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Also known as Liposomal amphotericin B, Liposomal Amphotericin B (LAmB)
Liposomal amphotericin B and stibogluconate · 3 trials · 3 indications
Poor outcomes are defined as of death, talaromycosis complications (defined as relapse, immune inflammatory reconstitution inflammatory syndrome \[IRIS\], wasting syndrome \[\>10% weight loss from enrollment\], re-hospitalization, and grade 3 or higher adverse events
Diagnoses of proven or probable invasive fungal infections (IFI) were assessed according to European Organization for Research and Treatment of Cancer/Mycoses Study Group (EORTC/MSG) criteria by the independent data review board (IDRB) who were blinded to treatment assignment. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
| Arm | Type | Description |
|---|---|---|
| Deoxycholate Amphotericin B (DAmB) plus Flucytosine (5FC) placebo | ACTIVE_COMPARATOR | DAmB (0.7mg/kg/d IV x 14 days) + 5FC placebo (25 mg/kg oral 3x daily x 14 days) |
| Deoxycholate Amphotericin B (DAmB) plus Flucytosine (5FC) | EXPERIMENTAL | DAmB (0.7 mg/kg/d IV x 14 days) + 5FC (25 mg/kg oral 3x daily x 14 days) |
| Liposomal Amphotericin B (LAmB) plus Flucytosine (5FC) placebo | EXPERIMENTAL | LAmB (10 mg/kg IV x 1 dose) + 5FC placebo (25 mg/kg oral 3x daily x 14 days) |
| Liposomal Amphotericin B (LAmB) plus Flucytosine (5FC) | EXPERIMENTAL | LAmB (10 mg/kg IV x 1 dose) + 5FC (25 mg/kg oral 3x daily x 14 days) |
| Liposomal amphotericin B | EXPERIMENTAL | Liposomal amphotericin B 5 mg/kg twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy |
| Placebo | PLACEBO_COMPARATOR | Placebo to match liposomal amphotericin B twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy |
| 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 |
|---|---|---|
| Liposomal Amphotericin B (LAmB) | DRUG | Antifungal dosed at 10 mg/kg/day IV x one single dose. |
| Flucytosine (5FC) | DRUG | Antifungal dosed at 25mg/kg oral 3x daily. |
| Flucytosine (5FC) placebo pill | DRUG | Similar in appearance to flucytosine. Also dosed at 25mg/kg oral 3x daily. |
| Deoxycholate Amphotericin B (DAmB) | DRUG | Antifungal dosed at 0.7 mg/kg/day IV x 2 weeks. |
| Liposomal amphotericin B | DRUG | Ambisome 5 mg/kg twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week during induction chemotherapy |
| Placebo | DRUG | Placebo to match liposomal amphotericin B administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy |
| 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 |
| 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 |
Inclusion Criteria: * HIV infected adults (age greater or equal to 18), on ART or no ART * Definitive talaromycosis confirmed by microscopy, histology, or culture Exclusion Criteria: * Known severe allergy to AmB or 5FC * Absolute neutrophil count \<500 cells * Concurrent cryptococcal or TB menin...
Liposomal amphotericin B and stibogluconate is studied for invasive fungal disease, primary visceral leishmaniasis, and talaromycosis. The combination pairs liposomal amphotericin B with sodium stibogluconate, an antimony compound, and has been evaluated in a Phase 2 trial for visceral leishmaniasis in eastern Africa and in Phase 3 studies for fungal infections.
Gilead Sciences, Inc. (ticker GILD) develops liposomal amphotericin B, marketed as AmBisome. Sodium stibogluconate is a separate antileishmanial agent used in combination regimens. The combined liposomal amphotericin B and stibogluconate strategy has been investigated in company-sponsored and investigator-led trials for leishmaniasis and fungal disease.
Liposomal amphotericin B and stibogluconate is in Phase 3 development. A Phase 3 trial, NCT06525389, is not yet recruiting and will enroll 428 participants with talaromycosis in the United States and Vietnam. A completed Phase 3 trial, NCT01259713, studied prevention of invasive fungal infections in patients receiving chemotherapy for acute lymphoblastic leukemia.
The main active trial is NCT06525389, a Phase 3, randomized, double-blind, placebo-controlled study of liposomal amphotericin B and flucytosine for talaromycosis, with 428 planned participants in the United States and Vietnam. Completed studies include NCT01259713 in invasive fungal disease and NCT01067443, a Phase 2 trial in primary visceral leishmaniasis in Kenya and Sudan.
Yes, AmBisome is a brand name for liposomal amphotericin B. The combination regimen is also referred to as liposomal amphotericin B and sodium stibogluconate, or LAmB. These names describe the same liposomal amphotericin B component used with sodium stibogluconate in the studied combination.