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Human Immunodeficiency VirusNCT02344680

Liver Fibrosis in Zambian HIV-HBV Co-infected Patients

An observational study of Human Immunodeficiency Virus and HBV, run by University of Alabama at Birmingham at 1 site in Zambia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Human Immunodeficiency Virus, HBV, Fibrosis, Liver
What is being tested?
Anti-HIV Agents
How many people
349 participants
Where
1 siteZambia
Study dates
Oct 2015to 28 May 2026
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

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: 400 adults with HIV-HBV coinfection

Who may be able to join

  • 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

Who cannot join

  • Unable or unwilling to provide informed consent
  • Planning to relocate out of Lusaka district

Trial locations and contacts

1 site in 1 country.

Zambia1 site

  • Centre for Infectious Disease Research in Zambia (CIDRZ)

    Lusaka, Lusaka Province, 34681

Other trials in Zambia

About this study

Official title: Liver Fibrosis in Zambian HIV-HBV Co-infected Patients: a Long-term Prospective Cohort Study

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.

Read the detailed description

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.

Being tested
Anti-HIV Agents
Medical subject headings
Acquired Immunodeficiency Syndrome, Liver Cirrhosis, Carcinoma, Hepatocellular, Hepatitis D, Hepatitis, Alcoholic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Anti-HIV AgentsDrug

    Also called Anti-retroviral therapy

Study groups in NCT02344680
Study groupRoleWhat they receive
Adults with HIV-HBV co-infectionAdults with HIV-HBV co-infection who are receiving antiretroviral therapy
Receives: Drug: Anti-HIV Agents

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From baseline to 10 years of follow-up

Secondary outcomes (3)

  1. Prevalence of Significant Liver Fibrosis (Metavir F2 or Greater)

    Proportion of participants with median liver stiffness based on transient elastography of >=7 kPa

    Measured: At enrollment

  2. Prevalence of Persistent HBV Viremia: Measure HBV DNA at Month 24

    Proportion of participants with measure of HBV DNA above detection at month 24

    Measured: Month 24

  3. Incidence of Hepatocellular Carcinoma

    Number of new cases of hepatocellular carcinoma during follow-up

    Measured: From baseline to 10 years of follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2015 (estimated)
  2. Study startOct 2015
  3. Primary completion28 May 2026
  4. Study completion28 May 2026

Resources

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
349 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02344680
Sponsor's protocol ID
IRB-150819001
Other IDs
K01TW009998
Status last verified
May 2026
First submitted
12 Jan 2015
Last updated
2 Jul 2026
Data monitoring committee
No

Publications

  • Weber R, Sabin CA, Friis-Moller N, Reiss P, El-Sadr WM, Kirk O, Dabis F, Law MG, Pradier C, De Wit S, Akerlund B, Calvo G, Monforte Ad, Rickenbach M, Ledergerber B, Phillips AN, Lundgren JD. Liver-related deaths in persons infected with the human immunodeficiency virus: the D:A:D study. Arch Intern Med. 2006 Aug 14-28;166(15):1632-41. doi: 10.1001/archinte.166.15.1632.

    PubMed 16908797

  • Central Statistical Office (CSO) MoH, Tropical Diseases Research Centre, University of Zambia, and Macro International Inc. Zambia Demographic and Health Survey 2007. Calverton, Maryland, USA: CSO and Macro International Inc., 2009.

  • Kapembwa KC, Goldman JD, Lakhi S, Banda Y, Bowa K, Vermund SH, Mulenga J, Chama D, Chi BH. HIV, Hepatitis B, and Hepatitis C in Zambia. J Glob Infect Dis. 2011 Jul;3(3):269-74. doi: 10.4103/0974-777X.83534.

    PubMed 21887060

  • Hamers RL, Zaaijer HL, Wallis CL, Siwale M, Ive P, Botes ME, Sigaloff KC, Hoepelman AI, Stevens WS, Rinke de Wit TF; PharmAccess African Studies to Evaluate Resistance (PASER). HIV-HBV coinfection in Southern Africa and the effect of lamivudine- versus tenofovir-containing cART on HBV outcomes. J Acquir Immune Defic Syndr. 2013 Oct 1;64(2):174-82. doi: 10.1097/QAI.0b013e3182a60f7d.

    PubMed 23892239

  • Martin-Carbonero L, Teixeira T, Poveda E, Plaza Z, Vispo E, Gonzalez-Lahoz J, Soriano V. Clinical and virological outcomes in HIV-infected patients with chronic hepatitis B on long-term nucleos(t)ide analogues. AIDS. 2011 Jan 2;25(1):73-9. doi: 10.1097/QAD.0b013e328340fde2.

