Hepatitis B VirusNCT02060162
Antiretroviral Treatment Outcomes in HIV-HBV Co-infected Patients in Southern Africa
An observational study of Hepatitis B Virus and HIV, run by University of Alabama at Birmingham at 1 site in Zambia.
Trial summary
This is a prospective HIV cohort that aims to establish causes of liver disease among HIV-infected individuals in Zambia, including viral hepatitis and alcohol. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Hepatitis B Virus, HIV, Antiretroviral Therapy
- How many people
- 897 participants
- Where
- 1 siteZambia
- Study dates
- Oct 2013to 1 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Enrollment of 1,900 consecutive patients starting ART (900 in Zambia and 1,000 in Mozambique) is planned.
Who may be able to join
- HIV-infected
- Male or female aged ≥18 years
- ART naïve
- ART eligible as defined by Zambian or WHO treatment guidelines
- Initiating an ART regimen including at least 3 drugs at one of the study sites.
- Willing to provide signed informed consent and be followed at the clinical site.
Who cannot join
- Patients who are not planning to remain in the catchment area from which they were recruited for the duration of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Antiretroviral Treatment Outcomes in HIV-HBV Co-infected Patients in Southern Africa: a Collaborative Multi-country Prospective Cohort Analysis for International Epidemiologic Databases to Evaluate AIDS- Southern Africa (HIV/HBV-coinfection in IeDEA-SA)
This is a prospective HIV cohort that aims to establish causes of liver disease among HIV-infected individuals in Zambia, including viral hepatitis and alcohol.
Read the detailed description
The study will take place during routinely scheduled ART visits as per Ministry of Health guidelines. Routinely collected programmatic data will be used to assess general HIV outcomes (CD4 response, loss to follow-up, death) as well as collecting study specific data (hepatitis testing, questionnaire regarding risk factors for hepatitis/liver disease, and non-invasive liver scan) to address other aims. The study will be implemented at two sites in Southern Africa (Zambia and Mozambique) with a total enrollment across all sites of 1,900 participants. The Zambia site will only enroll 900.
- Conditions
- Hepatitis B Virus, HIV, Antiretroviral Therapy, Africa, Liver Fibrosis, Alcohol Use Disorder
- Being tested
- Standard of care
- Keywords
- antiretroviral therapy, Hepatitis C virus
- Medical subject headings
- Hepatitis B, Liver Cirrhosis, Alcoholism, Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of careOther
routine standard of care per Ministry of Health protocol including blood draws and examinations.
| Study group | Role | What they receive |
|---|---|---|
| HIV/HBV co-infected | 150-200 patients in Zambia and 250-300 across all sites Receives: Other: Standard of care | |
| HIV mono-infected | 700-750 patients in Zambia and 1600-1700 across all sites Receives: Other: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunological response
A linear mixed effect model will be used to evaluate immunological response to ART in patients with and without viral hepatitis
Measured: 12 months post enrollment
Secondary outcomes (8)
HIV virological response
Virological response will be evaluated using Cox regression analyses.
Measured: 12 months post enrollment
Mortality
Deaths will be ascertained
Measured: 12 months
Hepatotoxicity events
These events will be defined as an increase in the level of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 time the upper limit within the first year of ART.
Measured: 6 and 12 months
Prevalence liver fibrosis
The prevalence of liver fibrosis will be measured to compare HIV/hepatitis coinfected versus HIV monoinfected patients using transient elastography.
Measured: Baseline and one year after start of ART
HBV drug resistance
The presence of HBV drug resistance in co-infected patients who fail treatment after 1 year will be measured
Measured: 1 and 2 years post enrollment
Incidence of HBV infection
The incidence of HBV infection during ART will be measured.
Measured: 12 and 24 months post enrollment
Prevalence of HIV/HCV coinfection
Describe prevalence of coinfection at ART initiation
Measured: Baseline
Alcohol use patterns
Describe the proportion with unhealthy levels of drinking before and after ART
Measured: Baseline, 12, and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2014 (estimated)
- Study startOct 2013
- Primary completion1 Jan 2021
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Hepatitis B VirusStudies 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
- 897 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Centre for Infectious Disease Research in Zambia, University of Bern
- Responsible party
- Principal investigator, Michael Vinikoor, University of Alabama at Birmingham
- Investigators
- Roma Chilengi, MD, Principal investigator, Centre for Infectious Disease Research in ZambiaMichael Vinikoor, MD, Principal investigator, Centre for Infectious Disease Research in Zambia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02060162
- Sponsor's protocol ID
- F160229001
- Status last verified
- Nov 2021
- First submitted
- 9 Feb 2014
- Last updated
- 12 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Barth RE, Huijgen Q, Taljaard J, Hoepelman AI. Hepatitis B/C and HIV in sub-Saharan Africa: an association between highly prevalent infectious diseases. A systematic review and meta-analysis. Int J Infect Dis. 2010 Dec;14(12):e1024-31. doi: 10.1016/j.ijid.2010.06.013. Epub 2010 Sep 25.
