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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2015 by University of North Carolina, Chapel Hill
Sponsor:
Collaborator:
Centre for Infectious Disease Research in Zambia
Information provided by (Responsible Party):
Carolyn Bolton Moore, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT02060162
First received: February 9, 2014
Last updated: February 8, 2015
Last verified: February 2015
  Purpose

This study aims to establish a cohort of patients starting antiretroviral therapy (ART) with chronic hepatitis B virus (HBV) infection and study the effect of chronic HBV on HIV- and liver-related outcomes according to ART regimen and site.


Condition Intervention
Hepatitis B Virus
HIV
Antiretroviral Therapy
Africa
Liver Fibrosis
Other: Standard of care

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: CIDRZ 1220 - 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)

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Immunological response [ Time Frame: 12 months post enrollment ] [ Designated as safety issue: No ]
    a linear mixed effect model will be used to evaluate immunological response


Secondary Outcome Measures:
  • Virological response [ Time Frame: 12 months post enrollment ] [ Designated as safety issue: No ]
    Virological response will be evaluated using Cox regression analyses.

  • Mortality [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Hepatotoxicity events [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Predictors of hepatitis coinfection and liver fibrosis [ Time Frame: enrollment, 6 and 12 months post ] [ Designated as safety issue: No ]
    Predictors such as heavy alcohol use, drug use, and sexual behaviors will be measured.


Biospecimen Retention:   Samples With DNA

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 REC.


Estimated Enrollment: 900
Study Start Date: December 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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 with a total enrollment across all sites of 1,900 participants. The Zambia site will only enroll 900.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Enrollment of 1,900 consecutive patients starting ART (900 in Zambia and 1,000 in Mozambique) is planned.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02060162

Contacts
Contact: Michael Vinikoor, MD 260 966921285 michael.vinikoor@cidrz.org

Locations
Zambia
Centre for Infectious Disease Research in Zambia Recruiting
Lusaka, Zambia
Contact: Michael Vinikoor, MD    260 966921285    michael.vinikoor@cidrz.org   
Principal Investigator: Caroloyn Bolton-Moore, MD         
Sponsors and Collaborators
Carolyn Bolton Moore, MD
Centre for Infectious Disease Research in Zambia
Investigators
Principal Investigator: Carolyn Bolton-Moore, MD Centre for Infectious Disease Research in Zambia
  More Information

Additional Information:
Publications:
KASOLO, F. (2003) Hepatitis B virus infection in human immunodeficiency virus seropositive patients at the University Teaching Hospital, Lusaka, Zambia: Interrelationship. IN SAKALA, I. (Ed.) Abstract no. B12601. The XV International Aids Conference, International Aids Society.

Responsible Party: Carolyn Bolton Moore, MD, Chief Medical Officer, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02060162     History of Changes
Other Study ID Numbers: CIDRZ 1220/IRB 12-2568
Study First Received: February 9, 2014
Last Updated: February 8, 2015
Health Authority: Zambia: Ministry of Health
Zambia: University of Zambia Biomedical Research Ethics Committee

Keywords provided by University of North Carolina, Chapel Hill:
antiretroviral therapy
Hepatitis C virus

ClinicalTrials.gov processed this record on August 03, 2015