An observational study in Hepatitis B and HIV, sponsored by University of Alabama at Birmingham. Recruiting at 3 sites in Zambia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-15.
Sponsored by University of Alabama at Birmingham · Observational
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.
1,045 studies on the registry are indexed under Hepatitis B; 139 are open to participants now.
This study's planned enrollment of 390 is close to the median of 365 across 251 observational studies indexed under Hepatitis B.
Browse Hepatitis B studies →University of Alabama at Birmingham is the lead sponsor of 1,421 studies on the registry; 277 are open to participants now.
Of its 164 completed or terminated interventional studies of FDA-regulated products, 130 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Must meet the inclusion criteria for one of 5 groups, as follows:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adults who are HBsAg-positive, HIV-positive, eligible for HBV antiviral therapy and has not yet or just started taking therapy
Adults who are HBsAg-positive, HIV-negative, and have the syndrome of acute hepatitis
Adults who are both HBsAg and HIV positive, and are not yet or just started taking HBV-active ART
Adults with HBV/HIV coinfection and persistent HBsAg-emia after at least 4 years of HBV-active ART
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
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.
Time frame: 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.
Time frame: Baseline and 1 year
HBV viral suppression
Reduction of HBV DNA in blood to below detectable levels
Time frame: 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
Time frame: Baseline, 1 year, 2 years, 3 years, 4 years, and 5 years
HBsAg seroclearance
Loss of hepatitis B surface antigen in blood samples
Time frame: Through study completion, an average of 5 years
HBeAg seroconversion
HBeAg-negativity in blood
Time frame: Through study completion, an average of 5 years
Plan to share: 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.
Supporting information: Study protocol, Informed consent form
Time frame: Supporting information will be made available at study completion. IPD will be made available after completion of primary outcome analyses. We expect primary outcomes analyses will be completed in 2027, 2028, and 2029.
Access criteria: During the study, only staff in Zambia and collaborating investigators will have access to IPD and supporting information. After the end of the study, this will be gradually made publicly available.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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