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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by University of North Carolina, Chapel Hill
Sponsor:
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: NA
Last verified: February 2014
History: No changes posted

February 9, 2014
February 9, 2014
December 2012
June 2015   (final data collection date for primary outcome measure)
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
Same as current
No Changes Posted
  • 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.
Same as current
Not Provided
Not Provided
 
Antiretroviral Treatment Outcomes in HIV-HBV Co-infected Patients in Southern Africa
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)

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.

The study will take place during routinely scheduled ART visits as per Ministry of Health. 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 three sites with a total enrollment across all sites of 3000 participants. However our site will only enroll 1000.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

The laboratory will store any 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.

Non-Probability Sample

Enrollment of 1,000 consecutive patients starting ART at each of the three sites is planned.

  • Hepatitis B Virus
  • HIV
Other: Standard of care
routine standard of care per Ministry of Health protocol including blood draws and examinations.
  • HIV/HBV infected
    800 to 920 our site (1100 to 1230 in total) patients without chronic HBV infection
    Intervention: Other: Standard of care
  • HIV infected, Non HBV infected
    50 to 80 participants at our site (100 to 170 patients across all sites) with chronic HBV infection
    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.
 
Recruiting
1000
December 2015
June 2015   (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
Both
18 Years and older
No
Contact: Michael Vinikoor, MD 260 966921285 michael.vinikoor@cidrz.org
Zambia
 
NCT02060162
12-2568
No
Carolyn Bolton Moore, MD, University of North Carolina, Chapel Hill
Carolyn Bolton Moore, MD
Not Provided
Principal Investigator: Carolyn Bolton-Moore, MD Centre for Infectious Disease Research in Zambia
University of North Carolina, Chapel Hill
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP