Hepatitis BHep MecNCT07589985
Hep Mec Cohort in Zambia
An observational study of Hepatitis B and HIV, run by University of Alabama at Birmingham at 3 sites in Zambia.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis B, HIV
- How many people
- 390 participants
- Where
- 3 sitesZambia
- Study dates
- 28 Sep 2020to 31 Aug 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Zambia3 sites, 3 recruiting
- Recruiting
Kanyama Level 1 Hospital
Lusaka
Carolyn Chibundi, 260 (contact) 977541659, carolyn.chibundi@cidrz.org
Taonga Musonda, MS, 260 (country) 971964760, taonga@tropgan.com
- Recruiting
Matero Level 1 Hospital
Lusaka
Carolyn Chibundi, 260 (country) 977541659, carolyn.chibundi@cidrz.org
Taonga Musonda, MS, 260 (country) 971964760, taonga@tropgan.com
- Recruiting
University Teaching Hospital
Lusaka
Edford Sinkala, MBChB, PhD, 260 (country) 974 662 483, sinkalaeddie@yahoo.com
Taonga Musonda, MS, 260 (country) 971964760, taonga@tropgan.com
About this study
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.
- Conditions
- Hepatitis B, HIV
- Keywords
- HBV/HIV coinfection, HBV immunology, Liver sampling, Africa, Tenofovir, T cell immunology, Omics analysis, Acute HBV infection, Liver immunology
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Treatment-naive chronic HBV monoinfection and eligible for antiviral therapy | Adults who are HBsAg-positive, HIV-positive, eligible for HBV antiviral therapy and has not yet or just started taking therapy | |
| Treatment-naive acute HBV monoinfection | Adults who are HBsAg-positive, HIV-negative, and have the syndrome of acute hepatitis | |
| Treatment-naive HBV/HIV coinfection | Adults who are both HBsAg and HIV positive, and are not yet or just started taking HBV-active ART | |
| Treatment-experienced HBV/HIV coinfection with persistent HBsAg-emia | Adults with HBV/HIV coinfection and persistent HBsAg-emia after at least 4 years of HBV-active ART | |
| Treatment-experienced HBV infection with HBsAg loss | Adults with and without HIV coinfection who have a documented history of chronic HBV infection that subsequently resolved (i.e., HBsAg loss) during antiviral therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Intrahepatic Immune Cell Subset Frequencies
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.
Measured: Baseline and 1 year
Number of Differentially Expressed Hepatic Genes Associated with HBsAg Reduction/Loss
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.
Measured: Baseline and 1 year
Secondary outcomes (4)
HBV viral suppression
Reduction of HBV DNA in blood to below detectable levels
Measured: Baseline, 1 year, 2 years, 3 years, 4 years, and 5 years
HIV viral suppression
HIV RNA suppression in blood below the level of assay detection
Measured: Baseline, 1 year, 2 years, 3 years, 4 years, and 5 years
HBsAg seroclearance
Loss of hepatitis B surface antigen in blood samples
Measured: Through study completion, an average of 5 years
HBeAg seroconversion
HBeAg-negativity in blood
Measured: Through study completion, an average of 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start28 Sep 2020
- Primary completion31 Aug 2029 (estimated)
- Study completion31 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Hepatitis BStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 390 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Centre for Infectious Disease Research in Zambia, Tropical Gastroenterology and Nutrition Group, University of Zambia, Massachusetts General Hospital, Weill Medical College of Cornell University
- Responsible party
- Principal investigator, Michael Vinikoor, University of Alabama at Birmingham
- Investigators
- Michael Vinikoor, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07589985
- Sponsor's protocol ID
- IRB-300003590
- Other IDs
- R37AI179640, R01AI147727, R01AI195435, 316-2019
- Acronym
- Hep Mec
- Status last verified
- Jan 2026
- First submitted
- 5 Feb 2026
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All study results and anonymized participant data will be made publicly-available. The timing will be based on when analysis is completed and results are disseminated. The study also will adhere to Zambian laws around data protection and sharing.
