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The DELTA-EBV study
EU CTIS ID: 2025-522781-77-01
What this study is testing
The main objective of the study is to determine the safety and tolerability of a sequential dose escalation regimen of TAF (25mg, 50mg, and 100mg) in healthy individuals
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥ 18 to ≤ 65 years, both male and female participants.
- Positive serological testing for EBNA1 or VCA IgG.
- Creatinine clearance (CrCL) >= 80 mL/min.
- EBV-positive otherwise healthy individuals
- Women of childbearing potential (WOCBP) able and willing to use highly effective methods of birth control3 that result in a low failure rate of less than 1% per year when used consistently for the duration of the study + 7 days after last dose to comply with CTCG Contraception guidance Version 1.2 (CTCG 07.03.2024).
- Able and willing to perform all study procedures, including at-home saliva collection, for the duration of the study
You likely can't join if
- Known hypersensitivity or severe adverse reactions to the study medication’s active agent or other component.
- Platelet (thrombocyte) count < 100 x 10^9/L.
- ALAT over the upper normal reference limit.
- Serum creatinine over the upper normal reference limit.
- Serum bilirubin over the upper normal reference limit.
- Any other disease that can influence participant safety and compliance or the evaluation of the outcome.
See the full eligibility criteria
- Age ≥ 18 to ≤ 65 years, both male and female participants.
- Positive serological testing for EBNA1 or VCA IgG.
- Creatinine clearance (CrCL) >= 80 mL/min.
- EBV-positive otherwise healthy individuals
- Women of childbearing potential (WOCBP) able and willing to use highly effective methods of birth control3 that result in a low failure rate of less than 1% per year when used consistently for the duration of the study + 7 days after last dose to comply with CTCG Contraception guidance Version 1.2 (CTCG 07.03.2024).
- Able and willing to perform all study procedures, including at-home saliva collection, for the duration of the study
- Negative hepatitis B serology defined as hepatitis B surface antigen (HBsAg) negative and Hepatitis B core antibody (anti-HBc) negative.
- Known hypersensitivity or severe adverse reactions to the study medication’s active agent or other component.
- Platelet (thrombocyte) count < 100 x 10^9/L.
- ALAT over the upper normal reference limit.
- Serum creatinine over the upper normal reference limit.
- Serum bilirubin over the upper normal reference limit.
- Any other disease that can influence participant safety and compliance or the evaluation of the outcome.
- Currently enrolled in another investigational drug trial, or within 30 days of completing one. Participants are excluded until systemic exposure has cleared, defined as 5.5 half-lives or 30 days, whichever is longer
- Women who are pregnant, as verified by a serum pregnancy test at screening and during follow-up, or lactating.
- Any known ongoing infection with HIV, chronic active hepatitis, hepatitis C, or hepatitis B surface antigen positivity.
- Participants with any evidence of current or prior hepatitis B infection (including anti-HBc positivity) will be excluded to eliminate the risk of viral reactivation or flare following discontinuation of study treatment
- History of pancreatitis.
- Prior or current disorders influence the participant’s ability to give informed consent or to comply with treatment and follow-up of the protocol.
- Current users of medications that could interact with the study medication (listed in paragraph 5.6).
- Participants previously treated with hematopoietic stem cell transplantation (HSCT).
- Participants who previously have been treated with any chemotherapeutic medication.
- WBC < 1.5 x 10^9/L if not caused by a reversible effect of documented ongoing medication. If WBC < 1.5 x 10^9/L is caused by a reversible effect of documented ongoing medication the WBC count must be > 1.5 x 10^9/L before start of study treatment.
- History of liver disease
- History of kidney disease
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.