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

Primary Purpose

Hepatitis B, HIV Infections

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Selgantolimod
Placebo
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis B

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Alabama CRS
  • UCSD Antiviral Research Center CRSRecruiting
  • Univ of California, San FranciscoRecruiting
  • Harbor-UCLA Med. Ctr. CRS (Site ID: 603)
  • University of Colorado Hospital CRSRecruiting
  • Whitman-Walker Health CRS
  • The Ponce de Leon Center CRS
  • Northwestern University CRSRecruiting
  • Johns Hopkins University CRS
  • Massachusetts General Hospital CRS (MGH CRS)
  • Washington University Therapeutics (WT) CRS
  • New Jersey Medical School Clinical Research Center CRS
  • Weill Cornell Chelsea CRSRecruiting
  • Columbia P&S CRS
  • Weill Cornell Uptown CRS
  • University of Rochester Adult HIV Therapeutic Strategies Network CRS
  • Chapel Hill CRS
  • Greensboro CRS
  • Cincinnati Children's Hosp / Univ Hosp
  • Case CRS
  • Ohio State University CRS
  • Penn Therapeutics CRS
  • Univ of PittsburghRecruiting
  • Vanderbilt Therapeutics (VT) CRS
  • Houston AIDS Research Team CRS
  • University of Washington AIDS CRS
  • Gaborone CRS
  • Hospital Nossa Senhora da Conceicao CRS
  • Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS
  • GHESKIO Institute of Infectious Diseases and Reproductive Health (GHESKIO - IMIS) CRS
  • Barranco CRS
  • De La Salle Health Science Institute Angelo King Medical Research Center (DLSHSI-AKMRC)
  • Soweto ACTG CRS
  • Durban International CRS
  • Thai Red Cross AIDS Research Centre (TRC-ARC) CRS
  • Chiang Mai University HIV Treatment (CMU HIV Treatment) CRS
  • Joint Clinical Research Centre (JCRC)/Kampala Clinical Research Site
  • Milton Park CRS

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm A

Arm B

Arm Description

Selgantolimod 3 mg once weekly for 24 weeks

Matching Placebo for Selgantolimod once weekly for 24 weeks

Outcomes

Primary Outcome Measures

Proportion of participants who experienced adverse events (AEs)
Proportion of participants who prematurely discontinued treatment due to adverse events (AEs)
Proportion of participants with ≥1 log10 IU/mL decline from baseline in quantitative HBsAg (qHBsAg) after SLGN treatment at Week 24

Secondary Outcome Measures

Proportion of participants with ≥1 log10 IU/mL decline from baseline in qHBsAg at any time during the study after SLGN treatment Initiation
Proportion of participants with ≥0.5 log10 IU/mL decline from baseline in qHBsAg after SLGN treatment 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
Proportion of participants who achieve HBsAg loss after SLGN initiation and who sustain HBsAg loss during follow-up
Changes from baseline in qHBsAg levels at Weeks 4, 12, 24, 36, and 48
Proportion of HBeAg positive participants at baseline who lose HBeAg at any time during the study
Proportion of anti-HBe negative participants at baseline who develop anti-HBe at any time during the study
Proportion of hepatitis B surface antibody (anti-HBs) negative participants at baseline who develop anti-HBs at any time during the study
Detection of plasma HIV RNA >50 copies/mL at weeks 2, 4, 24, and 48
Detection of serum HBV DNA >50 IU/mL at weeks 2, 4, 24, and 48

Full Information

First Posted
September 9, 2022
Last Updated
July 21, 2023
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT05551273
Brief Title
Study of Oral TLR8 Agonist Selgantolimod on HBsAg in Participants With Both Chronic Hepatitis B and HIV
Official Title
Safety, Tolerability, and Impact of Oral TLR8 Agonist Selgantolimod on HBsAg in Participants With Both Chronic Hepatitis B and HIV
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 5, 2023 (Actual)
Primary Completion Date
January 19, 2025 (Anticipated)
Study Completion Date
July 17, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B, HIV Infections

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A
Arm Type
Experimental
Arm Description
Selgantolimod 3 mg once weekly for 24 weeks
Arm Title
Arm B
Arm Type
Placebo Comparator
Arm Description
Matching Placebo for Selgantolimod once weekly for 24 weeks
Intervention Type
Drug
Intervention Name(s)
Selgantolimod
Intervention Description
1.5 mg tablet
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo tablet
Primary Outcome Measure Information:
Title
Proportion of participants who experienced adverse events (AEs)
Time Frame
From study treatment initiation to Week 24
Title
Proportion of participants who prematurely discontinued treatment due to adverse events (AEs)
Time Frame
From study treatment initiation to Week 24
Title
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 Measure Information:
Title
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
Title
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
Title
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
Title
Proportion of participants who achieve HBsAg loss after SLGN initiation and who sustain HBsAg loss during follow-up
Time Frame
Baseline though week 48
Title
Changes from baseline in qHBsAg levels at Weeks 4, 12, 24, 36, and 48
Time Frame
At week 4, 12, 24, 36 and 48
Title
Proportion of HBeAg positive participants at baseline who lose HBeAg at any time during the study
Time Frame
Baseline though week 48
Title
Proportion of anti-HBe negative participants at baseline who develop anti-HBe at any time during the study
Time Frame
Baseline though week 48
Title
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
Title
Detection of plasma HIV RNA >50 copies/mL at weeks 2, 4, 24, and 48
Time Frame
At Weeks 2, 4, 24 and 48
Title
Detection of serum HBV DNA >50 IU/mL at weeks 2, 4, 24, and 48
Time Frame
At Weeks 2, 4, 24 and 48

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer Price, MD, PhD
Phone
415-502-1429
Email
jennifer.price@ucsf.edu
Facility Information:
Facility Name
Alabama CRS
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35222
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Faye Heard, M.P.H.
Phone
205-996-4405
Email
fhoward@uabmc.edu
Facility Name
UCSD Antiviral Research Center CRS
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Individual Site Status
Recruiting
Facility Name
Univ of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Individual Site Status
Recruiting
Facility Name
Harbor-UCLA Med. Ctr. CRS (Site ID: 603)
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mario Guerrero
Phone
424-201-3000
Ext
7318
Email
mguerrero@lundquist.org
Facility Name
University of Colorado Hospital CRS
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Name
Whitman-Walker Health CRS
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20005
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Avery Anna Wimpelberg, B.A., CCRC
Phone
202-797-3589
Email
AWimpelberg@whitman-walker.org
Facility Name
The Ponce de Leon Center CRS
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Northwestern University CRS
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Name
Johns Hopkins University CRS
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Massachusetts General Hospital CRS (MGH CRS)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Washington University Therapeutics (WT) CRS
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
New Jersey Medical School Clinical Research Center CRS
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Weill Cornell Chelsea CRS
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
Individual Site Status
Recruiting
Facility Name
Columbia P&S CRS
City
New York
State/Province
New York
ZIP/Postal Code
10032-3732
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Weill Cornell Uptown CRS
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
University of Rochester Adult HIV Therapeutic Strategies Network CRS
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susan Hulse
Phone
585-275-0529
Email
susan_hulse@urmc.rochester.edu
Facility Name
Chapel Hill CRS
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Greensboro CRS
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27401
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Cincinnati Children's Hosp / Univ Hosp
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
452292899
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Case CRS
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Ohio State University CRS
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Penn Therapeutics CRS
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jamie Doyle, MPH, CCRC
Phone
215-615-2316
Email
Jamie.Doyle1@pennmedicine.upenn.edu
Facility Name
Univ of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Recruiting
Facility Name
Vanderbilt Therapeutics (VT) CRS
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37204
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Houston AIDS Research Team CRS
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Laura Martinez
Phone
713-500-6718
Email
Maria.L.Martinez@uth.tmc.edu
Facility Name
University of Washington AIDS CRS
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104-9929
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Gaborone CRS
City
Gaborone
State/Province
South-East District
Country
Botswana
Individual Site Status
Not yet recruiting
Facility Name
Hospital Nossa Senhora da Conceicao CRS
City
Porto Alegre
ZIP/Postal Code
91350-200
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Name
Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS
City
Rio de Janeiro
ZIP/Postal Code
21040-360
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Name
GHESKIO Institute of Infectious Diseases and Reproductive Health (GHESKIO - IMIS) CRS
City
Port-au-Prince
ZIP/Postal Code
HT-6110
Country
Haiti
Individual Site Status
Not yet recruiting
Facility Name
Barranco CRS
City
Lima
ZIP/Postal Code
04
Country
Peru
Individual Site Status
Not yet recruiting
Facility Name
De La Salle Health Science Institute Angelo King Medical Research Center (DLSHSI-AKMRC)
City
Cavite
ZIP/Postal Code
4114
Country
Philippines
Individual Site Status
Not yet recruiting
Facility Name
Soweto ACTG CRS
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
1862
Country
South Africa
Individual Site Status
Not yet recruiting
Facility Name
Durban International CRS
City
Durban
ZIP/Postal Code
4091
Country
South Africa
Individual Site Status
Not yet recruiting
Facility Name
Thai Red Cross AIDS Research Centre (TRC-ARC) CRS
City
Pathum Wan
State/Province
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Individual Site Status
Not yet recruiting
Facility Name
Chiang Mai University HIV Treatment (CMU HIV Treatment) CRS
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
Individual Site Status
Not yet recruiting
Facility Name
Joint Clinical Research Centre (JCRC)/Kampala Clinical Research Site
City
Kampala
Country
Uganda
Individual Site Status
Not yet recruiting
Facility Name
Milton Park CRS
City
Milton Park
State/Province
Harare
Country
Zimbabwe
Individual Site Status
Not yet recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie results in the publication, after deidentification
IPD Sharing Time Frame
Beginning 3 months following publication and available throughout period of funding of the AIDS Clinical Trials Group by NIH
IPD Sharing 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

Learn more about this trial

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

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