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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02060162
First Posted: February 11, 2014
Last Update Posted: May 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Centre for Infectious Disease Research in Zambia
University of Bern
Information provided by (Responsible Party):
Michael Vinikoor, University of Alabama at Birmingham
February 9, 2014
February 11, 2014
May 24, 2017
October 2013
June 2021   (Final data collection date for primary outcome measure)
Immunological response [ Time Frame: 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
Immunological response [ Time Frame: 12 months post enrollment ]
a linear mixed effect model will be used to evaluate immunological response
Complete list of historical versions of study NCT02060162 on ClinicalTrials.gov Archive Site
  • HIV virological response [ Time Frame: 12 months post enrollment ]
    Virological response will be evaluated using Cox regression analyses.
  • Mortality [ Time Frame: 12 months ]
    Deaths will be ascertained
  • Hepatotoxicity events [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 12 and 24 months post enrollment ]
    The incidence of HBV infection during ART will be measured.
  • Prevalence of HIV/HCV coinfection [ Time Frame: Baseline ]
    Describe prevalence of coinfection at ART initiation
  • Alcohol use patterns [ Time Frame: Baseline, 12, and 24 months ]
    Describe the proportion with unhealthy levels of drinking before and after ART
  • Virological response [ Time Frame: 12 months post enrollment ]
    Virological response will be evaluated using Cox regression analyses.
  • Mortality [ Time Frame: 12 months ]
  • Hepatotoxicity events [ Time Frame: 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.
  • Incidence of liver fibrosis [ Time Frame: 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 [ Time Frame: 1 year 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 [ Time Frame: 6 and 12 months post enrollment ]
    The incidence of HBV infection during the first year of ART will be measured.
  • Prevalence of HIV/HCV coinfection [ Time Frame: 6 and 12 months post enrollment ]
  • Predictors of hepatitis coinfection and liver fibrosis [ Time Frame: enrollment, 6 and 12 months post ]
    Predictors such as heavy alcohol use, drug use, and sexual behaviors will be measured.
Not Provided
Not Provided
 
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)
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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
Specimen storage is optional and participants will provide additional informed consent. The laboratory will store leftover blood specimens for up to 5 years for hepatitis related serologic, immunological, and virologic studies pending availability of funding. Use of specimens for any tests outside the realm of the goals and objectives of this study will require additional approval by the Zambian IRB.
Non-Probability Sample
Enrollment of 1,900 consecutive patients starting ART (900 in Zambia and 1,000 in Mozambique) is planned.
  • Hepatitis B Virus
  • HIV
  • Antiretroviral Therapy
  • Africa
  • Liver Fibrosis
  • Alcohol Use Disorder
Other: Standard of care
routine standard of care per Ministry of Health protocol including blood draws and examinations.
  • HIV/HBV co-infected
    150-200 patients in Zambia and 250-300 across all sites
    Intervention: Other: Standard of care
  • HIV mono-infected
    700-750 patients in Zambia and 1600-1700 across all sites
    Intervention: Other: Standard of care

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
900
June 2021
June 2021   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 99 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Zambia
 
 
NCT02060162
F160229001
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Michael Vinikoor, University of Alabama at Birmingham
University of Alabama at Birmingham
  • Centre for Infectious Disease Research in Zambia
  • University of Bern
Principal Investigator: Roma Chilengi, MD Centre for Infectious Disease Research in Zambia
Principal Investigator: Michael Vinikoor, MD Centre for Infectious Disease Research in Zambia
University of Alabama at Birmingham
May 2017