26 completed, 5 terminated, 2 unknown, 1 not yet recruiting. 12 Phase 4, 9 Phase 3, 7 Phase 1, 7 Phase 2, 1 Not applicable.
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Single High-dose of Liposomal Amphotericin B in Combination With B/F/TAF for HIV/AIDS-associated Talaromycosis Amphotericin B, AmBisome - HIV/AIDS-associated Talaromycosis | Not applicable | Not yet recruiting | Shanghai Public Health Clinical Center | 116 | 2025-05-01 | 2025-04-13 |
| Bioequivalence of Amphotericin B Liposome for Injection Amphotericin B liposome for injection, AmBisome - Bioequivalence | Phase 1 | Completed | CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. | 32 | 2023-06-02 | 2023-09-28 |
| Pharmacokinetics and Safety of AmBisome and DKF-5122 AmBisome, DKF-5122 - Invasive Fungal Infections, Neutropenic Fever | Phase 1 | Completed | Dongkook Pharmaceutical Co., Ltd. | 38 | 2020-09-07 | 2023-03-01 |
| Nebulised Liposomal Amphotericin for Invasive Pulmonary Aspergillosis (NAIFI01 Study) Amphotericin B Liposomal 50 MG, Placebo - Invasive Pulmonary Aspergillosis | Phase 1 | Completed | Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal | 13 | 2019-10-18 | 2023-06-15 |
| Short Course Regimens for Treatment of PKDL (Sudan) Paromomycin, Ambisome, Miltefosine - PKDL - Post-Kala-Azar Dermal Leishmanioid | Phase 2 | Unknown | Drugs for Neglected Diseases | 110 | 2018-05-09 | 2020-01-18 |
| Steady State Global Bioequivalence Study of Amphotericin B Liposome for Injection 50 mg/ Vial in Fed Condition Amphotericin B Liposome, AmBisome (Amphotericin B) Liposome - Visceral Leishmaniasis | Phase 1 | Completed | Aurobindo Pharma Ltd | 140 | 2018-05-02 | 2019-08-26 |
| Liposomal Amphotericin B (AmBisome) Pharmacokinetics Given as a Single Intravenous Dose to Obese Patients (ASPEN) Administration of study drug - Morbid Obesity | Phase 4 | Completed | Radboud University Medical Center | 16 | 2018-03-22 | 2020-10-19 |
| Efficacy Trial of Ambisome Given Alone and Ambisome Given in Combination With Miltefosine for the Treatment of VL HIV Positive Ethiopian Patients. Liposomal Amphotericin B, Miltefosine - Visceral Leishmaniasis | Phase 3 | Completed | Drugs for Neglected Diseases | 59 | 2014-07-01 | 2019-04-08 |
| Single Dose Liposomal Amphotericin B for Visceral Leishmaniasis AMBISOME - Visceral Leishmaniasis | Phase 4 | Unknown | Banaras Hindu University | 1300 | 2014-06-01 | 2014-01-22 |
| Safety and Effectiveness of Short-course AmBisome in the Treatment of PKDL in Bangladesh AmBisome - Post-kala-azar Dermal Leishmaniasis | Phase 4 | Completed | Medecins Sans Frontieres, Netherlands | 280 | 2014-04-08 | 2017-10-17 |
| An Bioequivalence Study to Compare Two 2 mg/ml Liposomal Amphotericin B Injections in Healthy Subjects Liposomal Amphotericin B, AmBisome - Normal Healthy Subjects | Phase 1 | Completed | Taiwan Liposome Company | 36 | 2012-02-01 | 2013-11-27 |
| Anidulafungin vs Amphotericin B Safety in High Risk Hepatic Transplant Recipients Anidulafungin, Liposomal amphotericin B - Liver Disease, Fungal Infection | Phase 4 | Completed | Fundacion SEIMC-GESIDA | 61 | 2011-11-01 | 2014-05-30 |
| Liposomal Amphotericin in Disseminated Leishmaniasis Liposomal Amphotericin B - Disseminated Leishmaniasis | Phase 3 | Completed | Hospital Universitário Professor Edgard Santos | 20 | 2011-04-01 | 2014-01-01 |
| Prevention of Invasive Fungal Infections (IFIs) in Subjects Receiving Chemotherapy for Acute Lymphoblastic Leukemia Liposomal amphotericin B, Placebo - Invasive Fungal Disease | Phase 3 | Completed | Gilead Sciences | 355 | 2011-04-01 | 2015-05-07 |
