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

About

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
Treatment
Study Type
Interventional
Phase
Phase II

Eligibility

Gender
All
Healthy Volunteers
No
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

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Study Stats
Protocol No.
22-5064
Category
Infectious Diseases
Location
  • UCLA Westwood
For Providers
NCT No.
NCT05551273
For detailed technical eligibility, visit ClinicalTrials.gov.