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

November 5, 2021 updated by: Michael Vinikoor, University of Alabama at Birmingham

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

897

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Zambia
- - Lusaka, Zambia
    - Centre for Infectious Disease Research in Zambia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	12 months post enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HIV virological response Time Frame: 12 months post enrollment	Virological response will be evaluated using Cox regression analyses.	12 months post enrollment
Mortality Time Frame: 12 months	Deaths will be ascertained	12 months
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.	6 and 12 months
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.	Baseline and one year after start of ART
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	1 and 2 years post enrollment
Incidence of HBV infection Time Frame: 12 and 24 months post enrollment	The incidence of HBV infection during ART will be measured.	12 and 24 months post enrollment
Prevalence of HIV/HCV coinfection Time Frame: Baseline	Describe prevalence of coinfection at ART initiation	Baseline
Alcohol use patterns Time Frame: Baseline, 12, and 24 months	Describe the proportion with unhealthy levels of drinking before and after ART	Baseline, 12, and 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Collaborators

University of Bern

Centre for Infectious Disease Research in Zambia

Investigators

Principal Investigator: Roma Chilengi, MD, Centre for Infectious Disease Research in Zambia
Principal Investigator: Michael Vinikoor, MD, Centre for Infectious Disease Research in Zambia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

University of North Carolina website

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

January 1, 2021

Study Completion (Actual)

January 1, 2021

Study Registration Dates

First Submitted

February 9, 2014

First Submitted That Met QC Criteria

February 9, 2014

First Posted (Estimate)

February 11, 2014

Study Record Updates

Last Update Posted (Actual)

November 12, 2021

Last Update Submitted That Met QC Criteria

November 5, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

F160229001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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