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Dosing EvaLuation of Tenofovir Alafenamide on Epstein-Barr Virus (The DELTA-EBV study)

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-522781-77-01
Enrollment
45
Registered
2026-05-28
Start date
Unknown
Completion date
Unknown
Last updated
2026-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epstein-Barr virus infection

Brief summary

Number of participants experiencing treatment-emergent adverse events (AEs).

Detailed description

Within-participants changes in EBV shedding frequency in saliva, defined as number of samples with detectable levels of EBV during sequential dose escalation., Within-participant changes in EBV viral load in saliva during sequential dose escalation., Within-participant changes in EBV specific CD4 T cells by ELISPOT assay during sequential dose escalation., Within-participant changes in IgG antibodies to EBNA1 and VCA during sequential dose escalation., Secondary safety endpoints related to the IMP

Interventions

Sponsors

Helse Bergen HF
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Number of participants experiencing treatment-emergent adverse events (AEs).

Secondary

MeasureTime frame
Within-participants changes in EBV shedding frequency in saliva, defined as number of samples with detectable levels of EBV during sequential dose escalation., Within-participant changes in EBV viral load in saliva during sequential dose escalation., Within-participant changes in EBV specific CD4 T cells by ELISPOT assay during sequential dose escalation., Within-participant changes in IgG antibodies to EBNA1 and VCA during sequential dose escalation., Secondary safety endpoints related to the IMP

Outcome results

None listed

Source: EU CTIS · Data processed: May 29, 2026