Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2023 Aug 24;9(3):100344.
doi: 10.1016/j.jve.2023.100344. eCollection 2023 Sep.

Design and analysis considerations for early phase clinical trials in hepatitis B (HBV) cure research: the ACTG A5394 study in persons with both HIV and HBV

Minhee Kang  1 , Jennifer C Price  2 , Marion G Peters  3 , Sharon R Lewin  4   5   6 , Mark Sulkowski  7
Affiliations

Design and analysis considerations for early phase clinical trials in hepatitis B (HBV) cure research: the ACTG A5394 study in persons with both HIV and HBV

Minhee Kang et al. J Virus Erad. .

Abstract

With growing interest and efforts to achieve a hepatitis B (HBV) cure, HBV therapeutics have increasingly entered the clinical testing phase. In designing an early phase clinical trial aimed at HBV cure, the heterogeneity in participants and the choice of a biomarker endpoint that signals a cure requires careful consideration. We describe the key elements to consider during the development of HBV clinical trials aimed at a functional cure, and how we have addressed them in the design of a phase II AIDS Clinical Trials Group (ACTG) study, A5394 (NCT05551273). The trial we present is for persons with both HIV and HBV, a unique population that has much to gain from an HBV cure. Our decisions on the design elements are specific to the study agent and the targeted population, but our deliberations may be informative in the emerging field of early phase HBV trials aimed at cure.

Keywords: Clinical trial design; Cure; HBV; HIV; Placebo; TLR agonist.

PubMed Disclaimer

Conflict of interest statement

The author authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Similar articles

See all similar articles

Cited by

References

    1. Block T.M., Chang K.M., Guo J.T. Prospects for the global elimination of hepatitis B. Annu Rev Virol. 2021;8(1):437–458. - PubMed
    1. Liang T.J., Block T.M., McMahon B.J., et al. Present and future therapies of hepatitis B: from discovery to cure. Hepatology. 2015;62(6):1893–1908. doi: 10.1002/hep.28025. - DOI - PMC - PubMed
    1. Martinez M.G., Villeret V., Testoni B., Zoulim F. Can we cure hepatitis B virus with novel direct-acting antivirals? Liver. 2020;40(Suppl) - PubMed
    1. Dube K., Kanazawa J., Dee L., et al. Considerations for designing and implementing combination HIV cure trials: findings from a qualitative in-depth interview study in the United States. AIDS Res Ther. 2021;18(1):75. - PMC - PubMed
    1. Lewin S.R., Attoye T., Bansbach C., et al. Multi-stakeholder consensus on a target product profile for an HIV cure. Lancet HIV. 2021;8(1):e42–e50. - PMC - PubMed

LinkOut - more resources