Menu
Recruiting NCT07589985

Hep Mec Cohort in Zambia

— Observational Hepatitis B HIV

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Hepatitis B, HIV. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Zambia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Primary outcome measures

  • Change in Intrahepatic Immune Cell Subset Frequencies [Time frame: Baseline and 1 year]
  • Number of Differentially Expressed Hepatic Genes Associated with HBsAg Reduction/Loss [Time frame: Baseline and 1 year]
Secondary outcome measures (4)
  • HBV viral suppression [Time frame: Baseline, 1 year, 2 years, 3 years, 4 years, and 5 years]
  • HIV viral suppression [Time frame: Baseline, 1 year, 2 years, 3 years, 4 years, and 5 years]
  • HBsAg seroclearance [Time frame: Through study completion, an average of 5 years]
  • HBeAg seroconversion [Time frame: Through study completion, an average of 5 years]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Zambia · 3 centers
  • Kanyama Level 1 Hospital — Lusaka
  • Matero Level 1 Hospital — Lusaka
  • University Teaching Hospital — Lusaka

Publications

  • Vinikoor MJ, Hamusonde K, Muula G, Asombang M, Riebensahm C, Chitundu H, Sunkuntu-Sichizya V, Bhattacharya D, Sinkala E, Lauer G, Chung R, Mbewe W, Egger M, Bosomprah S, Wandeler G. Long-term Hepatitis B and Liver Outcomes Among Adults Taking Tenofovir-Containing Antiretroviral Therapy for HBV/HIV Coinfection in Zambia. Clin Infect Dis. 2024 Jun 14;78(6):1583-1590. doi: 10.1093/cid/ciad654. PMID 37997691
  • Chihota BV, Wandeler G, Chilengi R, Mulenga L, Chung RT, Bhattacharya D, Egger M, Vinikoor MJ. High Rates of Hepatitis B Virus (HBV) Functional Cure Among Human Immunodeficiency Virus-HBV Coinfected Patients on Antiretroviral Therapy in Zambia. J Infect Dis. 2020 Jan 2;221(2):218-222. doi: 10.1093/infdis/jiz450. PMID 31613956
  • Muula GK, Bosomprah S, Sinkala E, Nsokolo B, Musonda T, Hamusonde K, Bhattacharya D, Lauer G, Chung RT, Mulenga LB, Wandeler G, Vinikoor MJ. Hepatitis B viral replication markers and hepatic fibrosis in untreated chronic hepatitis B virus infection with and without HIV coinfection in Zambia. AIDS. 2023 Nov 1;37(13):2015-2020. doi: 10.1097/QAD.0000000000003659. Epub 2023 Jul 17. PMID 37467044
  • Vinikoor MJ, Walker A, Nsokolo B, Musonda T, Muula G, Michailidis E, Wandeler G, Alatrakchi N, Kelly P, Damagnez M, Le DB, Voges A, Lubke N, Kanunga A, Bosomprah S, Bhattacharya D, Chibundi C, Bwalya G, Musukuma-Chifulo K, Suslov A, Feuerherd M, Heim MH, Schwartz RE, Chung RT, Lauer G, Sinkala E, Timm J. Whole-Genome Sequencing of Hepatitis B Virus Genotypes E and A in Zambia Reveals Limited Viral PMID 41200694
  • Musonda T, Wallace MS, Patel H, Martin OP, Oetheimer C, Mwakamui S, Sinkala E, Nsokolo B, Kanunga A, Lauer G, Chung RT, Wandeler G, Bhattacharya D, Kelly P, Alatrakchi N, Vinikoor MJ. New Window Into Hepatitis B in Africa: Liver Sampling Combined With Single-Cell Omics Enables Deep and Longitudinal Assessment of Intrahepatic Immunity in Zambia. J Infect Dis. 2024 Nov 15;230(5):e1171-e1175. doi: 10 PMID 38332750

Identifiers

NCT: NCT07589985 · IRB-300003590 · R37AI179640 · R01AI147727 · R01AI195435 · 316-2019

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