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Hep Mec Cohort in Zambia

Status: Recruiting
Location: See all (3) locations...
Study Type: Observational
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ Must meet the inclusion criteria for one of 5 groups, as follows:

• 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

• Group 5 (hbsag loss): 18+ years old, HIV-positive or negative, history of chronic HBV infection based on two tests 6 months apart, Currently HBsAg-negative confirmed by sensitive assay

Locations
Other Locations
Zambia
Kanyama Level 1 Hospital
RECRUITING
Lusaka
Matero Level 1 Hospital
RECRUITING
Lusaka
University Teaching Hospital
RECRUITING
Lusaka
Contact Information
Primary
Michael J Vinikoor, MD
mjv3@uab.edu
205-934-5191
Backup
Ike Oyewole
ikeoluwaoyewole@uabmc.edu
205-996-0441
Time Frame
Start Date: 2020-09-28
Estimated Completion Date: 2030-08-31
Participants
Target number of participants: 390
Treatments
Treatment-naive chronic HBV monoinfection and eligible for antiviral therapy
Adults who are HBsAg-positive, HIV-positive, eligible for HBV antiviral therapy and has not yet or just started taking therapy
Treatment-naive acute HBV monoinfection
Adults who are HBsAg-positive, HIV-negative, and have the syndrome of acute hepatitis
Treatment-naive HBV/HIV coinfection
Adults who are both HBsAg and HIV positive, and are not yet or just started taking HBV-active ART
Treatment-experienced HBV/HIV coinfection with persistent HBsAg-emia
Adults with HBV/HIV coinfection and persistent HBsAg-emia after at least 4 years of HBV-active ART
Treatment-experienced HBV infection with HBsAg loss
Adults with and without HIV coinfection who have a documented history of chronic HBV infection that subsequently resolved (i.e., HBsAg loss) during antiviral therapy
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID), Weill Medical College of Cornell University, Tropical Gastroenterology and Nutrition Group, Massachusetts General Hospital, Centre for Infectious Disease Research in Zambia, University of Zambia
Leads: University of Alabama at Birmingham

This content was sourced from clinicaltrials.gov