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New drug aims to tame hepatitis b in HIV patients

NCT ID NCT05551273

Disease control Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This Phase 2 trial tested an oral drug called selgantolimod in 29 adults with both chronic hepatitis B and HIV. Participants had been on stable antiviral therapy for both viruses for at least 5 years. The study aimed to see if the drug is safe and can lower hepatitis B surface antigen levels in the blood, which is a marker of the virus.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Selgantolimod (an oral drug that stimulates the immune system)
What this could lead to
If successful, this could point toward a way to lower hepatitis B virus levels in people who also have HIV, potentially reducing liver damage over time.
What could go wrong
This is a small, early-phase trial focused on safety and immune response, not a cure. The drug may not significantly reduce hepatitis B markers, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

29 people

The number who actually took part.

Started

May 2023

Finished

Apr 2026

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

hepatitis B virus infection HIV infectious disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hepatitis B HIV infections

Contacts and locations

Locations

  • Barranco CRS (Site 11301)

    Lima, 04, Peru

  • Case CRS (Site ID# 2501)

    Cleveland, Ohio, 44106, United States

  • Chiang Mai University HIV Treatment (CMU HIV Treatment) CRS (Site 31784)

    Chiang Mai, 50200, Thailand

  • Cincinnati Clinical Research Site (Site 2401)

    Cincinnati, Ohio, 45267-0405, United States

  • Greensboro CRS (Site# 3203)

    Greensboro, North Carolina, 27401, United States

  • Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS (Site ID# 12101)

    Rio de Janeiro, 21040-360, Brazil

  • Instituto de Pesquisas em AIDS do Rio Grande do Sul - IPARGS CRS (Site 12201)

    Porto Alegre, Rio Grande do Sul, 91350-180, Brazil

  • Thai Red Cross AIDS Research Centre (TRC-ARC) CRS (Site 31802)

    Pathum Wan, Bangkok, 10330, Thailand

  • The Ponce de Leon Center CRS (Site 5802)

    Atlanta, Georgia, 30308, United States

  • UCSD Antiviral Research Center CRS (Site 701)

    San Diego, California, 92103, United States

  • Univ of Pittsburgh (Site 1001)

    Pittsburgh, Pennsylvania, 15213, United States

  • Weill Cornell Chelsea CRS (Site 7804)

    New York, New York, 10011, United States

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