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

Completed · Phase 2 · Has a placebo group

Conditions studied: Hepatitis B, HIV Infections

In brief

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.

Key facts

Study ID

NCT05551273

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

29

Starts

2023-05-05

Expected to finish

2026-04-08

Last updated by the study team

2026-05-26

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

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
• 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

Where it is running

• UCSD Antiviral Research Center CRS (Site 701) — San Diego, California, United States
• The Ponce de Leon Center CRS (Site 5802) — Atlanta, Georgia, United States
• Weill Cornell Chelsea CRS (Site 7804) — New York, New York, United States
• Greensboro CRS (Site# 3203) — Greensboro, North Carolina, United States
• Cincinnati Clinical Research Site (Site 2401) — Cincinnati, Ohio, United States
• Case CRS (Site ID# 2501) — Cleveland, Ohio, United States
• Univ of Pittsburgh (Site 1001) — Pittsburgh, Pennsylvania, United States
• Instituto de Pesquisas em AIDS do Rio Grande do Sul - IPARGS CRS (Site 12201) — Porto Alegre, Rio Grande do Sul, Brazil
• Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS (Site ID# 12101) — Rio de Janeiro, Brazil
• Barranco CRS (Site 11301) — Lima, Peru
• Thai Red Cross AIDS Research Centre (TRC-ARC) CRS (Site 31802) — Pathum Wan, Bangkok, Thailand
• Chiang Mai University HIV Treatment (CMU HIV Treatment) CRS (Site 31784) — Chiang Mai, Thailand

Full record on ClinicalTrials.gov

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