Hep Mec Cohort in Zambia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Alabama at Birmingham
About this trial
Observational cohort of adults with acute and chronic hepatitis B infection in Zambia, with and without HIV coinfection. Participants join the study at the time of diagnosis and before or at the time when they are starting antiviral treatments and then they are followed up over multiple years to assess changes to their liver and evolution of HBV (and HIV if applicable) infection. All treatments for HBV and HIV are standard per local Ministry of Health guidelines.
Eligibility criteria
Qualifiers
Group 1 (rx-naive chronic hbv mono): 18+ years old, HBsAg-positive, HIV-negative, eligible for tenofovir-based therapy, reports taking therapy no more than 7 days (could have previously taken if has stopped >1 year ago).
Group 2 (acute hbv mono): 18+ years old, HBsAg-positive, HIV-negative, acute/subacute onset of hepatitis signs and symptoms and ALT >10 times upper limit of normal
Group 3 (rx-naive hbv/hiv coinfection): 18+ years old, HBsAg-positive, HIV-negative, eligible for tenofovir-based therapy, reports taking therapy no more than 7 days (could have previously taken if has stopped >1 year ago).
Group 4 (rx-experienced coinfection with hbv persistence): 18+ years old, history of chronic HBV infection based on two tests 6 months apart, HIV-positive, at least 4 years of tenofovir-based antiviral therapy, currently HBsAg-positive
Disqualifiers
Hepatitis C coinfection (antibody-positive and RNA-positive), current or recent (past 6 weeks) pregnancy, decompensated cirrhosis on physical examination, unlikely to remain in Lusaka for study duration
Trial design
Treatments tested in this trial
- Not listed
Trial groups
390 Participants
are grouped into 5 trial groupsSponsors and collaborators
University of Alabama at Birmingham
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator
Centre for Infectious Disease Research in Zambia
Collaborator
Tropical Gastroenterology and Nutrition Group
Collaborator
University of Zambia
Collaborator
Massachusetts General Hospital
Collaborator
Weill Medical College of Cornell University
Collaborator
Source ClinicalTrials.gov