Hepatitis BPhase 2NCT05551273
Study of Oral TLR8 Agonist Selgantolimod on HBsAg in Participants With Both Chronic Hepatitis B and HIV
A Phase 2 study testing Selgantolimod in people with Hepatitis B and HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 12 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatitis B, HIV Infections
- What is being tested?
- Selgantolimod
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 12 sitesin 4 countries
- Study dates
- 5 May 2023to 8 Apr 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- Presence of any active or acute AIDS-defining opportunistic infections within 60 days prior to study entry
- History of uveitis or posterior synechiae
- Breastfeeding
Trial locations and contacts
12 sites in 4 countries.
12 sites in 4 countries
United States7 sites
The Ponce de Leon Center CRS (Site 5802)
Atlanta, Georgia, 30308
Cincinnati Clinical Research Site (Site 2401)
Cincinnati, Ohio, 45267-0405
Case CRS (Site ID# 2501)
Cleveland, Ohio, 44106
Greensboro CRS (Site# 3203)
Greensboro, North Carolina, 27401
Weill Cornell Chelsea CRS (Site 7804)
New York, New York, 10011
Univ of Pittsburgh (Site 1001)
Pittsburgh, Pennsylvania, 15213
UCSD Antiviral Research Center CRS (Site 701)
San Diego, California, 92103
Brazil2 sites
Instituto de Pesquisas em AIDS do Rio Grande do Sul - IPARGS CRS (Site 12201)
Porto Alegre, Rio Grande do Sul, 91350-180
Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS (Site ID# 12101)
Rio de Janeiro, 21040-360
Thailand2 sites
Chiang Mai University HIV Treatment (CMU HIV Treatment) CRS (Site 31784)
Chiang Mai, 50200
Thai Red Cross AIDS Research Centre (TRC-ARC) CRS (Site 31802)
Pathum Wan, Bangkok, 10330
About this study
Official title: Safety, Tolerability, and Impact 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) 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.
Read the detailed description
A5394 is a phase II, double-blinded, placebo-controlled trial. Forty-eight study participants will be randomized 3:1 to receive SLGN or its placebo (36 active and 12 placebo), and randomization will be stratified by HBeAg status. One-half of the study participants will be HBeAg positive (n=24) at screening, and the other half will be HBeAg negative (n=24). All participants will remain on their non-study-provided antiviral therapy throughout the study.
- Conditions
- Hepatitis B, HIV Infections
- Being tested
- Selgantolimod, Placebo
- Medical subject headings
- Hepatitis B, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SelgantolimodDrug
1.5 mg tablet
PlaceboDrug
Matching placebo tablet
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Selgantolimod 3 mg once weekly for 24 weeks Receives: Drug: Selgantolimod |
| Arm B | Placebo comparator | Matching Placebo for Selgantolimod once weekly for 24 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants who experienced adverse events (AEs)
Measured: From study treatment initiation to Week 24
Proportion of participants who prematurely discontinued treatment due to adverse events (AEs)
Measured: From study treatment initiation to Week 24
Proportion of participants with ≥1 log10 IU/mL decline from baseline in quantitative HBsAg (qHBsAg) after SLGN treatment at Week 24
Measured: At week 24
Secondary outcomes (10)
Proportion of participants with ≥1 log10 IU/mL decline from baseline in qHBsAg at any time during the study after SLGN treatment Initiation
Measured: Baseline though week 48
Proportion of participants with ≥0.5 log10 IU/mL decline from baseline in qHBsAg after SLGN treatment at Week 24
Measured: At week 24
Proportion of participants with ≥0.5 log10 IU/mL decline in qHBsAg from baseline at any time during the study after SLGN treatment initiation
Measured: Baseline though week 48
Proportion of participants who achieve HBsAg loss after SLGN initiation and who sustain HBsAg loss during follow-up
Measured: Baseline though week 48
Changes from baseline in qHBsAg levels at Weeks 4, 12, 24, 36, and 48
Measured: At week 4, 12, 24, 36 and 48
Proportion of HBeAg positive participants at baseline who lose HBeAg at any time during the study
Measured: Baseline though week 48
Proportion of anti-HBe negative participants at baseline who develop anti-HBe at any time during the study
Measured: Baseline though week 48
Proportion of hepatitis B surface antibody (anti-HBs) negative participants at baseline who develop anti-HBs at any time during the study