| Efficacy and Safety Study of Drugs for Treatment of Visceral Leishmaniasis in Brazil Antimoniate of N-methylglucamine, amphotericin B deoxycholate, Liposomal amphotericin B - Visceral Leishmaniasis | Phase 4 | Terminated | University of Brasilia | 378 | 2011-02-01 | 2017-09-05 |
| Phase III, Study of Three Short Course Combo (Ambisome®, Miltefosine, Paromomycin) Compared With AmBisome for the Treatment of VL in Bangladesh Liposomal amphotericin B, liposomal amphotericin B + miltefosine, liposomal amphotericin B + paromomycin - Visceral Leishmaniasis | Phase 3 | Completed | Drugs for Neglected Diseases | 602 | 2010-05-01 | 2016-01-21 |
| High-Dose Fluconazole for the Treatment of Cryptococcal Meningitis in HIV-Infected Individuals Fluconazole, Amphotericin B - Cryptococcal Meningitis, HIV Infections | Phase 1 / Phase 2 | Completed | National Institute of Allergy and Infectious Diseases (NIAID) | 168 | 2010-04-16 | 2021-11-04 |
| Liver Transplant European Study Into the Prevention of Fungal Infection micafungin, fluconazole, liposomal amphotericin B - Liver Transplantation, Mycoses | Phase 3 | Completed | Astellas Pharma Inc | 350 | 2009-12-15 | 2024-11-18 |
| To Study the Effect Of Single Infusions Of Amphotericin B Lipid Preparations in Treatment of Patients Of Kala Azar Amphotericin B Lipid emulsion, Liposomal Amphotericin B - Leishmaniasis, Visceral | Phase 3 | Completed | Bharat Serums and Vaccines Limited | 500 | 2009-07-01 | 2011-06-02 |
| Open-Label, Sequential Step, Safety and Efficacy Study to Determine the Optimal Single Dose of Ambisome for Patients With VL Liposomal amphotericin B (Ambisome) - Visceral Leishmaniasis | Phase 2 | Terminated | Drugs for Neglected Diseases | 124 | 2009-04-01 | 2016-01-21 |
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Leishmaniasis, Visceral (9) · Invasive Fungal Infections (3) · Mycoses (3) · Candidemia (2) · Candidiasis (2) · Febrile Neutropenia (2) · Aspergillosis (1) · Candidiasis, Invasive (1) · HIV Infections (1) · Infections (1) · Invasive Pulmonary Aspergillosis (1) · Leishmaniasis (1) · Leukemia (1) · Leukemia, Myeloid, Acute (1) · Liver Diseases (1)
Gilead Sciences (7) · Drugs for Neglected Diseases (4) · Astellas Pharma Inc (3) · National Institute of Allergy and Infectious Diseases (NIAID) (3) · Banaras Hindu University (2) · Aurobindo Pharma Ltd (1) · Bharat Serums and Vaccines Limited (1) · Bill McGhee (1) · CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. (1) · Dongkook Pharmaceutical Co., Ltd. (1) · Duke University (1) · Fundacion SEIMC-GESIDA (1) · Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal (1) · Hospital Universitário Professor Edgard Santos (1) · M.D. Anderson Cancer Center (1)
United States (8) · India (6) · France (3) · Italy (3) · Spain (3) · Bangladesh (2) · Brazil (2) · Ethiopia (2) · Sudan (2) · United Kingdom (2) · Austria (1) · Belgium (1) · Canada (1) · China (1) · Germany (1)
Lamine Mahi, MD (2) · Shyam Sundar, MD (2) · Ana LT Rabello, MD PhD (1) · Andrea L de Carvalho, MD (1) · Asuncion Moreno, MD (1) · Bill McGhee, PharmD (1) · Carlos Cervera, MD (1) · Carlos HN Costa, MD PhD (1) · Danny Benjamin, MD (1) · David Sacks, PhD (1) · Dorcas L Costa, MD PhD (1) · Dr. Dinesh Mondal, MD (1)
PMID 19144094, PMID 19804626, PMID 20147716, PMID 21147825, PMID 21375777, PMID 24454970, PMID 25233346, PMID 25520332, PMID 26048961, PMID 26768369, PMID 28558062, PMID 28662034, PMID 30653490, PMID 30789910, PMID 36780493, PMID 37988402, PMID 39007942, PMID 41263912, PMID 41513548
2008 (1)