48 Participants Needed

Selgantolimod for Chronic Hepatitis B and HIV

Recruiting at 42 trial locations
JP
Overseen ByJennifer Price, MD, PhD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Must be taking: Antivirals
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

This trial tests a pill called Selgantolimod in patients with chronic hepatitis B and HIV who have been on antiviral therapy for an extended period. The pill aims to activate the immune system to reduce the hepatitis B virus levels in their blood.

Will I have to stop taking my current medications?

The trial requires participants to continue their current antiviral therapy for HIV and HBV throughout the study.

What makes the drug Selgantolimod unique for treating chronic hepatitis B and HIV?

Selgantolimod is unique because it is an oral drug that targets the immune system to help control chronic hepatitis B and HIV, unlike traditional treatments that primarily focus on directly attacking the viruses.12345

Eligibility Criteria

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.

Inclusion Criteria

Quantitative HBsAg >1000 IU/mL
My hepatitis B surface antigen status is known.
HIV-1 RNA <50 copies/mL measured on at least two occasions at least 12 weeks apart
See 9 more

Exclusion Criteria

Breastfeeding
I have had liver or bile duct cancer.
I have been treated for hepatitis C within the last 6 months.
See 6 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Selgantolimod or placebo once weekly for 24 weeks

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Selgantolimod
Trial OverviewThe 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.
Participant Groups
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

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

Trials
3,361
Recruited
5,516,000+

Findings from Research

In a 3-year study of 39 patients, HBV isolates from HIV-coinfected individuals showed significantly fewer mutations in the basal core promoter (BCP) region compared to those from HBV-monoinfected patients, suggesting a more stable genomic pattern in the presence of HIV.
The study found that mutations in the precore (Pc) region were rare among all patients and appeared to be dependent on the HBV genotype rather than influenced by HIV co-infection, indicating that the impact of HIV on HBV may vary based on the specific viral strains involved.
Hepatitis B precore/core promoter mutations in isolates from HBV-monoinfected and HBV-HIV coinfected patients: a 3-yr prospective study.Cassino, L., Laufer, N., Salomon, H., et al.[2010]
HIV and hepatitis B coinfection is a significant public health issue, affecting the management and treatment outcomes for individuals with both infections.
Current treatment strategies focus on antiretroviral therapy that is effective against both HIV and hepatitis B, highlighting the importance of integrated care for better patient outcomes.
HIV-1/hepatitis B coinfection.Benhamou, Y.[2007]
In a small study of 11 HIV-positive patients with chronic active viral hepatitis, a low dose combination of zidovudine and interferon alfa-2b led to significant improvements, including reduced liver enzyme levels and increased CD4 lymphocyte counts.
The treatment was well tolerated, with no observed progression of HIV disease, suggesting it may be a safe and effective option for managing both HIV and hepatitis in these patients.
Zidovudine plus interferon alfa-2b treatment in patients with HIV and chronic active viral hepatitis.Visco, G., Alba, L., Grisetti, S., et al.[2019]

References

Hepatitis B precore/core promoter mutations in isolates from HBV-monoinfected and HBV-HIV coinfected patients: a 3-yr prospective study. [2010]
HIV-1/hepatitis B coinfection. [2007]
Zidovudine plus interferon alfa-2b treatment in patients with HIV and chronic active viral hepatitis. [2019]
Recombinant alpha interferon for chronic hepatitis B in anti-HIV positive patients receiving zidovudine. [2019]
Care of HIV patients with chronic hepatitis B: updated recommendations from the HIV-Hepatitis B Virus International Panel. [2022]