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

NCT05551273 | Completed Phase 2 FDA Drug

• 1 other identifier: A5394
• Study Type: interventional
• Target: 29
• Locations: 4 countries
• Sites: 12

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.

Conditions

HIV Infections; Hepatitis B

Outcome Measures

Primary Outcomes (3)

• Proportion of participants who experienced adverse events (AEs)

  From study treatment initiation to Week 24

• Proportion of participants who prematurely discontinued treatment due to adverse events (AEs)

  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

  At week 24

Secondary Outcomes (10)

• Proportion of participants with ≥1 log10 IU/mL decline from baseline in qHBsAg at any time during the study after SLGN treatment Initiation

  Baseline though week 48

• Proportion of participants with ≥0.5 log10 IU/mL decline from baseline in qHBsAg after SLGN treatment at Week 24

  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

  Baseline though week 48

• Proportion of participants who achieve HBsAg loss after SLGN initiation and who sustain HBsAg loss during follow-up

  Baseline though week 48

• Changes from baseline in qHBsAg levels at Weeks 4, 12, 24, 36, and 48

  At week 4, 12, 24, 36 and 48

Study Arms (2)

Arm A

EXPERIMENTAL

Selgantolimod 3 mg once weekly for 24 weeks

Drug: Selgantolimod

Arm B

PLACEBO COMPARATOR

Matching Placebo for Selgantolimod once weekly for 24 weeks

Drug: Placebo

Interventions

Selgantolimod DRUG

1.5 mg tablet

Arm A

Placebo DRUG

Matching placebo tablet

Arm B

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (12)

UCSD Antiviral Research Center CRS (Site 701)

San Diego, California, 92103, United States

Location

The Ponce de Leon Center CRS (Site 5802)

Atlanta, Georgia, 30308, United States

Location

Weill Cornell Chelsea CRS (Site 7804)

New York, New York, 10011, United States

Location

Greensboro CRS (Site# 3203)

Greensboro, North Carolina, 27401, United States

Location

Cincinnati Clinical Research Site (Site 2401)

Cincinnati, Ohio, 45267-0405, United States

Location

Case CRS (Site ID# 2501)

Cleveland, Ohio, 44106, United States

Location

Univ of Pittsburgh (Site 1001)

Pittsburgh, Pennsylvania, 15213, United States

Location

Instituto de Pesquisas em AIDS do Rio Grande do Sul - IPARGS CRS (Site 12201)

Porto Alegre, Rio Grande do Sul, 91350-180, Brazil

Location

Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS (Site ID# 12101)

Rio de Janeiro, 21040-360, Brazil

Location

Barranco CRS (Site 11301)

Lima, 04, Peru

Location

Thai Red Cross AIDS Research Centre (TRC-ARC) CRS (Site 31802)

Pathum Wan, Bangkok, 10330, Thailand

Location

Chiang Mai University HIV Treatment (CMU HIV Treatment) CRS (Site 31784)

Chiang Mai, 50200, Thailand

Location

MeSH Terms

Conditions

Hepatitis B; HIV Infections

Interventions

selgantolimod

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2022
• First Posted: September 22, 2022
• Study Start: May 5, 2023
• Primary Completion: October 29, 2025
• Study Completion: April 8, 2026
• Last Updated: May 26, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 3 months following publication and available throughout period of funding of the AIDS Clinical Trials Group by NIH
• Access Criteria: With whom? Researchers who provide a methodologically sound proposal for use of the data that is approved by the AIDS Clinical Trials Group. For what types of analyses? To achieve aims in the proposal approved by the AIDS Clinical Trials Group. By what mechanism will data be made available? Researchers may submit a request for access to data using the AIDS Clinical Trials Group "Data Request" form at: https://actgnetwork.org/submit-a-proposal/. Researchers of approved proposals will need to sign an AIDS Clinical Trials Group Data Use Agreement before receiving the data

Locations

PE (1); US (7); BR (2); TH (2)