Summary

Eligibility
for people ages 18-70 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion
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, Hepatitis B, Chronic, Hepatitis, Selgantolimod

Eligibility

You can join if…

Open to people ages 18-70

  1. HIV-1 infection
  2. 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.
  3. CD4+ cell count ≥350 cells/mm3
  4. 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.
  5. Positive or negative HBeAg
  6. Negative anti-HDV
  7. Current CHB infection
  8. 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.
  9. Quantitative HBsAg >1000 IU/mL
  10. . Hepatitis C virus (HCV) antibody negative, or if the participant is HCV antibody positive, an undetectable HCV RNA.
  11. . Participants age ≥18 years and ≤70 years at study entry
  12. . Participants must agree to stay on an effective antiviral therapy for HIV (ART) and HBV throughout the study.

You CAN'T join if...

  1. Receipt of treatment for HCV within 24 weeks prior to study entry
  2. Evidence of advanced fibrosis or cirrhosis (Metavir ≥F3 or equivalent).
  3. Current or prior history of clinical hepatic decompensation (e.g., ascites, encephalopathy, or variceal hemorrhage)
  4. History of HCC or cholangiocarcinoma
  5. 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.
  6. History of solid organ transplantation
  7. Presence of any active or acute AIDS-defining opportunistic infections within 60 days prior to study entry
  8. History of uveitis or posterior synechiae
  9. Breastfeeding

Locations

  • Univ of California, San Francisco
    San Francisco California 94143 United States
  • Harbor-UCLA Med. Ctr. CRS
    Torrance California 90502 United States

Lead Scientist at UCSF

  • Jennifer Price, MD, PhD
    Associate Professor, Medicine, School of Medicine. Authored (or co-authored) 73 research publications

Details

Status
not yet accepting 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