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ACTIVE NOT RECRUITING Phase 2

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

NCT05551273 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • DRUG Placebo
  • DRUG Selgantolimod

Study Locations (20)

Other

  • Hospital Nossa Senhora da Conceicao CRS — Porto Alegre
  • Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS Site ID# 12101 — Rio de Janeiro
  • Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS — Rio de Janeiro
  • GHESKIO Institute of Infectious Diseases and Reproductive Health (GHESKIO - IMIS) CRS — Port-au-Prince

New York

  • Weill Cornell Chelsea CRS — New York
  • Columbia P&S CRS — New York
  • Weill Cornell Uptown CRS — New York

Ohio

  • Cincinnati Children's Hosp / Univ Hosp — Cincinnati
  • Case CRS Site ID# 2501 — Cleveland
  • Ohio State University CRS — Columbus

North Carolina

  • Chapel Hill CRS — Chapel Hill
  • Greensboro CRS Site# 3203 — Greensboro

Alabama

  • Alabama CRS — Birmingham

California

  • UCSD Antiviral Research Center CRS — San Diego

Georgia

  • The Ponce de Leon Center CRS — Atlanta

Illinois

  • Northwestern University CRS — Chicago

Trial Details

FieldValue
Enrollment Target 29 participants
Start Date 2023-05-05
Est. Completion 2026-04-29
Phase Phase 2

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05551273

The ClinicalTrials.gov registry entry for NCT05551273 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 29 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with HIV Infections appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05551273 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Other, New York, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05551273 about?

NCT05551273 is a clinical study titled "Study of Oral TLR8 Agonist Selgantolimod on HBsAg in Participants With Both Chronic Hepatitis B and HIV". 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) ...

What is the current status of trial NCT05551273?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 29 participants. The study started on 2023-05-05. Estimated completion is 2026-04-29.

What conditions does trial NCT05551273 study?

This clinical trial studies the following conditions: HIV Infections, Hepatitis B. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05551273?

The interventions under investigation include: Placebo (DRUG), Selgantolimod (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05551273?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05551273 being conducted?

This trial has 20 study locations across Alabama, California, Georgia, Illinois, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial