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TLR8 Agonist

Selgantolimod for Chronic Hepatitis B and HIV

Q: What are the prerequisites for becoming a participant in this clinical study?

<p>This clinical trial is recruiting 48 <a href="https://www.withpower.com/clinical-trials/hiv">HIV</a>-positive individuals aged 18 to 70. The inclusion criteria for this study includes having an active HIV infection, a CD4+ cell count of ≥350 cells/mm3, being negative for anti-HDV antibodies, currently experiencing chronic HBV (CHB) infections with an HBV DNA level &#x3C;50 IU/mL on at least two occasions 12 weeks apart in the past year and >1000 IU/mL of quantitive HBsAg, taking effective antiviral therapy such as TDF or TAF plus lamivudine among other combinations for more than 5 years prior to enrolment in the</p>

Phase 2

Recruiting

Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at week 4, 12, 24, 36 and 48

Awards & highlights

Study Summary

This trial will test if the drug Selgantolimod is safe and tolerated when given to people with both hepatitis B and HIV who have been on antiviral therapy for both viruses for at least 5 years. The study will also see if Selgantolimod can reduce the level of hepatitis B surface antigen in the blood.

Who is the study for?

Adults aged 18-70 with chronic Hepatitis B and HIV, on effective antiviral therapy for both for over 5 years, having low HBV DNA levels and high HBsAg levels. They must have a stable immune status (CD4+ count ≥350 cells/mm3) and controlled HIV viral load. Excluded are those with recent HCV treatment, liver cancer or organ transplants, certain infections or advanced liver damage.Check my eligibility

What is being tested?

The trial is testing Selgantolimod, an oral drug that targets the immune system's TLR8 receptor. It's given to participants for 24 weeks to see if it can lower hepatitis B surface antigen levels in people who also have HIV but are already on suppressive antiviral therapy.See study design

What are the potential side effects?

While specific side effects of Selgantolimod aren't listed here, drugs like it may cause flu-like symptoms, gastrointestinal issues, skin reactions or changes in blood tests that monitor liver function.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at week 4, 12, 24, 36 and 48

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at week 4, 12, 24, 36 and 48

This trial's timeline: 3 weeks for screening, Varies for treatment, and at week 4, 12, 24, 36 and 48 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Proportion of participants who experienced adverse events (AEs)

Therapeutic procedure

Proportion of participants with ≥1 log10 IU/mL decline from baseline in quantitative HBsAg (qHBsAg) after SLGN treatment at Week 24

Secondary outcome measures

Changes from baseline in qHBsAg levels at Weeks 4, 12, 24, 36, and 48

Detection of plasma HIV RNA >50 copies/mL at weeks 2, 4, 24, and 48

Hepatitis B Surface Antigens

+7 more

Side effects data

From 2020 Phase 2 trial • 48 Patients • NCT03491553

67%

Nausea

33%

Myalgia

22%

Vomiting

22%

Back pain

22%

Headache

22%

Dyspnoea

22%

Dizziness

22%

Chills

11%

Abdominal distension

11%

Upper respiratory tract infection

11%

Abdominal pain upper

11%

Thirst

11%

Feeling hot

11%

Diarrhoea

11%

Perineal abscess

11%

Skin mass

11%

Menorrhagia

11%

Oropharyngeal pain

11%

Eyelids pruritus

11%

Asthenia

11%

Contusion

11%

Joint stiffness

11%

Nocturia

11%

Lower respiratory tract congestion

11%

Palpitations

11%

Abdominal pain

11%

Hypoaesthesia

100%

80%

60%

40%

20%

Study treatment Arm

Selgantolimod 3 mg: HBeAg-positive CHB Participants

Placebo: HBeAg-positive CHB Participants

Selgantolimod 1.5 mg: HBeAg-negative CHB Participants

Selgantolimod 3 mg: HBeAg-negative CHB Participants

Placebo: HBeAg-negative CHB Participants

Selgantolimod 1.5 mg: HBeAg-positive CHB Participants

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm AExperimental Treatment1 Intervention

Selgantolimod 3 mg once weekly for 24 weeks

Group II: Arm BPlacebo Group1 Intervention

Matching Placebo for Selgantolimod once weekly for 24 weeks

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Selgantolimod

2018

Completed Phase 2

~120

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor

3,270 Previous Clinical Trials

5,485,189 Total Patients Enrolled

17 Trials studying Hepatitis B

9,783 Patients Enrolled for Hepatitis B

Media Library

Selgantolimod (TLR8 Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT05551273 — Phase 2

Hepatitis B Research Study Groups: Arm B, Arm A

Hepatitis B Clinical Trial 2023: Selgantolimod Highlights & Side Effects. Trial Name: NCT05551273 — Phase 2

Selgantolimod (TLR8 Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05551273 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What hazards should be taken into consideration when administering Selgantolimod?

"Selgantolimod's safety is supported by Phase 2 trial data, resulting in a score of two on our team's risk assessment scale. There are no studies that have yet to support its efficacy."

Answered by AI

Is this clinical trial recruiting participants at present?

"The details listed on clinicaltrials.gov suggest that the trial is not actively soliciting participants at this time, as it was first posted in November 23rd 2022 and recently edited on September 20th 2022. However, there are 754 other medical studies currently looking for volunteers to join their trials."

Answered by AI

Are applicants for this study required to be above a certain age threshold?

"Enrolment into this trial is restricted to individuals between the ages of 18 and 70. Alternatively, there are 133 clinical trials available for minors as well as 576 research studies dedicated to those aged 65 or above."

Answered by AI

How many medical centers are offering this research project?

"A total of 24 medical centres are participating in this trial, including Columbia P&S CRS in New york, UCSD Antiviral Research Center CRS in San Diego, and Univ of Pittsburgh. Additionally, there are 21 other sites recruiting patients across the country."

Answered by AI

What are the prerequisites for becoming a participant in this clinical study?

"This clinical trial is recruiting 48 HIV-positive individuals aged 18 to 70. The inclusion criteria for this study includes having an active HIV infection, a CD4+ cell count of ≥350 cells/mm3, being negative for anti-HDV antibodies, currently experiencing chronic HBV (CHB) infections with an HBV DNA level <50 IU/mL on at least two occasions 12 weeks apart in the past year and >1000 IU/mL of quantitive HBsAg, taking effective antiviral therapy such as TDF or TAF plus lamivudine among other combinations for more than 5 years prior to enrolment in the"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Study of Oral TLR8 Agonist Selgantolimod on HBsAg in Participants With Both Chronic Hepatitis B and HIV". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05551273.

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