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Antiretroviral Treatment Outcomes in HIV-HBV Co-infected Patients in Southern Africa | Clinical Trials | Clareo Health

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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)

NCT02060162•University of Alabama at Birmingham

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 99 years

Sex

ALL

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

Locations (1)

Centre for Infectious Disease Research in Zambia

Lusaka, Zambia

Key Dates

Start Date

October 1, 2013

Primary Completion Date

January 1, 2021

Completion Date

January 1, 2021

Last Updated

November 12, 2021

Enrollment

897

ACTUAL participants

Conditions

Hepatitis B VirusHIVAntiretroviral TherapyAfricaLiver FibrosisAlcohol Use Disorder

Interventions

Standard of care

OTHER

Therapy Adapted for High Risk and Low Risk HIV-Associated Anal Cancer

NCT04929028

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RECRUITINGPHASE3

A Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-010)

NCT07071623

Human Immunodeficiency Virus (HIV)HIV Pre-Exposure Prophylaxis

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 12, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Therapy Adapted for High Risk and Low Risk HIV-Associated Anal Cancer

A Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-010)

Thinking and Memory Problems in People With HIV

Long-acting Cabotegravir Injectable Pre-exposure Prophylaxis for People Who Inject Drugs

The LD Lync Study - Natural History Study of Lipodystrophy Syndromes

Imaging and Biopsy of People With HIV-1 Undergoing Analytic Treatment Interruption