Safety, Tolerability, and Impact of Oral TLR8 Agonist Selgantolimod on HBsAg in Participants With Both Chronic Hepatitis B and HIV

The study aims to assess safety and tolerability of oral toll-like receptor (TLR) 8 agonist Selgantolimod (SLGN) administered for 24 weeks in participants with both CHB and HIV who have been receiving suppressive antiviral therapy for both viruses for ≥5 years and have qHBsAg level >1000 (3 log10) IU/mL at screening. The study will also evaluate if TLR8 stimulation with SLGN will reduce hepatitis B surface antigen (HBsAg) titers in the blood.

DURATION: December 2022 - Ongoing

STUDY TYPE: HIV & Comorbidities

PHASE: 2

DESIGN: Randomized, parallel assigned, triple masked interventional study

STATUS: Ongoing

ENROLLMENT: ≈48

POPULATION: People living with HIV, age 18 - 70 years older, chronic hepatitis B infection

NUMBER OF SITES: 37

SITE LOCATIONS: US, Botswana, Brazil, Haiti, Peru, Philippines, South Africa, Thailand, Uganda, Zimbabwe

NCT #: NCT05551273

RESULTS