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Antiretroviral Treatment Outcomes in HIV-HBV Co-infected Patients in Southern Africa

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02060162
Recruitment Status : Active, not recruiting
First Posted : February 11, 2014
Last Update Posted : May 24, 2017
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment
Hepatitis B Virus HIV Antiretroviral Therapy Africa Liver Fibrosis Alcohol Use Disorder Other: Standard of care

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

Study Type : Observational
Estimated Enrollment : 900 participants
Observational Model: Cohort
Time Perspective: Prospective
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)
Study Start Date : October 2013
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS Hepatitis
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
HIV/HBV co-infected
150-200 patients in Zambia and 250-300 across all sites
Other: Standard of care
routine standard of care per Ministry of Health protocol including blood draws and examinations.
HIV mono-infected
700-750 patients in Zambia and 1600-1700 across all sites
Other: Standard of care
routine standard of care per Ministry of Health protocol including blood draws and examinations.

Outcome Measures

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. HIV virological response [ Time Frame: 12 months post enrollment ]
    Virological response will be evaluated using Cox regression analyses.

  2. Mortality [ Time Frame: 12 months ]
    Deaths will be ascertained

  3. Hepatotoxicity events [ Time Frame: 6 and 12 months ]
    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.

  4. Prevalence liver fibrosis [ Time Frame: Baseline and one year after start of ART ]
    The prevalence of liver fibrosis will be measured to compare HIV/hepatitis coinfected versus HIV monoinfected patients using transient elastography.

  5. HBV drug resistance [ Time Frame: 1 and 2 years post enrollment ]
    The presence of HBV drug resistance in co-infected patients who fail treatment after 1 year will be measured

  6. Incidence of HBV infection [ Time Frame: 12 and 24 months post enrollment ]
    The incidence of HBV infection during ART will be measured.

  7. Prevalence of HIV/HCV coinfection [ Time Frame: Baseline ]
    Describe prevalence of coinfection at ART initiation

  8. Alcohol use patterns [ Time Frame: Baseline, 12, and 24 months ]
    Describe the proportion with unhealthy levels of drinking before and after ART

Biospecimen Retention:   Samples With DNA
Specimen storage is optional and participants will provide additional informed consent. The laboratory will store leftover blood specimens for up to 5 years for hepatitis related serologic, immunological, and virologic studies pending availability of funding. Use of specimens for any tests outside the realm of the goals and objectives of this study will require additional approval by the Zambian IRB.

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Enrollment of 1,900 consecutive patients starting ART (900 in Zambia and 1,000 in Mozambique) is planned.

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Patients who are not planning to remain in the catchment area from which they were recruited for the duration of the study
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02060162

Centre for Infectious Disease Research in Zambia
Lusaka, Zambia
Sponsors and Collaborators
University of Alabama at Birmingham
Centre for Infectious Disease Research in Zambia
University of Bern
Principal Investigator: Roma Chilengi, MD Centre for Infectious Disease Research in Zambia
Principal Investigator: Michael Vinikoor, MD Centre for Infectious Disease Research in Zambia
More Information

Additional Information:
KASOLO, 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.

Responsible Party: Michael Vinikoor, Assistant Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT02060162     History of Changes
Other Study ID Numbers: F160229001
First Posted: February 11, 2014    Key Record Dates
Last Update Posted: May 24, 2017
Last Verified: May 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Michael Vinikoor, University of Alabama at Birmingham:
antiretroviral therapy
Hepatitis C virus

Additional relevant MeSH terms:
Hepatitis B
Liver Cirrhosis
Liver Diseases
Digestive System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human