PubMed 20870439Chang TT, Gish RG, de Man R, Gadano A, Sollano J, Chao YC, Lok AS, Han KH, Goodman Z, Zhu J, Cross A, DeHertogh D, Wilber R, Colonno R, Apelian D; BEHoLD AI463022 Study Group. A comparison of entecavir and lamivudine for HBeAg-positive chronic hepatitis B. N Engl J Med. 2006 Mar 9;354(10):1001-10. doi: 10.1056/NEJMoa051285.
PubMed 16525137Davies J, van Oosterhout JJ, Nyirenda M, Bowden J, Moore E, Hart IJ, Zijlstra EE, Chaponda M, Faragher B, Beeching NJ, Beadsworth MB. Reliability of rapid testing for hepatitis B in a region of high HIV endemicity. Trans R Soc Trop Med Hyg. 2010 Feb;104(2):162-4. doi: 10.1016/j.trstmh.2009.10.010.
PubMed 19931107De Luca A, Bugarini R, Lepri AC, Puoti M, Girardi E, Antinori A, Poggio A, Pagano G, Tositti G, Cadeo G, Macor A, Toti M, D'Arminio Monforte A; Italian Cohort Naive Antiretrovirals Study Group. Coinfection with hepatitis viruses and outcome of initial antiretroviral regimens in previously naive HIV-infected subjects. Arch Intern Med. 2002 Oct 14;162(18):2125-32. doi: 10.1001/archinte.162.18.2125.
PubMed 12374521Di Bisceglie AM, Maskew M, Schulze D, Reyneke A, McNamara L, Firnhaber C. HIV-HBV coinfection among South African patients receiving antiretroviral therapy. Antivir Ther. 2010;15(3 Pt B):499-503. doi: 10.3851/IMP1494.
PubMed 20516571Dienstag JL, Schiff ER, Wright TL, Perrillo RP, Hann HW, Goodman Z, Crowther L, Condreay LD, Woessner M, Rubin M, Brown NA. Lamivudine as initial treatment for chronic hepatitis B in the United States. N Engl J Med. 1999 Oct 21;341(17):1256-63. doi: 10.1056/NEJM199910213411702.
PubMed 10528035Firnhaber C, Reyneke A, Schulze D, Malope B, Maskew M, MacPhail P, Sanne I, Di Bisceglie A. The prevalence of hepatitis B co-infection in a South African urban government HIV clinic. S Afr Med J. 2008 Jul;98(7):541-4.
PubMed 18785395Hoffmann 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 18937580Hoffmann CJ, Charalambous S, Thio CL, Martin DJ, Pemba L, Fielding KL, Churchyard GJ, Chaisson RE, Grant AD. Hepatotoxicity in an African antiretroviral therapy cohort: the effect of tuberculosis and hepatitis B. AIDS. 2007 Jun 19;21(10):1301-8. doi: 10.1097/QAD.0b013e32814e6b08.
PubMed 17545706KASOLO, F. (2003) Hepatitis B virus infection in human immunodeficiency virus seropositive patients at the University Teaching Hospital, Lusaka, Zambia: Interrelationship. IN SAKALA, I. (Ed.) Abstract no. B12601. The XV International Aids Conference, International Aids Society.
Kwon H, Lok AS. Hepatitis B therapy. Nat Rev Gastroenterol Hepatol. 2011 May;8(5):275-84. doi: 10.1038/nrgastro.2011.33. Epub 2011 Mar 22.
PubMed 21423260Lok AS, Lai CL, Leung N, Yao GB, Cui ZY, Schiff ER, Dienstag JL, Heathcote EJ, Little NR, Griffiths DA, Gardner SD, Castiglia M. Long-term safety of lamivudine treatment in patients with chronic hepatitis B. Gastroenterology. 2003 Dec;125(6):1714-22. doi: 10.1053/j.gastro.2003.09.033.
PubMed 14724824Lok AS, Zoulim F, Locarnini S, Bartholomeusz A, Ghany MG, Pawlotsky JM, Liaw YF, Mizokami M, Kuiken C; Hepatitis B Virus Drug Resistance Working Group. Antiviral drug-resistant HBV: standardization of nomenclature and assays and recommendations for management. Hepatology. 2007 Jul;46(1):254-65. doi: 10.1002/hep.21698.
