Effects of Antiviral Therapies on Epstein-Barr Virus Replication

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT05957913
Phase
PHASE2
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Truvada (tenofovir/emtricitabine) — DRUG
    Doses and route of administration of the study drug will be kept the same as for the FDA-approved indication of HIV-1 prevention in healthy individuals. The study drug is not FDA-approved for the treatment of multiple sclerosis.

Study Details

This research study is being performed to find out if Truvada (tenofovir/emtricitabine), an antiviral drug with activity against the Epstein Barr virus (EBV), can reduce EBV levels in saliva and blood in people with multiple sclerosis (MS). A second goal is to find out if Truvada (tenofovir/ emtricitabine) is safe and tolerable in people with MS.

Key Dates

Start date
Jun 5, 2023
Status verified
Oct 2025
Primary completion
Jun 4, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Treatment arm
    After a one-month baseline period where patients will not take any study drug, all patients will receive Truvada (tenofovir/emtricitabine) for three months. The study drug will be Truvada (tenofovir/emtricitabine), an antiviral drug that is approved by the Food \& Drug Administration (FDA) for the treatment of chronic hepatitis B virus and for the treatment and prevention of human immunodeficiency virus (HIV) infection. The study drug will be administered at the standard dose used for the treatment and prevention of HIV (300mg tenofovir disoproxil fumarate, 200mg emtricitabine). Since extensive safety and tolerability data already exists for this standard dose, the selection of this dose also allows us to use existing data to inform strategies for safety and tolerability monitoring to minimize risk, as detailed in the study design.

Primary Outcome Measure

Epstein Barr virus (EBV) viral load [ Time Frame: Change from baseline at three months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114-

Find similar trials in Boston, MA

By condition
Multiple sclerosis
By specialty
NeurologyBrain disordersAutoimmune disease
By research site
Massachusetts General Hospital· Boston, MA

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