Summary

Eligibility
for people ages 18-70 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around
Principal Investigator
by Jennifer Price, MD, PhD
Headshot of Jennifer Price
Jennifer Price

Description

Summary

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.

Official Title

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

Details

A5394 is a phase II, double-blinded, placebo-controlled trial. Forty-eight study participants will be randomized 3:1 to receive SLGN or its placebo (36 active and 12 placebo), and randomization will be stratified by HBeAg status. One-half of the study participants will be HBeAg positive (n=24) at screening, and the other half will be HBeAg negative (n=24). All participants will remain on their non-study-provided antiviral therapy throughout the study.

Keywords

Hepatitis B, HIV Infections, Hepatitis A, Chronic Hepatitis B, Hepatitis, Selgantolimod

Eligibility

Locations

  • UCSF HIV/AIDS CRS (801) accepting new patients
    San Francisco California 94143 United States
  • Harbor-UCLA Med. Ctr. CRS (Site ID: 603) not yet accepting patients
    Torrance California 90502 United States
  • UCSD Antiviral Research Center CRS accepting new patients
    San Diego California 92103 United States

Lead Scientist at UCSF

  • Jennifer Price, MD, PhD
    Professor, Medicine, School of Medicine. Authored (or co-authored) 112 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
ID
NCT05551273
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 48 study participants
Last Updated