PubMed 17596850Marcellin P, Heathcote EJ, Buti M, Gane E, de Man RA, Krastev Z, Germanidis G, Lee SS, Flisiak R, Kaita K, Manns M, Kotzev I, Tchernev K, Buggisch P, Weilert F, Kurdas OO, Shiffman ML, Trinh H, Washington MK, Sorbel J, Anderson J, Snow-Lampart A, Mondou E, Quinn J, Rousseau F. Tenofovir disoproxil fumarate versus adefovir dipivoxil for chronic hepatitis B. N Engl J Med. 2008 Dec 4;359(23):2442-55. doi: 10.1056/NEJMoa0802878.
PubMed 19052126Nagu TJ, Bakari M, Matee M. Hepatitis A, B and C viral co-infections among HIV-infected adults presenting for care and treatment at Muhimbili National Hospital in Dar es Salaam, Tanzania. BMC Public Health. 2008 Dec 19;8:416. doi: 10.1186/1471-2458-8-416.
PubMed 19099553
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antiretroviral Treatment Outcomes in HIV-HBV Co-infected Patients in Southern Africa: a Collaborative Multi-country Prospective Cohort Analysis for International Epidemiologic Databases to Evaluate AIDS- Southern Africa (HIV/HBV-coinfection in IeDEA-SA)
- ClinicalTrials.gov ID
- NCT02060162
- Acronym / sponsor ID
- F160229001
- Conditions
- Hepatitis B Virus, HIV, Antiretroviral Therapy, Africa, Liver Fibrosis, Alcohol Use Disorder
- Keywords
- antiretroviral therapy, Hepatitis C virus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 897 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Centre for Infectious Disease Research in Zambia, University of Bern
- Study start
- Oct 2013
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 11 Feb 2014 (estimated)
- 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.
This is a prospective HIV cohort that aims to establish causes of liver disease among HIV-infected individuals in Zambia, including viral hepatitis and alcohol.
Detailed description
The study will take place during routinely scheduled ART visits as per Ministry of Health guidelines. Routinely collected programmatic data will be used to assess general HIV outcomes (CD4 response, loss to follow-up, death) as well as collecting study specific data (hepatitis testing, questionnaire regarding risk factors for hepatitis/liver disease, and non-invasive liver scan) to address other aims. The study will be implemented at two sites in Southern Africa (Zambia and Mozambique) with a total enrollment across all sites of 1,900 participants. The Zambia site will only enroll 900.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIV/HBV co-infected | – | Other: Standard of care150-200 patients in Zambia and 250-300 across all sites |
| HIV mono-infected | – | Other: Standard of care700-750 patients in Zambia and 1600-1700 across all sites |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Enrollment of 1,900 consecutive patients starting ART (900 in Zambia and 1,000 in Mozambique) is planned.
Key inclusion criteria (6 listed)
- HIV-infected
- Male or female aged ≥18 years
- ART naïve
- ART eligible as defined by Zambian or WHO treatment guidelines
- Initiating an ART regimen including at least 3 drugs at one of the study sites.
Key exclusion criteria (1 listed)
- Patients who are not planning to remain in the catchment area from which they were recruited for the duration of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of careroutine standard of care per Ministry of Health protocol including blood draws and examinations. | Other | HIV mono-infected, HIV/HBV co-infected |
Primary outcome
Immunological response
Time frame: 12 months post enrollment
A linear mixed effect model will be used to evaluate immunological response to ART in patients with and without viral hepatitis
8 secondary outcomes
HIV virological response
Time frame: 12 months post enrollment
Mortality
Time frame: 12 months
Hepatotoxicity events
Time frame: 6 and 12 months
Prevalence liver fibrosis
Time frame: Baseline and one year after start of ART
HBV drug resistance
Time frame: 1 and 2 years post enrollment
Incidence of HBV infection
Time frame: 12 and 24 months post enrollment
Prevalence of HIV/HCV coinfection
Time frame: Baseline
Alcohol use patterns
Time frame: Baseline, 12, and 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2021.
- Background: PubMed 20870439Barth RE, Huijgen Q, Taljaard J, Hoepelman AI. Hepatitis B/C and HIV in sub-Saharan Africa: an association between highly prevalent infectious diseases. A systematic review and meta-analysis. Int J Infect Dis. 2010 Dec;14(12):e1024-31. doi: 10.1016/j.ijid.2010.06.013. Epub 2010 Sep 25.
