®, Miltefosine plus single dose AmBisome® and Miltefosine alone are effective in treating visceral leishmaniasis in Eastern Africa.
Detailed description
The current study intends to look at potential feasible short course combination therapies as well as evaluate (and possibly register) miltefosine in its conventional dose against VL in Sudan and Kenya.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Amb+SSG | Experimental | Drug: Liposomal amphotericin B (AmBisome®) and sodium stibogluconateAmBisome® one dose of 10mg/kg body weight (IV) on day 1 followed by 10 days of SSG at 20mg/kg body weight (IV/IM) from days 2-11 |
| Amb+Milt | Experimental | Drug: Liposomal amphotericin B + miltefosineAmBisome® one dose of 10mg/kg body weight (IV) on day 1 followed by 10 days Miltefosine at 2.5mg/kg body weight (oral) from days 2-11 |
| Milt | Experimental | Drug: MiltefosineMonotherapy course of Miltefosine at 2.5mg/kg body weight (oral) from days 1-28 |
Who may qualify
- Ages
- 7 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Patients with clinical signs and symptoms of VL and diagnosis confirmed by visualization of parasites in tissue samples (lymph node, bone marrow or spleen where relevant) on microscopy.
- Patients aged between 7 (to allow for blood sampling) and 60 years (inclusive) who are able to comply with the protocol.
- Patients for whom written informed consent has been signed by the patients themselves (if aged 18 years and over) or by parents(s) or legal guardian for patients under 18 years of age.
- HIV negative status
Key exclusion criteria (14 listed)
- Patients who have received any anti-leishmanial drugs in the last 6 months/ relapse cases.
- Patients with a negative lymph node/bone marrow (or spleen) smears.
- Patients with severe protein and or caloric malnutrition (Kwashiorkor or marasmus ; Adults: BMI </= 15, Children W/H<70, presence of oedema)
- Patients with previous history of hypersensitivity reaction to SSG or Amphotericin B.
- Patients suffering from a concomitant severe infection such as TB or any other serious underlying disease (cardiac, renal, hepatic) which would preclude evaluation of the patient's response to study medication.
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 (AmBisome®) and sodium stibogluconateAmBisome® one dose of 10mg/kg body weight (IV) on day 1 followed by 10 days of SSG at 20mg/kg body weight (IV/IM) from days 2-11 | Drug | Amb+SSG |
| Liposomal amphotericin B + miltefosineAmBisome® one dose of 10mg/kg body weight (IV) on day 1 followed by 10 days Miltefosine at 2.5mg/kg body weight (oral) from days 2-11 | Drug | Amb+Milt |
| MiltefosineMonotherapy course of Miltefosine at 2.5mg/kg body weight (oral) from days 1-28 | Drug | Milt |
Primary outcome
Initial cure: proportion cured at Day 28
Time frame: Day 28
2 secondary outcomes
Final cure: proportion cured at day 210
Time frame: 6 months post treatment
Adverse events and serious adverse events occurring in the three study arms
Time frame: up to day 60
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 24 Apr 2017.
- Derived from this study: PubMed 27627654Wasunna M, Njenga S, Balasegaram M, Alexander N, Omollo R, Edwards T, Dorlo TP, Musa B, Ali MH, Elamin MY, Kirigi G, Juma R, Kip AE, Schoone GJ, Hailu A, Olobo J, Ellis S, Kimutai R, Wells S, Khalil EA, Strub Wourgaft N, Alves F, Musa A. Efficacy and Safety of AmBisome in Combination with Sodium Stibogluconate or Miltefosine and Miltefosine Monotherapy for African Visceral Leishmaniasis: Phase II Randomized Trial. PLoS Negl Trop Dis. 2016 Sep 14;10(9):e0004880. doi: 10.1371/journal.pntd.0004880. eCollection 2016 Sep.
- Derived from this study: PubMed 26573827Allison A, Edwards T, Omollo R, Alves F, Magirr D, E Alexander ND. Generalizing boundaries for triangular designs, and efficacy estimation at extended follow-ups. Trials. 2015 Nov 16;16:522. doi: 10.1186/s13063-015-1018-1.
- Derived from this study: PubMed 21718522Omollo R, Alexander N, Edwards T, Khalil EA, Younis BM, Abuzaid AA, Wasunna M, Njoroge N, Kinoti D, Kirigi G, Dorlo TP, Ellis S, Balasegaram M, Musa AM. Safety and efficacy of miltefosine alone and in combination with sodium stibogluconate and liposomal amphotericin B for the treatment of primary visceral leishmaniasis in East Africa: study protocol for a randomized controlled trial. Trials. 2011 Jun 30;12:166. doi: 10.1186/1745-6215-12-166.
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.
Monique Wasunna, MD principal investigator
Kenya Medical Research Institute
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Liposomal amphotericin B (AmBisome®) and sodium stibogluconate, Liposomal amphotericin B + miltefosine and Miltefosine in people with Primary Visceral Leishmaniasis, run by Drugs for Neglected Diseases at 3 sites in 2 countries.
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 14 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 24 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sudan, Kenya. 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?
Initial cure: proportion cured at Day 28 (time frame: Day 28). 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 NCT01067443, which also lists 3 linked publications.
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 24 Apr 2017.