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Register:	ClinicalTrials.gov
Last refreshed on:	15 November 2021
Main ID:	NCT02060162
Date of registration:	09/02/2014
Prospective Registration:	No
Primary sponsor:	University of Alabama at Birmingham
Public title:	Antiretroviral Treatment Outcomes in HIV-HBV Co-infected Patients in Southern Africa
Scientific 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)
Date of first enrolment:	October 2013
Target sample size:	897
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02060162
Study type:	Observational
Study design:
Phase:

Countries of recruitment
Zambia

Contacts

Name:	Roma Chilengi, MD
Address:
Telephone:
Email:
Affiliation:	Centre for Infectious Disease Research in Zambia

Name:	Michael Vinikoor, MD
Address:
Telephone:
Email:
Affiliation:	Centre for Infectious Disease Research in Zambia

Key inclusion & exclusion criteria

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

Age minimum: 18 Years
Age maximum: 99 Years
Gender: All

Health Condition(s) or Problem(s) studied

Hepatitis B Virus

Liver Fibrosis

Alcohol Use Disorder

Antiretroviral Therapy

Africa

HIV

Intervention(s)

Other: Standard of care

Primary Outcome(s)

Immunological response [Time Frame: 12 months post enrollment]

Secondary Outcome(s)

Hepatotoxicity events [Time Frame: 6 and 12 months]

Mortality [Time Frame: 12 months]

Incidence of HBV infection [Time Frame: 12 and 24 months post enrollment]

HIV virological response [Time Frame: 12 months post enrollment]

Prevalence liver fibrosis [Time Frame: Baseline and one year after start of ART]

Alcohol use patterns [Time Frame: Baseline, 12, and 24 months]

Prevalence of HIV/HCV coinfection [Time Frame: Baseline]

HBV drug resistance [Time Frame: 1 and 2 years post enrollment]

Secondary ID(s)

F160229001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Centre for Infectious Disease Research in Zambia

University of Bern

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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