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

Sponsor

University of Alabama at Birmingham (Other)

Overall Status

Completed

CT.gov ID

NCT02060162

Collaborator

Centre for Infectious Disease Research in Zambia (Other), University of Bern (Other)

897

Enrollment

Location

Duration (Months)

10.3

Patients Per Site Per Month

Study Details

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	Phase
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

Actual Enrollment :

897 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 :

Oct 1, 2013

Actual Primary Completion Date :

Jan 1, 2021

Actual Study Completion Date :

Jan 1, 2021

Arms and Interventions

Arm	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.

Arm

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

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

HIV virological response [12 months post enrollment]
Virological response will be evaluated using Cox regression analyses.
Mortality [12 months]
Deaths will be ascertained
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 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.
Prevalence of HIV/HCV coinfection [Baseline]
Describe prevalence of coinfection at ART initiation
Alcohol use patterns [Baseline, 12, and 24 months]
Describe the proportion with unhealthy levels of drinking before and after ART

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	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

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