Study of Oral TLR8 Agonist Selgantolimod on HBsAg in Participants With Both Chronic Hepatitis B and HIV
NCT ID: NCT05551273
Last Updated: 2025-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
29 participants
INTERVENTIONAL
2023-05-05
2026-04-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Arm A
Selgantolimod 3 mg once weekly for 24 weeks
Selgantolimod
1.5 mg tablet
Arm B
Matching Placebo for Selgantolimod once weekly for 24 weeks
Placebo
Matching placebo tablet
Interventions
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Selgantolimod
1.5 mg tablet
Placebo
Matching placebo tablet
Eligibility Criteria
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Inclusion Criteria
2. 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.
3. CD4+ cell count ≥350 cells/mm3
4. 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.
5. Positive or negative HBeAg
6. Negative anti-HDV
7. Current CHB infection
8. 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.
9. Quantitative HBsAg \>1000 IU/mL
10. Hepatitis C virus (HCV) antibody negative, or if the participant is HCV antibody positive, an undetectable HCV RNA.
11. Participants age ≥18 years and ≤70 years at study entry
12. Participants must agree to stay on an effective antiviral therapy for HIV (ART) and HBV throughout the study.
Exclusion Criteria
2. Evidence of advanced fibrosis or cirrhosis (Metavir ≥F3 or equivalent).
3. Current or prior history of clinical hepatic decompensation (e.g., ascites, encephalopathy, or variceal hemorrhage)
4. History of HCC or cholangiocarcinoma
5. 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.
6. History of solid organ transplantation
7. Presence of any active or acute AIDS-defining opportunistic infections within 60 days prior to study entry
8. History of uveitis or posterior synechiae
9. Breastfeeding
18 Years
70 Years
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Locations
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Alabama CRS
Birmingham, Alabama, United States
UCSD Antiviral Research Center CRS
San Diego, California, United States
The Ponce de Leon Center CRS
Atlanta, Georgia, United States
Northwestern University CRS
Chicago, Illinois, United States
Weill Cornell Chelsea CRS
New York, New York, United States
Columbia P&S CRS
New York, New York, United States
Weill Cornell Uptown CRS
New York, New York, United States
Chapel Hill CRS
Chapel Hill, North Carolina, United States
Greensboro CRS Site# 3203
Greensboro, North Carolina, United States
Cincinnati Children's Hosp / Univ Hosp
Cincinnati, Ohio, United States
Case CRS Site ID# 2501
Cleveland, Ohio, United States
Ohio State University CRS
Columbus, Ohio, United States
Univ of Pittsburgh
Pittsburgh, Pennsylvania, United States
Vanderbilt Therapeutics (VT) CRS
Nashville, Tennessee, United States
Houston AIDS Research Team CRS
Houston, Texas, United States
University of Washington AIDS CRS
Seattle, Washington, United States
Hospital Nossa Senhora da Conceicao CRS
Porto Alegre, , Brazil
Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS Site ID# 12101
Rio de Janeiro, , Brazil
Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS
Rio de Janeiro, , Brazil
GHESKIO Institute of Infectious Diseases and Reproductive Health (GHESKIO - IMIS) CRS
Port-au-Prince, , Haiti
Barranco CRS
Lima, , Peru
De La Salle Health Science Institute Angelo King Medical Research Center (DLSHSI-AKMRC)
Cavite, , Philippines
Soweto ACTG CRS
Johannesburg, Gauteng, South Africa
Thai Red Cross AIDS Research Centre (TRC-ARC) CRS
Pathum Wan, Bangkok, Thailand
Chiang Mai University HIV Treatment (CMU HIV Treatment) CRS
Chiang Mai, , Thailand
Milton Park CRS
Milton Park, Harare, Zimbabwe
Countries
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Other Identifiers
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A5394
Identifier Type: -
Identifier Source: org_study_id