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NCT Number: NCT07589985

Hep Mec Cohort in Zambia

Observational cohort of adults with acute and chronic hepatitis B infection in Zambia, with and without HIV coinfection. Participants join the study at the time of diagnosis and before or at the time when they are starting antiviral treatments and then they are followed up over multiple years to assess changes to their liver and evolution of HBV (and HIV if applicable) infection. All treatments for HBV and HIV are standard per local Ministry of Health guidelines.

Recruiting

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Key information

Conditions

Hepatitis B Blood-Borne Infections Communicable Diseases DNA Virus Infections Digestive System Diseases HIV Hepadnaviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kanyama Level 1 Hospital, Lusaka, Zambia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Change in Intrahepatic Immune Cell Subset Frequencies

    Time frame: Baseline and 1 year

    Percentage of immune cell subsets (CD4+ T cells, CD8+ T cells, B cells, NK cells, Macrophages, and Neutrophils) among total liver immune cells as measured by single-cell RNA sequencing. Comparisons will be made between acute and chronic HBV infection, with and without HIV coinfection, and before and after nucleoside analog antiviral therapy.

  2. Number of Differentially Expressed Hepatic Genes Associated with HBsAg Reduction/Loss

    Time frame: Baseline and 1 year

    Count of genes showing differential expression (fold change ≥2.0, adjusted p-value <0.05) by single-cell RNA sequencing in liver biopsies from participants achieving HBsAg loss compared to those without HBsAg loss. Gene expression will be analyzed at baseline (predictive analysis), longitudinally (trajectory analysis), and at end of follow-up. Analysis will include comparison across acute vs. chronic HBV infection and with vs. without HIV coinfection.

Secondary outcomes

  1. HBV viral suppression

    Time frame: Baseline, 1 year, 2 years, 3 years, 4 years, and 5 years

    Reduction of HBV DNA in blood to below detectable levels

  2. HIV viral suppression

    Time frame: Baseline, 1 year, 2 years, 3 years, 4 years, and 5 years

    HIV RNA suppression in blood below the level of assay detection

  3. HBsAg seroclearance

    Time frame: Through study completion, an average of 5 years

    Loss of hepatitis B surface antigen in blood samples

  4. HBeAg seroconversion

    Time frame: Through study completion, an average of 5 years

    HBeAg-negativity in blood

Study contacts

Contact information is provided by the study sponsor or research team.

Ike Oyewole

CONTACT

[email protected]

205-996-0441

Michael J Vinikoor, MD

CONTACT

[email protected]

205-934-5191

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • Centre for Infectious Disease Research in Zambia
  • Massachusetts General Hospital
  • National Institute of Allergy and Infectious Diseases (NIAID)
  • Tropical Gastroenterology and Nutrition Group
  • University of Zambia
  • Weill Medical College of Cornell University

Registry information

Acronym: Hep Mec

Important dates

Study start
2020
Primary completion
2029
Study completion
2030
First posted
May 15, 2026
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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