Antiviral Therapy for Multiple Sclerosis

Recruiting in Palo Alto (17 mi)

Overseen byMichael Levy, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Massachusetts General Hospital

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing Truvada, an antiviral drug, to see if it can lower Epstein Barr virus levels in people with multiple sclerosis. The goal is to find a safer and more effective treatment for MS by targeting the virus. Truvada is already known to be safe from its use in treating HIV.

Research Team

Michael Levy, MD, PhD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

This trial is for adults over 18 with multiple sclerosis (MS) who have evidence of Epstein-Barr virus (EBV) infection. Participants must be willing to follow study procedures and not be pregnant or breastfeeding. They should not have allergies to Truvada, previous Truvada treatment, unknown HIV status, active hepatitis B, severe medical conditions as assessed by the investigator, certain blood abnormalities or take medications that interact with Truvada.

Inclusion Criteria

I have tested positive for Epstein Barr virus.

Provision of signed and dated informed consent form

I am willing and able to follow all study rules and be available for its duration.

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Exclusion Criteria

My kidney function, measured by creatinine clearance, is below 75 mL/min.

I have been tested for hepatitis B within the last 6 months.

Pregnancy or lactation

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Treatment Details

Interventions

Truvada (tenofovir/emtricitabine) (Antiviral)

Trial OverviewThe study tests if the antiviral drug Truvada can lower EBV levels in saliva and blood of MS patients and checks its safety and tolerability. It aims to understand if controlling EBV replication affects MS progression.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Treatment armExperimental Treatment1 Intervention

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.