| NCT ID | NCT07589985 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Alabama at Birmingham |
| Condition | Hepatitis B |
| Study Type | OBSERVATIONAL |
| Enrollment | 390 participants |
| Start Date | 2020-09-28 |
| Primary Completion | 2029-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 390 participants in total. It began in 2020-09-28 with a primary completion date of 2029-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: 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 Exclusion Criteria: * 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
Contact & Investigator
Michael Vinikoor, MD
PRINCIPAL INVESTIGATOR
University of Alabama at Birmingham
Frequently Asked Questions
Who can join the NCT07589985 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hepatitis B. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07589985 currently recruiting?
Yes, NCT07589985 is actively recruiting participants. Contact the research team at mjv3@uab.edu for enrollment information.
Where is the NCT07589985 trial being conducted?
This trial is being conducted at Lusaka, Zambia, Lusaka, Zambia, Lusaka, Zambia.
Who is sponsoring the NCT07589985 clinical trial?
NCT07589985 is sponsored by University of Alabama at Birmingham. The principal investigator is Michael Vinikoor, MD at University of Alabama at Birmingham. The trial plans to enroll 390 participants.