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

Completed

• Conditions: Antiretroviral Therapy; Alcohol Use Disorder; Hepatitis B Virus; HIV; Africa; Liver Fibrosis
• Interventions: Other: Standard of care

• Registration Number: NCT02060162
• Lead Sponsor: University of Alabama at Birmingham

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.

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2014-02-09
• Study First Submitted QC: 2014-02-09
• Study First Posted: 2014-02-11
• Primary Completion: 2021-01-01
• Study Completion: 2021-01-01
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-05
• Last Update Posted: 2021-11-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 897

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.

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HIV/HBV co-infected	Standard of care	150-200 patients in Zambia and 250-300 across all sites
HIV mono-infected	Standard of care	700-750 patients in Zambia and 1600-1700 across all sites

Primary Outcome Measures

Name	Time	Method
Immunological response	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

Name	Time	Method
Mortality	12 months	Deaths will be ascertained
Prevalence liver fibrosis	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.
HBV drug resistance	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
Incidence of HBV infection	12 and 24 months post enrollment	The incidence of HBV infection during ART will be measured.
Alcohol use patterns	Baseline, 12, and 24 months	Describe the proportion with unhealthy levels of drinking before and after ART
HIV virological response	12 months post enrollment	Virological response will be evaluated using Cox regression analyses.
Hepatotoxicity events	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.
Prevalence of HIV/HCV coinfection	Baseline	Describe prevalence of coinfection at ART initiation

Trial Locations

Locations (1)

Centre for Infectious Disease Research in Zambia; 🇿🇲 Lusaka, Zambia