NCT02060162

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

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)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 897 (actual)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
OTHER	Standard of care	routine standard of care per Ministry of Health protocol including blood draws and examinations.

Timeline

• Start date: 2013-10-01
• Primary completion: 2021-01-01
• Completion: 2021-01-01
• First posted: 2014-02-11
• Last updated: 2021-11-12

Locations

1 site across 1 country: Zambia