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| Name | Class |
|---|---|
| Gilead Sciences | INDUSTRY |
| Paladin Labs Inc. | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Milt | Experimental | Monotherapy course of Miltefosine at 2.5mg/kg body weight (oral) from days 1-28 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liposomal amphotericin B (AmBisome®) and sodium stibogluconate | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Initial cure: proportion cured at Day 28 | Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Final cure: proportion cured at day 210 | 6 months post treatment | |
| Adverse events and serious adverse events occurring in the three study arms | up to day 60 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Monique Wasunna, MD | Kenya Medical Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kimalel Health Centre | Kimalel | Kenya | ||||
| Kassab Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27627654 | Derived | 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. | |
| 26573827 |
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| ID | Type | URL | Comment |
|---|---|---|---|
| Study Protocol | View IPD |
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| Liposomal amphotericin B + miltefosine | Drug | 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 |
|
| Miltefosine | Drug | Monotherapy course of Miltefosine at 2.5mg/kg body weight (oral) from days 1-28 |
|
| Kassāb |
| Al Qaḑārif |
| Sudan |
| El Hassan Centre for Tropical Medicine | Doka | Gedarif | Sudan |
| Derived |
| Allison 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. |
| 21718522 | Derived | Omollo 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. |
Final Study Protocol |
| ID | Term |
|---|---|
| D007898 | Leishmaniasis, Visceral |
| ID | Term |
|---|---|
| D007896 | Leishmaniasis |
| D056986 | Euglenozoa Infections |
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D000079426 | Vector Borne Diseases |
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| ID | Term |
|---|---|
| C068538 | liposomal amphotericin B |
| D000967 | Antimony Sodium Gluconate |
| C039128 | miltefosine |
| ID | Term |
|---|---|
| D009930 | Organic Chemicals |
| D005942 | Gluconates |
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D006880 | Hydroxy Acids |
| D002241 | Carbohydrates |
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