Fungal Translocation Marker in People Living with HIV Needing Treatment for Onychomycosis: A Protocol for the Prospective Pilot Study

Increased microbial translocation and chronic immune activation are two critical problems for people living with HIV (PLWH) in the antiretroviral therapy (ART) era. Compared with numerous studies on bacterial microbiomic communities, there are only a limited number of studies focusing on fungal microbiomic composition and products in PLWH. This study protocol is used to evaluate the changes in bacterial and fungal microbiome populations induced by terbinafine treatment, which is an antifungal agent widely used amongst PLWH. Twenty-two PLWH on a stable ART regimen for more than six months, who require treatment for onychomycosis, will be recruited. The participants will be followed-up for a 12-week treatment period (oral terbinafine 250 mg daily) and another 12-weeks of terbinafine discontinuation. Plasma and fecal samples will be collected before and after terbinafine treatment, and for 12weeks after the discontinuation of terbinafine. Plasma gut injury and microbial translocation biomarker assays, in addition to testing for gut microbiome composition, will be undertaken. With this pilot study, we will perform formal sample size calculations and test study feasibility for a possible full-scale study.