    PubMed 21076274

  • Tuma P, Medrano J, Resino S, Vispo E, Madejon A, Sanchez-Piedra C, Rivas P, Labarga P, Martin-Carbonero L, Barreiro P, Soriano V. Incidence of liver cirrhosis in HIV-infected patients with chronic hepatitis B or C in the era of highly active antiretroviral therapy. Antivir Ther. 2010;15(6):881-6. doi: 10.3851/IMP1630.

    PubMed 20834100

  • Kirk GD, Bah E, Montesano R. Molecular epidemiology of human liver cancer: insights into etiology, pathogenesis and prevention from The Gambia, West Africa. Carcinogenesis. 2006 Oct;27(10):2070-82. doi: 10.1093/carcin/bgl060. Epub 2006 May 5.

    PubMed 16679307

  • Stabinski L, Reynolds SJ, Ocama P, Laeyendecker O, Ndyanabo A, Kiggundu V, Boaz I, Gray RH, Wawer M, Thio C, Thomas DL, Quinn TC, Kirk GD; Rakai Health Sciences Program. High prevalence of liver fibrosis associated with HIV infection: a study in rural Rakai, Uganda. Antivir Ther. 2011;16(3):405-11. doi: 10.3851/IMP1783.

    PubMed 21555823

  • Crane M, Iser D, Lewin SR. Human immunodeficiency virus infection and the liver. World J Hepatol. 2012 Mar 27;4(3):91-8. doi: 10.4254/wjh.v4.i3.91.

    PubMed 22489261

  • Puoti M, Manno D, Nasta P, Carosi G. Hepatitis B virus and HIV coinfection in low-income countries: unmet needs. Clin Infect Dis. 2008 Feb 1;46(3):367-9. doi: 10.1086/525532. No abstract available.

    PubMed 18171305

  • Hoffmann CJ, Charalambous S, Martin DJ, Innes C, Churchyard GJ, Chaisson RE, Grant AD, Fielding KL, Thio CL. Hepatitis B virus infection and response to antiretroviral therapy (ART) in a South African ART program. Clin Infect Dis. 2008 Dec 1;47(11):1479-85. doi: 10.1086/593104.

    PubMed 18937580

  • Hawkins C, Christian B, Ye J, Nagu T, Aris E, Chalamilla G, Spiegelman D, Mugusi F, Mehta S, Fawzi W. Prevalence of hepatitis B co-infection and response to antiretroviral therapy among HIV-infected patients in Tanzania. AIDS. 2013 Mar 27;27(6):919-927. doi: 10.1097/QAD.0b013e32835cb9c8.

    PubMed 23196935

  • Wandeler G, Gsponer T, Bihl F, Bernasconi E, Cavassini M, Kovari H, Schmid P, Battegay M, Calmy A, Egger M, Furrer H, Rauch A; Swiss HIV Cohort Study. Hepatitis B virus infection is associated with impaired immunological recovery during antiretroviral therapy in the Swiss HIV cohort study. J Infect Dis. 2013 Nov 1;208(9):1454-8. doi: 10.1093/infdis/jit351. Epub 2013 Jul 30.

    PubMed 23901088

  • Easterbrook P, Sands A, Harmanci H. Challenges and priorities in the management of HIV/HBV and HIV/HCV coinfection in resource-limited settings. Semin Liver Dis. 2012 May;32(2):147-57. doi: 10.1055/s-0032-1316476. Epub 2012 Jul 3.

    PubMed 22760654

  • Kelly P, Saloojee H, Chen JY, Chung RT. Noncommunicable diseases in HIV infection in low- and middle-income countries: gastrointestinal, hepatic, and nutritional aspects. J Acquir Immune Defic Syndr. 2014 Sep 1;67 Suppl 1(0 1):S79-86. doi: 10.1097/QAI.0000000000000260.

    PubMed 25117963

Questions about this trial

What is this clinical trial studying?

An observational study of Human Immunodeficiency Virus and HBV, run by University of Alabama at Birmingham at 1 site 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 4 inclusion and 2 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: finished, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Yes. Results are posted in the registry (first posted 2 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reduction in Liver Fibrosis Stage (time frame: From baseline to 10 years of follow-up). 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 NCT02344680, which also lists 36 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 2 Jul 2026.

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