Zambia study tracks liver health in hepatitis b and HIV patients

NCT ID NCT07589985

Knowledge-focused Sponsor: University of Alabama at Birmingham Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study follows 390 adults in Zambia with hepatitis B, some also with HIV, to see how their liver and immune system change over time. Participants join when diagnosed or starting standard antiviral treatment and are monitored for years. The goal is to learn more about the disease, not to test a new treatment.

What this could mean

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

What this could lead to: If successful, this study could reveal how the immune system controls hepatitis B, pointing toward better treatments or vaccines.
What could go wrong: This is an observational study, not a treatment trial. It will not directly test a new drug or cure, and results may take years to translate into real-world benefits.

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.

Participants

About 390 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2020

Expected to finish

Aug 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Who is studied

This study will occur in Lusaka, Zambia, which has 12% adult HIV prevalence and \~4% adult HBsAg-positivity. Both HIV and HBV treatment are free and provided through the Ministry of Health. Tenofovir-based therapies are used for HBV monoinfection and HBV/HIV coinfection. Potential participants will be recruited from Ministry of Health (i.e., public sector) clinics at study sites including from a pool of participants in past HBV research projects. There are a 5 groups of participants we seek to enroll in the study, to facilitate addressing the scientific goals of the cohort.

Ages

18 years and older

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: Must meet the inclusion criteria for one of 5 groups, as follows: * Group 1 (rx-naive chronic hbv mono): 18+ years old, HBsAg-positive, HIV-negative, eligible for tenofovir-based therapy, reports taking therapy no more than 7 days (could have previously taken if has stopped \>1 year ago). * Group 2 (acute hbv mono): 18+ years old, HBsAg-positive, HIV-negative, acute/subacute onset of hepatitis signs and symptoms and ALT \>10 times upper limit of normal * Group 3 (rx-naive hbv/hiv coinfection): 18+ years old, HBsAg-positive, HIV-negative, eligible for tenofovir-based therapy, reports taking therapy no more than 7 days (could have previously taken if has stopped \>1 year ago). * Group 4 (rx-experienced coinfection with hbv persistence): 18+ years old, history of chronic HBV infection based on two tests 6 months apart, HIV-positive, at least 4 years of tenofovir-based antiviral therapy, currently HBsAg-positive * Group 5 (hbsag loss): 18+ years old, HIV-positive or negative, history of chronic HBV infection based on two tests 6 months apart, Currently HBsAg-negative confirmed by sensitive assay Exclusion Criteria: * Hepatitis C coinfection (antibody-positive and RNA-positive), current or recent (past 6 weeks) pregnancy, decompensated cirrhosis on physical examination, unlikely to remain in Lusaka for study duration

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Acute hepatitis B are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

acute hepatitis B virus infection 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

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

3 sites. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Zambia study tracks liver health in hepatitis b and HIV patients

What the study statuses mean