Liposomal Amphotericin B + Flucytosine for Fungal Infection

(LAmB-FAST Trial)

This trial aims to find better ways to treat talaromycosis, a fungal infection, in people with HIV. It will test whether a single dose of liposomal amphotericin B (an antifungal medicine) is more effective than the standard 14-day treatment. The trial will also evaluate if adding flucytosine (another antifungal drug) improves treatment outcomes. Additionally, it will explore whether monitoring HIV levels can guide when to stop itraconazole to prevent the infection's recurrence. People with HIV diagnosed with talaromycosis are suitable candidates for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

The trial information does not specify if you need to stop taking your current medications. However, it does mention that participants should not have received more than 2 doses of conventional amphotericin B, which might imply some restrictions on similar treatments.

Research has shown that liposomal amphotericin B (LAmB) is generally safe for treating fungal infections. The FDA has approved it for certain infections, indicating it has passed strict safety tests for those uses. Studies suggest that LAmB may be less harmful than an older version, deoxycholate amphotericin B (DAmB). Specifically, LAmB is associated with a 24.8% mortality rate over ten weeks, one of the lowest rates observed in similar research.

Researchers have also studied deoxycholate amphotericin B combined with flucytosine, finding that this combination improves survival rates in fungal infections. However, DAmB can sometimes cause side effects like kidney problems or anemia (a low red blood cell count). Doctors often follow specific procedures to minimize these risks.

Researchers are excited about these treatments because Liposomal Amphotericin B (LAmB) plus Flucytosine (5FC) and Deoxycholate Amphotericin B (DAmB) plus 5FC offer unique approaches to treating fungal infections. Unlike traditional treatments that often require longer durations, LAmB delivers a high dose in a single infusion, potentially reducing treatment time and side effects. Meanwhile, DAmB plus 5FC provides an alternative with a different formulation of Amphotericin B, which might improve patient outcomes by enhancing the effectiveness of the antifungal combination. Both treatments aim to target the fungal infection more effectively, which could lead to quicker recovery and fewer complications for patients.

Research has shown that a single 10 mg/kg dose of liposomal amphotericin B matches the effectiveness of the traditional 14-day treatment with deoxycholate amphotericin B for fungal infections. This trial evaluates both liposomal and deoxycholate amphotericin B, with some participants receiving flucytosine and others a placebo. Adding flucytosine to amphotericin B can further improve survival rates in patients with severe fungal infections. These treatments have demonstrated good results, especially for widespread fungal infections. Both liposomal and deoxycholate amphotericin B, particularly when combined with flucytosine, effectively clear fungal infections and help patients live longer.²³⁴⁶⁷