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| Name | Class |
|---|---|
| Addis Ababa University | OTHER |
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This is a phase II/III open, comparative dose trial to find the lowest single dose of AmBisome for the treatment of primary, symptomatic visceral leishmaniasis(VL), in HIV negative patients. In this trial, the minimum effective dose will be determined in a sequential step, dose escalation design, which minimises the number of patients exposed to low, potentially inadequate doses and provides contemporaneous comparative data against the manufacturer's recommended dose schedule in this indication.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ambisome control: | Active Comparator | Ambisome, Total dose 21.0 mg given as 7 x 3mg on days 1,2,3,4,5, and 14 and 21 |
|
| Ambisome test | Experimental | Single dose Ambisome in sequence(7.5 / 10.0/ 12.5 / 15.0mg) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liposomal amphotericin B (Ambisome) | Drug | 21.0 mg/kg total dose. Given iv as 3mg/kg/day on days 1,2,3,4,5, and 14 and 21 |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary efficacy variable is parasitological clearance with no relapse at 6 months post treatment (ie definitive cure) assessed by clinical status and confirmed by splenic or bone marrow aspiration. | at 6 months post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Parasitological clearance at day 30. | Day 30 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sisay Yifru, MD | Gondar University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gondar | Gonder | Gondar | Ethiopia | |||
| Arba Minch LRTC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24454970 | Derived | Khalil EA, Weldegebreal T, Younis BM, Omollo R, Musa AM, Hailu W, Abuzaid AA, Dorlo TP, Hurissa Z, Yifru S, Haleke W, Smith PG, Ellis S, Balasegaram M, EL-Hassan AM, Schoone GJ, Wasunna M, Kimutai R, Edwards T, Hailu A. Safety and efficacy of single dose versus multiple doses of AmBisome for treatment of visceral leishmaniasis in eastern Africa: a randomised trial. PLoS Negl Trop Dis. 2014 Jan 16;8(1):e2613. doi: 10.1371/journal.pntd.0002613. eCollection 2014. | |
| 21375777 |
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| Liposomal amphotericin B (Ambisome) | Drug | liposomal amphotericin b given intravenously as single dose at 7.5 mg/kg increasing to 10, 12.5 and 15.0mg/kg depending on results of interim analyses. |
|
|
| Arba Minch |
| Ethiopia |
| Kassab Hospital | Kassāb | Gedarif | Sudan |
| Derived |
| Edwards T, Omollo R, Khalil EA, Yifru S, Musa B, Musa A, Wasunna M, Smith PG, Royce C, Ellis S, Balasegaram M, Hailu A. Single-dose liposomal amphotericin B (AmBisome(R)) for the treatment of visceral leishmaniasis in East Africa: study protocol for a randomized controlled trial. Trials. 2011 Mar 6;12:66. doi: 10.1186/1745-6215-12-66. |
| 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 |
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