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Completed

NCT Number: NCT02060162

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

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.

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Key information

Conditions

Hepatitis B Virus Africa Alcohol Use Disorder Alcohol-Related Disorders Alcoholism Antiretroviral Therapy Blood-Borne Infections Chemically-Induced Disorders Communicable Diseases DNA Virus Infections Digestive System Diseases Fibrosis Flaviviridae Infections HIV Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis C Hepatitis, Viral, Human Infections Liver Cirrhosis Liver Diseases Liver Fibrosis Mental Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Substance-Related Disorders Virus Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre for Infectious Disease Research in Zambia

Lusaka, Zambia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard of care

Other

routine standard of care per Ministry of Health protocol including blood draws and examinations.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • Centre for Infectious Disease Research in Zambia
  • University of Bern

Registry information

Official study 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)

Important dates

Study start
2013
Primary completion
2021
Study completion
2021
First posted
Feb 11, 2014
Registry last updated
Nov 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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