Study of Oral TLR8 Agonist Selgantolimod on HBsAg in Participants With Both Chronic Hepatitis B a… (NCT05551273) | Clinical Trial Compass
CompletedPhase 2
Study of Oral TLR8 Agonist Selgantolimod on HBsAg in Participants With Both Chronic Hepatitis B and HIV
United States29 participantsStarted 2023-05-05
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
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
What they're measuring
1
Proportion of participants who experienced adverse events (AEs)
Timeframe: From study treatment initiation to Week 24
2
Proportion of participants who prematurely discontinued treatment due to adverse events (AEs)
Timeframe: From study treatment initiation to Week 24
3
Proportion of participants with ≥1 log10 IU/mL decline from baseline in quantitative HBsAg (qHBsAg) after SLGN treatment at Week 24
Timeframe: At week 24
Trial details
NCT IDNCT05551273
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
. 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