An observational study in Human Immunodeficiency Virus, HBV and Fibrosis, Liver, sponsored by University of Alabama at Birmingham. Completed at 1 site in Zambia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-02.
Sponsored by University of Alabama at Birmingham · Observational
A cohort of adults with HIV-HBV co-infection will be created in Lusaka, Zambia, to describe the short and long-term (up to 10 years of follow-up) HBV and liver outcomes, including the effectiveness of current therapies, and to identify the risk factors for major endpoints of interest, including HCC and HBV functional cure. This cohort will also create a pool of potential participants for in-depth mechanistic studies and clinical trials of novel HBV cure drugs.
Among people with HIV in Africa, liver disease is a neglected area of investigation but is anticipated to become increasingly common as patients live longer due to antiretroviral therapy. In Lusaka, Zambia, we previously (NCT02060162, clinicaltrials.gov) described that HIV-HBV co-infection was the most important liver risk factor. However, in that study, only very short-term outcomes could be assessed. Building on these preliminary results and addressing the need to study HIV-HBV during a longer duration of follow-up, the current protocol will focus exclusively on people with HIV-HBV in Zambia. Zambia is an ideal site for this research as it has \~12% HIV prevalence and 6% HBsAg-positivity among adults nationwide. In fact, \~70% of people with HIV-HBV globally reside in Africa. In the proposed study, we will obtain consent from people with HIV-HBV to participate in an observational cohort study with up to 10 years of follow-up. Standard of care antiviral therapies will be received by participants. More in-depth analysis of liver and HBV viral and serological outcomes will occur. Screening for liver cancer will also occur. This study will provide useful clinical and epidemiological information to health policymakers in Zambia and beyond. It will also provide a platform for the training of health workers in Zambia in HBV clinical management.
1,298 studies on the registry are indexed under Liver Cirrhosis; 338 are open to participants now.
This study's enrollment of 349 is above the median of 171 across 526 observational studies indexed under Liver Cirrhosis.
Browse Liver Cirrhosis 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.
Compared within Liver Cirrhosis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Acquired Immunodeficiency Syndrome. The counts are of registry records indexed under each term, refreshed daily. How we classify →
400 adults with HIV-HBV coinfection
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.
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.
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.
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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.
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.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adults with HIV-HBV co-infection who are receiving antiretroviral therapy
Drug: Anti-HIV Agents
Also known as: Anti-retroviral therapy
Reduction in Liver Fibrosis Stage
Based on transient elastography, we calculated the number and proportion of participants with at least significant fibrosis at their first measure who regressed to minimal-no fibrosis during follow-up. This outcome excluded participants with no-minimal fibrosis at enrollment.
Time frame: From baseline to 10 years of follow-up
Prevalence of Significant Liver Fibrosis (Metavir F2 or Greater)
Proportion of participants with median liver stiffness based on transient elastography of \>=7 kPa
Time frame: At enrollment
Prevalence of Persistent HBV Viremia: Measure HBV DNA at Month 24
Proportion of participants with measure of HBV DNA above detection at month 24
Time frame: Month 24
Incidence of Hepatocellular Carcinoma
Number of new cases of hepatocellular carcinoma during follow-up
Time frame: From baseline to 10 years of follow-up
Adults who were newly entering HIV care were screened for study eligibility and if they met all criteria and gave informed consent, they enrolled.
| Milestone | HBV/HIV Cohort |
|---|---|
| Started | 349 |
| Completed | 218 |
| Not completed | 131 |
| Withdrew: Lost to follow-up | 25 |
| Withdrew: Death | 47 |
| Withdrew: Withdrawal by subject | 18 |
| Withdrew: Transfer out | 41 |
Based on transient elastography, we calculated the number and proportion of participants with at least significant fibrosis at their first measure who regressed to minimal-no fibrosis during follow-up. This outcome excluded participants with no-minimal fibrosis at enrollment.
| Participants | HBV/HIV Cohort |
|---|---|
| Reduction in Liver Fibrosis Stage | 46 |
Proportion of participants with median liver stiffness based on transient elastography of \>=7 kPa
| Participants | HBV/HIV Cohort |
|---|---|
| Prevalence of Significant Liver Fibrosis (Metavir F2 or Greater) | 78 |
Proportion of participants with measure of HBV DNA above detection at month 24
| Participants | HBV/HIV Cohort |
|---|---|
| Prevalence of Persistent HBV Viremia: Measure HBV DNA at Month 24 | 34 |
Number of new cases of hepatocellular carcinoma during follow-up
| Participants | HBV/HIV Cohort |
|---|---|
| Incidence of Hepatocellular Carcinoma | 0 |
Collected over From enrollment to up to 10 years of follow-up. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| HBV/HIV Cohort | 47/349 (13.5%) | 47/349 (13.5%) | — |
| Event | HBV/HIV Cohort |
|---|---|
| All-cause mortalityGeneral disorders | 47/349 |
| Age, Categorical(Participants) | HBV/HIV Cohort |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 349 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | HBV/HIV Cohort |
|---|---|
| Female | 139 |
| Male | 210 |
| Race (NIH/OMB)(Participants) | HBV/HIV Cohort |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 349 |
| White | 0 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | HBV/HIV Cohort |
|---|---|
| Zambia | 349 |
| Baseline CD4 T cell count <200 cells/mm3(Participants) | HBV/HIV Cohort |
|---|---|
| Count of participants | 149 |
| Baseline HBV DNA >2000 IU/ml(Participants) | HBV/HIV Cohort |
|---|---|
| Count of participants | 158 |
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This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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University of Alabama at Birmingham →