Publications
Vinikoor MJ, Hamusonde K, Muula G, Asombang M, Riebensahm C, Chitundu H, Sunkuntu-Sichizya V, Bhattacharya D, Sinkala E, Lauer G, Chung R, Mbewe W, Egger M, Bosomprah S, Wandeler G. Long-term Hepatitis B and Liver Outcomes Among Adults Taking Tenofovir-Containing Antiretroviral Therapy for HBV/HIV Coinfection in Zambia. Clin Infect Dis. 2024 Jun 14;78(6):1583-1590. doi: 10.1093/cid/ciad654.
PubMed 37997691Chihota BV, Wandeler G, Chilengi R, Mulenga L, Chung RT, Bhattacharya D, Egger M, Vinikoor MJ. High Rates of Hepatitis B Virus (HBV) Functional Cure Among Human Immunodeficiency Virus-HBV Coinfected Patients on Antiretroviral Therapy in Zambia. J Infect Dis. 2020 Jan 2;221(2):218-222. doi: 10.1093/infdis/jiz450.
PubMed 31613956Muula GK, Bosomprah S, Sinkala E, Nsokolo B, Musonda T, Hamusonde K, Bhattacharya D, Lauer G, Chung RT, Mulenga LB, Wandeler G, Vinikoor MJ. Hepatitis B viral replication markers and hepatic fibrosis in untreated chronic hepatitis B virus infection with and without HIV coinfection in Zambia. AIDS. 2023 Nov 1;37(13):2015-2020. doi: 10.1097/QAD.0000000000003659. Epub 2023 Jul 17.
PubMed 37467044Vinikoor MJ, Walker A, Nsokolo B, Musonda T, Muula G, Michailidis E, Wandeler G, Alatrakchi N, Kelly P, Damagnez M, Le DB, Voges A, Lubke N, Kanunga A, Bosomprah S, Bhattacharya D, Chibundi C, Bwalya G, Musukuma-Chifulo K, Suslov A, Feuerherd M, Heim MH, Schwartz RE, Chung RT, Lauer G, Sinkala E, Timm J. Whole-Genome Sequencing of Hepatitis B Virus Genotypes E and A in Zambia Reveals Limited Viral Diversity in HIV Coinfection. Open Forum Infect Dis. 2025 Oct 1;12(11):ofaf616. doi: 10.1093/ofid/ofaf616. eCollection 2025 Nov.
PubMed 41200694Musonda T, Wallace MS, Patel H, Martin OP, Oetheimer C, Mwakamui S, Sinkala E, Nsokolo B, Kanunga A, Lauer G, Chung RT, Wandeler G, Bhattacharya D, Kelly P, Alatrakchi N, Vinikoor MJ. New Window Into Hepatitis B in Africa: Liver Sampling Combined With Single-Cell Omics Enables Deep and Longitudinal Assessment of Intrahepatic Immunity in Zambia. J Infect Dis. 2024 Nov 15;230(5):e1171-e1175. doi: 10.1093/infdis/jiae054.
PubMed 38332750
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hep Mec Cohort in Zambia
- ClinicalTrials.gov ID
- NCT07589985
- Acronym / sponsor ID
- Hep Mec / IRB-300003590
- Conditions
- Hepatitis B, HIV
- Keywords
- HBV/HIV coinfection, HBV immunology, Liver sampling, Africa, Tenofovir, T cell immunology, Omics analysis, Acute HBV infection
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 390 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Centre for Infectious Disease Research in Zambia, Tropical Gastroenterology and Nutrition Group, University of Zambia, Massachusetts General Hospital, Weill Medical College of Cornell University
- Study start
- 28 Sep 2020 (actual)
- Primary completion
- 31 Aug 2029 (estimated)
- Study completion
- 31 Aug 2030 (estimated)
- First posted
- 15 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Treatment-naive chronic HBV monoinfection and eligible for antiviral therapy | – | –Adults who are HBsAg-positive, HIV-positive, eligible for HBV antiviral therapy and has not yet or just started taking therapy |
| Treatment-naive acute HBV monoinfection | – | –Adults who are HBsAg-positive, HIV-negative, and have the syndrome of acute hepatitis |
| Treatment-naive HBV/HIV coinfection | – | –Adults who are both HBsAg and HIV positive, and are not yet or just started taking HBV-active ART |
| Treatment-experienced HBV/HIV coinfection with persistent HBsAg-emia | – | –Adults with HBV/HIV coinfection and persistent HBsAg-emia after at least 4 years of HBV-active ART |
| Treatment-experienced HBV infection with HBsAg loss | – | –Adults with and without HIV coinfection who have a documented history of chronic HBV infection that subsequently resolved (i.e., HBsAg loss) during antiviral therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
4 secondary outcomes
HBV viral suppression
Time frame: Baseline, 1 year, 2 years, 3 years, 4 years, and 5 years
HIV viral suppression
Time frame: Baseline, 1 year, 2 years, 3 years, 4 years, and 5 years
HBsAg seroclearance
Time frame: Through study completion, an average of 5 years
HBeAg seroconversion
Time frame: Through study completion, an average of 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Background: PubMed 37997691Vinikoor MJ, Hamusonde K, Muula G, Asombang M, Riebensahm C, Chitundu H, Sunkuntu-Sichizya V, Bhattacharya D, Sinkala E, Lauer G, Chung R, Mbewe W, Egger M, Bosomprah S, Wandeler G. Long-term Hepatitis B and Liver Outcomes Among Adults Taking Tenofovir-Containing Antiretroviral Therapy for HBV/HIV Coinfection in Zambia. Clin Infect Dis. 2024 Jun 14;78(6):1583-1590. doi: 10.1093/cid/ciad654.
