What side effects are associated with this type of intervention?

Common treatments for Multiple Sclerosis (MS) include disease-modifying therapies such as fingolimod, glatiramer acetate, and dimethyl fumarate. Fingolimod can cause side effects like headache, elevated liver enzymes, diarrhea, cough, flu, sinusitis, back pain, abdominal pain, and pain in the arms or legs. It also increases the risk of bradyarrhythmia, macular edema, liver injury, diminished respiratory function, tumor development, and opportunistic infections. Glatiramer acetate may cause local injection site reactions, chest pain, and rarely, hepatotoxicity. Dimethyl fumarate is associated with flushing, gastrointestinal events, and lymphopenia. While Truvada (tenofovir/emtricitabine) is being studied for its antiviral activity against Epstein-Barr virus in MS, its side effects include gastrointestinal issues, renal toxicity, and bone density loss.

What prior FDA approvals exist?

The FDA has approved several disease-modifying therapies for the treatment of Multiple Sclerosis (MS). While Truvada (tenofovir/emtricitabine) is being studied for its antiviral activity against Epstein-Barr virus in MS, other antiviral treatments specifically for MS are not commonly highlighted. Approved treatments for MS include interferon beta-1a, glatiramer acetate, fingolimod, dimethyl fumarate, and alemtuzumab, among others. These therapies primarily focus on modulating the immune system to reduce relapse rates and slow disease progression. Fingolimod, for example, is an oral therapy that has shown efficacy in reducing relapses and new brain lesions. Glatiramer acetate is another well-established treatment that modulates the immune response to myelin antigens.

What other types of research exist?

Currently, there are no specific novel antiviral alternatives to Truvada (tenofovir/emtricitabine) with proven efficacy against Epstein Barr virus (EBV) for Multiple Sclerosis (MS) patients. However, MS patients may consider disease-modifying therapies (DMTs) such as alemtuzumab, natalizumab, and glatiramer acetate for managing their condition. Consultation with a healthcare provider is essential to explore the most appropriate treatment options based on individual patient needs and emerging research.

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Antiviral

Antiviral Therapy for Multiple Sclerosis

Phase 2

Waitlist Available

Led By Michael Levy, MD, PhD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline at three months

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

Truvada may cause side effects such as digestive issues, headaches, dizziness, fatigue, skin rashes or allergic reactions. Kidney problems are also a concern which will be monitored during the trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline at three months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline at three months

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline at three months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Epstein Barr virus (EBV) viral load

Secondary study objectives

Fatigue

Tolerability of Truvada (tenofovir/emtricitabine)

Side effects data

From 2010 Phase 4 trial • 60 Patients • NCT00885664

92%

Fatigue

46%

Night Sweats

35%

Fevers

23%

Nausea

19%

Diarrhea

12%

Anxiety

Peripheral neuropathy

100%

80%

60%

40%

20%

Study treatment Arm

Truvada/Kaletra CD4<100

Truvada/Kaletra CD4>/=100

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Truvada (tenofovir/emtricitabine)

2005

Completed Phase 4

~60

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Multiple Sclerosis (MS) treatments primarily work by modulating the immune system to reduce inflammation and prevent further damage to the nervous system. Common treatments include beta interferons and glatiramer acetate, which help reduce the frequency of relapses by altering immune function. More aggressive treatments like alemtuzumab and natalizumab target specific immune cells to prevent them from attacking the nervous system. Antiviral therapies, such as Truvada (tenofovir/emtricitabine), are being studied for their potential to reduce Epstein-Barr virus (EBV) levels, as EBV is suspected to play a role in MS pathogenesis. Understanding these mechanisms is crucial for MS patients as it helps tailor treatments to reduce disease activity and manage symptoms effectively.

Mode of action and clinical studies with alemtuzumab.Disease-modifying treatments for progressive multiple sclerosis.