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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
29
1.5 mg tablet
Matching placebo tablet
UCSD Antiviral Research Center CRS (Site 701)
San Diego, California, United States
The Ponce de Leon Center CRS (Site 5802)
Atlanta, Georgia, United States
Weill Cornell Chelsea CRS (Site 7804)
New York, New York, United States
Greensboro CRS (Site# 3203)
Greensboro, North Carolina, United States
Cincinnati Clinical Research Site (Site 2401)
Cincinnati, Ohio, United States
Case CRS (Site ID# 2501)
Cleveland, Ohio, United States
Univ of Pittsburgh (Site 1001)
Pittsburgh, Pennsylvania, United States
Instituto de Pesquisas em AIDS do Rio Grande do Sul - IPARGS CRS (Site 12201)
Porto Alegre, Rio Grande do Sul, Brazil
Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS (Site ID# 12101)
Rio de Janeiro, Brazil
Barranco CRS (Site 11301)
Lima, Peru
...and 2 more locations
Proportion of participants who experienced adverse events (AEs)
Time frame: From study treatment initiation to Week 24
Proportion of participants who prematurely discontinued treatment due to adverse events (AEs)
Time frame: From study treatment initiation to Week 24
Proportion of participants with ≥1 log10 IU/mL decline from baseline in quantitative HBsAg (qHBsAg) after SLGN treatment at Week 24
Time frame: At week 24
Proportion of participants with ≥1 log10 IU/mL decline from baseline in qHBsAg at any time during the study after SLGN treatment Initiation
Time frame: Baseline though week 48
Proportion of participants with ≥0.5 log10 IU/mL decline from baseline in qHBsAg after SLGN treatment at Week 24
Time frame: At week 24
Proportion of participants with ≥0.5 log10 IU/mL decline in qHBsAg from baseline at any time during the study after SLGN treatment initiation
Time frame: Baseline though week 48
Proportion of participants who achieve HBsAg loss after SLGN initiation and who sustain HBsAg loss during follow-up
Time frame: Baseline though week 48
Changes from baseline in qHBsAg levels at Weeks 4, 12, 24, 36, and 48
Time frame: At week 4, 12, 24, 36 and 48
Proportion of HBeAg positive participants at baseline who lose HBeAg at any time during the study
Time frame: Baseline though week 48
Proportion of anti-HBe negative participants at baseline who develop anti-HBe at any time during the study
Time frame: Baseline though week 48
Proportion of hepatitis B surface antibody (anti-HBs) negative participants at baseline who develop anti-HBs at any time during the study
Time frame: Baseline though week 48
Detection of plasma HIV RNA >50 copies/mL at weeks 2, 4, 24, and 48
Time frame: At Weeks 2, 4, 24 and 48
Detection of serum HBV DNA >50 IU/mL at weeks 2, 4, 24, and 48
Time frame: At Weeks 2, 4, 24 and 48
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.