Open Actively Recruiting

Study of Oral TLR8 Agonist Selgantolimod on HBsAg in Participants With Both Chronic Hepatitis B and HIV


Brief 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.

Primary Purpose
Study Type
Phase 2


Healthy Volunteers
Minimum Age
18 Years
Maximum Age
70 Years

Inclusion Criteria:

  • HIV-1 infection
  • Effective antiviral therapy for HIV (ART) and HBV that includes TDF, TAF, TDF/FTC, TDF/3TC (tenofovir disoproxil fumarate plus lamivudine), TAF/FTC, or entecavir (ETV), for ≥5 years immediately prior to study entry. ART is defined as including a minimum of two anti-HIV antivirals.
  • CD4+ cell count ≥350 cells/mm3
  • HIV-1 RNA <50 copies/mL measured on at least two occasions at least 12 weeks apart, with no documented value >200 copies/mL, over the 12 months prior to study entry.
  • Positive or negative HBeAg
  • Negative anti-HDV
  • Current CHB infection
  • HBV DNA level <50 IU/mL measured on at least two occasions at least 12 weeks apart, with no documented value ≥50 IU/mL, over the 12 months prior to study entry.
  • Quantitative HBsAg >1000 IU/mL
  • Hepatitis C virus (HCV) antibody negative, or if the participant is HCV antibody positive, an undetectable HCV RNA.
  • Participants age ≥18 years and ≤70 years at study entry
  • Participants must agree to stay on an effective antiviral therapy for HIV (ART) and HBV throughout the study.

Exclusion Criteria:

  • Receipt of treatment for HCV within 24 weeks prior to study entry
  • Evidence of advanced fibrosis or cirrhosis (Metavir ≥F3 or equivalent).
  • Current or prior history of clinical hepatic decompensation (e.g., ascites, encephalopathy, or variceal hemorrhage)
  • History of HCC or cholangiocarcinoma
  • Malignancy within 5 years prior to study entry. NOTE: A history of non-melanoma skin cancer (e.g., basal cell carcinoma or squamous cell skin cancer) is not exclusionary.
  • History of solid organ transplantation
  • Presence of any active or acute AIDS-defining opportunistic infections within 60 days prior to study entry
  • History of uveitis or posterior synechiae
  • Breastfeeding

Join this Trial

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Study Stats
Protocol No.
Infectious Diseases
  • UCLA Westwood
For Providers
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