Selgantolimod for Chronic Hepatitis B and HIV

Recruiting at 42 trial locations

Overseen By Jennifer Price, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

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

Must be taking: Antivirals

Disqualifiers: Advanced fibrosis, Cirrhosis, Malignancy, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

48 Participants Needed

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. ^{1 2 3 4 5}

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

Exclusion Criteria

Breastfeeding

I have had liver or bile duct cancer.

I have been treated for hepatitis C within the last 6 months.

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 Overview 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.

Participant Groups

Group I: Arm A Experimental Treatment 1 Intervention

Selgantolimod 3 mg once weekly for 24 weeks

Group II: Arm B Placebo Group 1 Intervention

Matching Placebo for Selgantolimod once weekly for 24 weeks

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Zidovudine plus interferon alfa-2b treatment in patients with HIV and chronic active viral hepatitis. Visco, G., Alba, L., Grisetti, S., et al.[2019]

In a pilot study involving 10 anti-HIV positive patients with chronic hepatitis B, interferon alfa was well-tolerated, showing similar safety profiles to those in anti-HIV negative patients.

Treatment with interferon alfa led to significant improvements in hepatitis B markers for some patients, including the disappearance of HBV-DNA and normalization of ALT levels, indicating potential efficacy in managing chronic hepatitis B.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recombinant alpha interferon for chronic hepatitis B in anti-HIV positive patients receiving zidovudine. Marcellin, P., Boyer, N., Colin, JF., et al.[2019]

Approximately 10% of the 36 million people living with HIV globally are also infected with chronic hepatitis B virus (HBV), highlighting the significant overlap between these two infections.

Recent advancements in antiviral treatments for HBV and improved diagnostic tools have transformed the management of patients who are coinfected with HIV and HBV, allowing for better care and outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Care of HIV patients with chronic hepatitis B: updated recommendations from the HIV-Hepatitis B Virus International Panel. Soriano, V., Puoti, M., Peters, M., et al.[2022]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Hepatitis B precore/core promoter mutations in isolates from HBV-monoinfected and HBV-HIV coinfected patients: a 3-yr prospective study. [2010]

2. England pubmed.ncbi.nlm.nih.gov

HIV-1/hepatitis B coinfection. [2007]

3. England pubmed.ncbi.nlm.nih.gov

Zidovudine plus interferon alfa-2b treatment in patients with HIV and chronic active viral hepatitis. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Recombinant alpha interferon for chronic hepatitis B in anti-HIV positive patients receiving zidovudine. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Care of HIV patients with chronic hepatitis B: updated recommendations from the HIV-Hepatitis B Virus International Panel. [2022]