- Background: PubMed 16525137Chang TT, Gish RG, de Man R, Gadano A, Sollano J, Chao YC, Lok AS, Han KH, Goodman Z, Zhu J, Cross A, DeHertogh D, Wilber R, Colonno R, Apelian D; BEHoLD AI463022 Study Group. A comparison of entecavir and lamivudine for HBeAg-positive chronic hepatitis B. N Engl J Med. 2006 Mar 9;354(10):1001-10. doi: 10.1056/NEJMoa051285.
- Background: PubMed 19931107Davies J, van Oosterhout JJ, Nyirenda M, Bowden J, Moore E, Hart IJ, Zijlstra EE, Chaponda M, Faragher B, Beeching NJ, Beadsworth MB. Reliability of rapid testing for hepatitis B in a region of high HIV endemicity. Trans R Soc Trop Med Hyg. 2010 Feb;104(2):162-4. doi: 10.1016/j.trstmh.2009.10.010.
- Background: PubMed 12374521De Luca A, Bugarini R, Lepri AC, Puoti M, Girardi E, Antinori A, Poggio A, Pagano G, Tositti G, Cadeo G, Macor A, Toti M, D'Arminio Monforte A; Italian Cohort Naive Antiretrovirals Study Group. Coinfection with hepatitis viruses and outcome of initial antiretroviral regimens in previously naive HIV-infected subjects. Arch Intern Med. 2002 Oct 14;162(18):2125-32. doi: 10.1001/archinte.162.18.2125.
- Background: PubMed 20516571Di Bisceglie AM, Maskew M, Schulze D, Reyneke A, McNamara L, Firnhaber C. HIV-HBV coinfection among South African patients receiving antiretroviral therapy. Antivir Ther. 2010;15(3 Pt B):499-503. doi: 10.3851/IMP1494.
- Background: PubMed 10528035Dienstag JL, Schiff ER, Wright TL, Perrillo RP, Hann HW, Goodman Z, Crowther L, Condreay LD, Woessner M, Rubin M, Brown NA. Lamivudine as initial treatment for chronic hepatitis B in the United States. N Engl J Med. 1999 Oct 21;341(17):1256-63. doi: 10.1056/NEJM199910213411702.
- Background: PubMed 18785395Firnhaber C, Reyneke A, Schulze D, Malope B, Maskew M, MacPhail P, Sanne I, Di Bisceglie A. The prevalence of hepatitis B co-infection in a South African urban government HIV clinic. S Afr Med J. 2008 Jul;98(7):541-4.
- Background: PubMed 18937580Hoffmann 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.
- Background: PubMed 17545706Hoffmann CJ, Charalambous S, Thio CL, Martin DJ, Pemba L, Fielding KL, Churchyard GJ, Chaisson RE, Grant AD. Hepatotoxicity in an African antiretroviral therapy cohort: the effect of tuberculosis and hepatitis B. AIDS. 2007 Jun 19;21(10):1301-8. doi: 10.1097/QAD.0b013e32814e6b08.
- BackgroundKASOLO, F. (2003) Hepatitis B virus infection in human immunodeficiency virus seropositive patients at the University Teaching Hospital, Lusaka, Zambia: Interrelationship. IN SAKALA, I. (Ed.) Abstract no. B12601. The XV International Aids Conference, International Aids Society.
- Background: PubMed 21423260Kwon H, Lok AS. Hepatitis B therapy. Nat Rev Gastroenterol Hepatol. 2011 May;8(5):275-84. doi: 10.1038/nrgastro.2011.33. Epub 2011 Mar 22.
- Background: PubMed 14724824Lok AS, Lai CL, Leung N, Yao GB, Cui ZY, Schiff ER, Dienstag JL, Heathcote EJ, Little NR, Griffiths DA, Gardner SD, Castiglia M. Long-term safety of lamivudine treatment in patients with chronic hepatitis B. Gastroenterology. 2003 Dec;125(6):1714-22. doi: 10.1053/j.gastro.2003.09.033.
- University of North Carolina websiteLink provided by the sponsor.
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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. This study is not recruiting at the moment.
Roma Chilengi, MD principal investigator
Centre for Infectious Disease Research in Zambia
Michael Vinikoor, MD principal investigator
Centre for Infectious Disease Research in Zambia
1 site 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 Virus and HIV, 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 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: finished, as of the sponsor's last update on 12 Nov 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Immunological response (time frame: 12 months post enrollment). 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 NCT02060162, which also lists 23 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 12 Nov 2021.