- Background: PubMed 31613956Chihota BV, Wandeler G, Chilengi R, Mulenga L, Chung RT, Bhattacharya D, Egger M, Vinikoor MJ. High Rates of Hepatitis B Virus (HBV) Functional Cure Among Human Immunodeficiency Virus-HBV Coinfected Patients on Antiretroviral Therapy in Zambia. J Infect Dis. 2020 Jan 2;221(2):218-222. doi: 10.1093/infdis/jiz450.
- Background: PubMed 37467044Muula GK, Bosomprah S, Sinkala E, Nsokolo B, Musonda T, Hamusonde K, Bhattacharya D, Lauer G, Chung RT, Mulenga LB, Wandeler G, Vinikoor MJ. Hepatitis B viral replication markers and hepatic fibrosis in untreated chronic hepatitis B virus infection with and without HIV coinfection in Zambia. AIDS. 2023 Nov 1;37(13):2015-2020. doi: 10.1097/QAD.0000000000003659. Epub 2023 Jul 17.
- Results publication: PubMed 41200694Vinikoor MJ, Walker A, Nsokolo B, Musonda T, Muula G, Michailidis E, Wandeler G, Alatrakchi N, Kelly P, Damagnez M, Le DB, Voges A, Lubke N, Kanunga A, Bosomprah S, Bhattacharya D, Chibundi C, Bwalya G, Musukuma-Chifulo K, Suslov A, Feuerherd M, Heim MH, Schwartz RE, Chung RT, Lauer G, Sinkala E, Timm J. Whole-Genome Sequencing of Hepatitis B Virus Genotypes E and A in Zambia Reveals Limited Viral Diversity in HIV Coinfection. Open Forum Infect Dis. 2025 Oct 1;12(11):ofaf616. doi: 10.1093/ofid/ofaf616. eCollection 2025 Nov.
- Results publication: PubMed 38332750Musonda T, Wallace MS, Patel H, Martin OP, Oetheimer C, Mwakamui S, Sinkala E, Nsokolo B, Kanunga A, Lauer G, Chung RT, Wandeler G, Bhattacharya D, Kelly P, Alatrakchi N, Vinikoor MJ. New Window Into Hepatitis B in Africa: Liver Sampling Combined With Single-Cell Omics Enables Deep and Longitudinal Assessment of Intrahepatic Immunity in Zambia. J Infect Dis. 2024 Nov 15;230(5):e1171-e1175. doi: 10.1093/infdis/jiae054.
- Grant funding abstract on NIH websiteLink provided by the sponsor.
- Grant funding abstract on NIH websiteLink provided by the sponsor.
- Grant funding abstract on NIH websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All study results and anonymized participant data will be made publicly-available. The timing will be based on when analysis is completed and results are disseminated. The study also will adhere to Zambian laws around data protection and sharing.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael Vinikoor, MD principal investigator
University of Alabama at Birmingham
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis B and HIV, run by University of Alabama at Birmingham at 3 sites in Zambia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Zambia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael J Vinikoor, MD (205-934-5191, mjv3@uab.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Intrahepatic Immune Cell Subset Frequencies (time frame: Baseline and 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07589985, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.