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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05551273
Recruitment Status : Recruiting
First Posted : September 22, 2022
Last Update Posted : May 23, 2023
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hepatitis B HIV Infections Drug: Selgantolimod Drug: Placebo Phase 2

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Safety, Tolerability, and Impact of Oral TLR8 Agonist Selgantolimod on HBsAg in Participants With Both Chronic Hepatitis B and HIV
Actual Study Start Date : May 5, 2023
Estimated Primary Completion Date : March 12, 2024
Estimated Study Completion Date : November 2, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm A
Selgantolimod 3 mg once weekly for 24 weeks
 Drug: Selgantolimod
1.5 mg tablet
Placebo Comparator: Arm B
Matching Placebo for Selgantolimod once weekly for 24 weeks
 Drug: Placebo
Matching placebo tablet


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of participants who experienced adverse events (AEs) [ Time Frame: From study treatment initiation to Week 24 ]
  2. Proportion of participants who prematurely discontinued treatment due to adverse events (AEs) [ Time Frame: 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 [ Time Frame: At week 24 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. Proportion of participants who achieve HBsAg loss after SLGN initiation and who sustain HBsAg loss during follow-up [ Time Frame: Baseline though week 48 ]
  5. Changes from baseline in qHBsAg levels at Weeks 4, 12, 24, 36, and 48 [ Time Frame: At week 4, 12, 24, 36 and 48 ]
  6. Proportion of HBeAg positive participants at baseline who lose HBeAg at any time during the study [ Time Frame: Baseline though week 48 ]
  7. Proportion of anti-HBe negative participants at baseline who develop anti-HBe at any time during the study [ Time Frame: Baseline though week 48 ]
  8. 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 ]
  9. Detection of plasma HIV RNA >50 copies/mL at weeks 2, 4, 24, and 48 [ Time Frame: At Weeks 2, 4, 24 and 48 ]
  10. Detection of serum HBV DNA >50 IU/mL at weeks 2, 4, 24, and 48 [ Time Frame: At Weeks 2, 4, 24 and 48 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. HIV-1 infection
  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:

  1. Receipt of treatment for HCV within 24 weeks prior to study entry
  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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05551273


Contacts
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Contact: Jennifer Price, MD, PhD 415-502-1429 jennifer.price@ucsf.edu

Locations
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Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
More Information
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Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT05551273    
Other Study ID Numbers: A5394
First Posted: September 22, 2022    Key Record Dates
Last Update Posted: May 23, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data that underlie results in the publication, after deidentification
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Beginning 3 months following publication and available throughout period of funding of the AIDS Clinical Trials Group by NIH
Access Criteria: With whom? Researchers who provide a methodologically sound proposal for use of the data that is approved by the AIDS Clinical Trials Group. For what types of analyses? To achieve aims in the proposal approved by the AIDS Clinical Trials Group. By what mechanism will data be made available? Researchers may submit a request for access to data using the AIDS Clinical Trials Group "Data Request" form at: https://actgnetwork.org/submit-a-proposal/. Researchers of approved proposals will need to sign an AIDS Clinical Trials Group Data Use Agreement before receiving the data

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Infections
Enterovirus Infections
 Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Hepadnaviridae Infections
DNA Virus Infections
Hepatitis, Chronic
Chronic Disease
Disease Attributes
Pathologic Processes