Open
Actively Recruiting
Study of Oral TLR8 Agonist Selgantolimod on HBsAg in Participants With Both Chronic Hepatitis B and HIV
About
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.
Primary Purpose
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
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.
- 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.
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
- 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
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Study Stats
Protocol No.
22-5064
Category
Infectious Diseases
Principal Investigator