Measured: Baseline though week 48
Detection of plasma HIV RNA >50 copies/mL at weeks 2, 4, 24, and 48
Measured: At Weeks 2, 4, 24 and 48
Detection of serum HBV DNA >50 IU/mL at weeks 2, 4, 24, and 48
Measured: At Weeks 2, 4, 24 and 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start5 May 2023
- Primary completion29 Oct 2025
- Study completion8 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis BStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05551273
- Sponsor's protocol ID
- A5394
- Status last verified
- May 2026
- First submitted
- 9 Sep 2022
- Last updated
- 26 May 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie results in the publication, after deidentification
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability, and Impact of Oral TLR8 Agonist Selgantolimod on HBsAg in Participants With Both Chronic Hepatitis B and HIV
- ClinicalTrials.gov ID
- NCT05551273
- Acronym / sponsor ID
- A5394
- Conditions
- Hepatitis B, HIV Infections
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 5 May 2023 (actual)
- Primary completion
- 29 Oct 2025 (actual)
- Study completion
- 8 Apr 2026 (actual)
- First posted
- 22 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A5394 is a phase II, double-blinded, placebo-controlled trial. Forty-eight study participants will be randomized 3:1 to receive SLGN or its placebo (36 active and 12 placebo), and randomization will be stratified by HBeAg status. One-half of the study participants will be HBeAg positive (n=24) at screening, and the other half will be HBeAg negative (n=24). All participants will remain on their non-study-provided antiviral therapy throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: SelgantolimodSelgantolimod 3 mg once weekly for 24 weeks |
| Arm B | Placebo comparator | Drug: PlaceboMatching Placebo for Selgantolimod once weekly for 24 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Selgantolimod1.5 mg tablet | Drug | Arm A |
| PlaceboMatching placebo tablet | Drug | Arm B |
Primary outcome
Proportion of participants who experienced adverse events (AEs)
Time frame: From study treatment initiation to Week 24
Proportion of participants who prematurely discontinued treatment due to adverse events (AEs)
Time frame: From study treatment initiation to Week 24
Proportion of participants with ≥1 log10 IU/mL decline from baseline in quantitative HBsAg (qHBsAg) after SLGN treatment at Week 24
Time frame: At week 24
10 secondary outcomes
Proportion of participants with ≥1 log10 IU/mL decline from baseline in qHBsAg at any time during the study after SLGN treatment Initiation
Time frame: Baseline though week 48
Proportion of participants with ≥0.5 log10 IU/mL decline from baseline in qHBsAg after SLGN treatment at Week 24
Time frame: At week 24
Proportion of participants with ≥0.5 log10 IU/mL decline in qHBsAg from baseline at any time during the study after SLGN treatment initiation
Time frame: Baseline though week 48
Proportion of participants who achieve HBsAg loss after SLGN initiation and who sustain HBsAg loss during follow-up
Time frame: Baseline though week 48
Changes from baseline in qHBsAg levels at Weeks 4, 12, 24, 36, and 48
Time frame: At week 4, 12, 24, 36 and 48
Proportion of HBeAg positive participants at baseline who lose HBeAg at any time during the study
Time frame: Baseline though week 48
Proportion of anti-HBe negative participants at baseline who develop anti-HBe at any time during the study
Time frame: Baseline though week 48
Proportion of hepatitis B surface antibody (anti-HBs) negative participants at baseline who develop anti-HBs at any time during the study
Time frame: Baseline though week 48
Detection of plasma HIV RNA >50 copies/mL at weeks 2, 4, 24, and 48
Time frame: At Weeks 2, 4, 24 and 48
Detection of serum HBV DNA >50 IU/mL at weeks 2, 4, 24, and 48
Time frame: At Weeks 2, 4, 24 and 48
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie results in the publication, after deidentification
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Selgantolimod in people with Hepatitis B and HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 12 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Brazil, Thailand, Peru. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants who experienced adverse events (AEs) (time frame: From study treatment initiation to Week 24). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.