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Also known as Liposomal Amphotericin B (LAmB)
Liposomal Amphotericin B · 2 trials · 2 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 |
| 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 |
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 is an investigational small molecule being studied for the treatment of invasive fungal disease and talaromycosis. It is currently in Phase 3 clinical development for these infectious disease indications.
Liposomal Amphotericin B is being developed by Gilead Sciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol GILD.
Liposomal Amphotericin B is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities for the indications under study.
Liposomal Amphotericin B is being evaluated in two Phase 3 trials. NCT01259713, a completed study in the United Kingdom, assessed prevention of invasive fungal infections in 355 patients receiving chemotherapy for acute lymphoblastic leukemia. NCT06525389, not yet recruiting, will study the drug with flucytosine for talaromycosis in 428 patients in the United States and Vietnam.
Yes, Liposomal Amphotericin B is also known as LAmB. Both names refer to the same investigational drug being developed by Gilead Sciences for invasive fungal disease and talaromycosis.