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

N/ACompletedNCT02060162

University of Alabama at Birmingham897 enrolled

Overview

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.

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

897

Conditions

Hepatitis B Virus HIV Antiretroviral Therapy Africa Liver Fibrosis Alcohol Use Disorder

Interventions

Standard of careOTHER

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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

Locations (1)

Centre for Infectious Disease Research in Zambia

Lusaka, Zambia

Outcomes

Primary Outcomes

Immunological response

A linear mixed effect model will be used to evaluate immunological response to ART in patients with and without viral hepatitis

Time frame: 12 months post enrollment

Secondary Outcomes

HIV virological response

Virological response will be evaluated using Cox regression analyses.

Time frame: 12 months post enrollment

Mortality

Deaths will be ascertained

Time frame: 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.

Time frame: 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.

Time frame: 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

Time frame: 1 and 2 years post enrollment

Incidence of HBV infection

The incidence of HBV infection during ART will be measured.

Time frame: 12 and 24 months post enrollment

Prevalence of HIV/HCV coinfection

Data from ClinicalTrials.gov

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