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Decade-Long study aims to unlock liver disease risks in HIV-Hepatitis b patients

NCT ID NCT02344680

Knowledge-focused Sponsor: University of Alabama at Birmingham 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 02, 2026 · Last updated Jul 02, 2026

Summary

This study follows adults in Zambia who have both HIV and chronic hepatitis B to track liver health over up to 10 years. Researchers aim to understand how current HIV treatments affect hepatitis B and liver damage, and to identify factors that lead to serious outcomes like liver cancer. The findings could help design future studies aimed at curing hepatitis B.

What this could mean

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

Active substance
Anti-HIV Agents (antiretroviral therapy)
What this could lead to
If successful, this research could identify key risk factors for liver cancer and help design future studies for a hepatitis B cure.
What could go wrong
This is an observational study, not a treatment trial, so it won't directly improve health. Results may take years and might not apply to other populations.

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

349 people

The number who actually took part.

Started

Oct 2015

Finished

May 2026

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

400 adults with HIV-HBV coinfection

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: * Age 18 years or older * Living with HIV infection * Living with active HBV infection, defined as any single positive HBsAg assay * Naïve to antiretroviral therapy or currently participating in HIV/HBV co-infection in IeDEA-SA Exclusion Criteria: * Unable or unwilling to provide informed consent * Planning to relocate out of Lusaka district

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Conditions

The condition(s) this trial relates to.

AIDS alcoholic hepatitis cirrhosis of liver fibrotic liver disease hepatitis B virus infection hepatitis D virus infection hepatocellular carcinoma HIV infectious disease

As listed by the trial registrant

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

Alcoholic hepatitis Cirrhosis, liver Fibrosis, liver HBV Hepatitis delta virus Hepatocellular carcinoma Human immunodeficiency virus

Contacts and locations

Locations

  • Centre for Infectious Disease Research in Zambia (CIDRZ)

    Lusaka, Lusaka Province, 34681, Zambia

More trials for these conditions

Other studies related to the condition(s) this trial covers.