Antiviral Therapy for Multiple Sclerosis

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Massachusetts General Hospital

Must not be taking: NSAIDs, Antivirals, Antiepileptics, others

Disqualifiers: Pregnancy, Hepatitis B, Renal disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

50 Participants Needed

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.

Will I have to stop taking my current medications?

You may need to stop taking certain medications if they interact with Truvada or affect EBV replication. These include drugs like Acyclovir, valacyclovir, and some NSAIDs. It's best to discuss your current medications with the study team to see if any changes are needed.

How does the drug Truvada differ from other treatments for multiple sclerosis?

Truvada, a combination of tenofovir and emtricitabine, is unique for multiple sclerosis as it is primarily an antiviral medication used for HIV and hepatitis B, unlike typical MS treatments that focus on modulating the immune system. Its use in MS is novel and experimental, exploring antiviral effects in a condition not traditionally treated with antivirals. ^{1 2 3 4 5}

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.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Participants undergo a one-month baseline period without taking any study drug

4 weeks

Treatment

Participants receive Truvada (tenofovir/emtricitabine) for three months

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Truvada (tenofovir/emtricitabine)

Trial Overview 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.

Participant Groups

Group I: Treatment arm Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Solving MS

Collaborator

Trials

1

Recruited

50+

Findings from Research

Truvada, a once-daily combination pill containing tenofovir disoproxil fumarate and emtricitabine, is expected to be an effective and low-toxicity treatment option for managing HIV, especially in developing countries.

While there is limited clinical efficacy data available, existing studies suggest that emtricitabine is as potent as lamivudine, and trials have shown that tenofovir combined with lamivudine is effective when paired with other antiretroviral medications for up to 96 weeks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of tenofovir disoproxil fumarate and emtricitabine combination in HIV-infected patients. Gazzard, BG.[2019]

Emtricitabine/tenofovir disoproxil fumarate (Truvada) has been approved as an effective preexposure prophylaxis (PrEP) therapy for adults at high risk of acquiring HIV through sexual contact.

The article reviews data that supports the efficacy of PrEP, highlighting its role in preventing HIV infection in high-risk populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preexposure prophylaxis: An emerging clinical approach to preventing HIV in high-risk adults. Blackwell, CW.[2015]

Truvada, a combination of tenofovir disoproxil fumarate and emtricitabine, is effective in treating HIV-1 and HIV-2, allowing for once-daily dosing due to its long half-life and favorable safety profile, including a lower incidence of fat loss compared to other treatments.

The combination has shown superior efficacy in clinical trials compared to other regimens, with a low incidence of resistance mutations, making it a reliable option in highly active antiretroviral therapy (HAART).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tenofovir disoproxil fumarate-emtricitabine coformulation for once-daily dual NRTI backbone. Muñoz de Benito, RM., Arribas López, JR.[2015]

Truvada® (tenofovir plus emtricitabine) is effective in reducing the risk of HIV infection in uninfected individuals who have stable sexual partners with HIV.

There is a growing concern that the use of Truvada® may lead to an increase in sexually transmitted infections among individuals with multiple partners, as they may develop a false sense of security regarding their sexual health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HIV Pre-Exposure Prophylaxis - Is it just about pills? Fernandez-Montero, JV.[2017]

References

1. England pubmed.ncbi.nlm.nih.gov

Use of tenofovir disoproxil fumarate and emtricitabine combination in HIV-infected patients. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Preexposure prophylaxis: An emerging clinical approach to preventing HIV in high-risk adults. [2015]

3. England pubmed.ncbi.nlm.nih.gov

Tenofovir disoproxil fumarate-emtricitabine coformulation for once-daily dual NRTI backbone. [2015]

4. England pubmed.ncbi.nlm.nih.gov

Is tenofovir/emtricitabine teratogenic? [2021]

5. Spain pubmed.ncbi.nlm.nih.gov

HIV Pre-Exposure Prophylaxis - Is it just about pills? [2017]