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Hep Mec Cohort in Zambia (Hep Mec)

9. maj 2026 opdateret af: Michael Vinikoor, University of Alabama at Birmingham
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.

Studieoversigt

Status

Rekruttering

Betingelser

Undersøgelsestype

Observationel

Tilmelding (Anslået)

390

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Michael J Vinikoor, MD
  • Telefonnummer: 205-934-5191
  • E-mail: mjv3@uab.edu

Undersøgelse Kontakt Backup

Studiesteder

  • Zambia
      • Lusaka, Zambia
        • Rekruttering
        • University Teaching Hospital
        • Kontakt:
        • Kontakt:
      • Lusaka, Zambia
        • Rekruttering
        • Kanyama Level 1 Hospital
        • Kontakt:
        • Kontakt:
      • Lusaka, Zambia
        • Rekruttering
        • Matero Level 1 Hospital
        • Kontakt:
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

This study will occur in Lusaka, Zambia, which has 12% adult HIV prevalence and ~4% adult HBsAg-positivity. Both HIV and HBV treatment are free and provided through the Ministry of Health. Tenofovir-based therapies are used for HBV monoinfection and HBV/HIV coinfection. Potential participants will be recruited from Ministry of Health (i.e., public sector) clinics at study sites including from a pool of participants in past HBV research projects. There are a 5 groups of participants we seek to enroll in the study, to facilitate addressing the scientific goals of the cohort.

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Intrahepatic Immune Cell Subset Frequencies
Tidsramme: Baseline and 1 year
Percentage of immune cell subsets (CD4+ T cells, CD8+ T cells, B cells, NK cells, Macrophages, and Neutrophils) among total liver immune cells as measured by single-cell RNA sequencing. Comparisons will be made between acute and chronic HBV infection, with and without HIV coinfection, and before and after nucleoside analog antiviral therapy.
Baseline and 1 year
Number of Differentially Expressed Hepatic Genes Associated with HBsAg Reduction/Loss
Tidsramme: Baseline and 1 year
Count of genes showing differential expression (fold change ≥2.0, adjusted p-value <0.05) by single-cell RNA sequencing in liver biopsies from participants achieving HBsAg loss compared to those without HBsAg loss. Gene expression will be analyzed at baseline (predictive analysis), longitudinally (trajectory analysis), and at end of follow-up. Analysis will include comparison across acute vs. chronic HBV infection and with vs. without HIV coinfection.
Baseline and 1 year

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
HBV viral suppression
Tidsramme: Baseline, 1 year, 2 years, 3 years, 4 years, and 5 years
Reduction of HBV DNA in blood to below detectable levels
Baseline, 1 year, 2 years, 3 years, 4 years, and 5 years
HIV viral suppression
Tidsramme: Baseline, 1 year, 2 years, 3 years, 4 years, and 5 years
HIV RNA suppression in blood below the level of assay detection
Baseline, 1 year, 2 years, 3 years, 4 years, and 5 years
HBsAg seroclearance
Tidsramme: Through study completion, an average of 5 years
Loss of hepatitis B surface antigen in blood samples
Through study completion, an average of 5 years
HBeAg seroconversion
Tidsramme: Through study completion, an average of 5 years
HBeAg-negativity in blood
Through study completion, an average of 5 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Alabama at Birmingham

Samarbejdspartnere

National Institute of Allergy and Infectious Diseases (NIAID)
Massachusetts General Hospital
Weill Medical College of Cornell University
Centre for Infectious Disease Research in Zambia
University of Zambia
Tropical Gastroenterology and Nutrition Group

Efterforskere

  • Ledende efterforsker: Michael Vinikoor, MD, University of Alabama at Birmingham

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

28. september 2020

Primær færdiggørelse (Anslået)

31. august 2029

Studieafslutning (Anslået)

31. august 2030

Datoer for studieregistrering

Først indsendt

5. februar 2026

Først indsendt, der opfyldte QC-kriterier

9. maj 2026

Først opslået (Faktiske)

15. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. maj 2026

Sidst verificeret

1. januar 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • IRB-300003590
  • R37AI179640 (U.S. NIH-bevilling/kontrakt)
  • R01AI147727 (U.S. NIH-bevilling/kontrakt)
  • R01AI195435 (U.S. NIH-bevilling/kontrakt)
  • 316-2019 (Anden identifikator: University of Zambia Biomedical Research Ethics Committee)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

All study results and anonymized participant data will be made publicly-available. The timing will be based on when analysis is completed and results are disseminated. The study also will adhere to Zambian laws around data protection and sharing.

IPD-delingstidsramme

Supporting information will be made available at study completion. IPD will be made available after completion of primary outcome analyses. We expect primary outcomes analyses will be completed in 2027, 2028, and 2029.

IPD-delingsadgangskriterier

During the study, only staff in Zambia and collaborating investigators will have access to IPD and supporting information. After the end of the study, this will be gradually made publicly available.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • ICF

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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