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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether the antiviral drug Truvada can lower Epstein Barr virus (EBV) levels in people with multiple sclerosis (MS). Researchers aim to determine if Truvada is safe and manageable for those with MS. The trial seeks participants diagnosed with multiple sclerosis who show signs of EBV infection. Participants will first undergo a month without the drug, followed by three months of taking Truvada. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that Truvada (tenofovir/emtricitabine) is likely to be safe for humans?

Research has shown that Truvada, a combination of tenofovir and emtricitabine, is generally safe for people. The FDA has approved Truvada for treating HIV and chronic hepatitis B, providing extensive safety information.

In previous studies, participants taking Truvada for these conditions usually tolerated it well. Common side effects include fever, sweats, chills, and muscle aches. Serious side effects are rare but can affect the liver or kidneys.

Researchers are now studying whether Truvada can help people with MS by reducing a virus linked to the condition. As this study is in its early stages, it primarily focuses on the safety of Truvada for people with MS. The safety data from its use in other conditions guides the study in monitoring side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for multiple sclerosis, which often focus on modulating the immune system, Truvada is unique because it uses antiviral agents, tenofovir and emtricitabine, which are typically used to treat HIV and hepatitis B. Researchers are excited about Truvada because it targets viral elements that might play a role in multiple sclerosis, offering a novel approach to treatment. This new mechanism of action could provide benefits that current therapies do not, potentially opening up new avenues for managing the condition.

What evidence suggests that Truvada might be an effective treatment for multiple sclerosis?

Research has shown that Truvada, a drug used to fight viruses, might help reduce the activity of multiple sclerosis (MS). One case study revealed that an HIV-positive patient with MS experienced less disease activity while using a treatment that included tenofovir, a key component of Truvada. Additionally, evidence suggests that people with HIV have a lower risk of developing MS, indicating that antiviral treatments like Truvada could be beneficial. Truvada is already approved for treating HIV, and its safety profile is well established. This trial will evaluate Truvada's potential to manage MS by targeting the Epstein-Barr virus, which researchers believe is involved in the disease. ^{2 3 5 6 7}

Who Is on the Research Team?

Michael Levy, MD, PhD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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® (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]

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]

Citations

1. neurologylive.com neurologylive.com/view/case-study-reports-positive-impact-antiviral-therapy-tenofovir-ms-warranting-further-research

Case Study Reports Positive Impact of Antiviral Therapy ... In a case report, an HIV-positive patient with active multiple sclerosis showed reduced disease activity with tenofovir-containing ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6453722/

Review of real-world implementation data on emtricitabine ... Review of real-world implementation data on emtricitabine-tenofovir disoproxil fumarate as HIV pre-exposure prophylaxis in the United States - PMC.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05957913

Effects of Antiviral Therapies on Epstein-Barr Virus ... A second goal is to find out if Truvada (tenofovir/ emtricitabine) is safe and tolerable in people with MS. Detailed Description. The proposed trial is built on ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7650072/

Human immunodeficiency virus and multiple sclerosis Recent epidemiological studies indicated a negative association between MS and HIV in terms of a reduced risk of developing MS in HIV positive patients.

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/hiv.13728

Effectiveness, safety, and patient‐reported outcomes of ... Overall treatment persistence at M24 was 81% (E/C/F/TAF: 88%; R/F/TAF: 86%; F/TAF + 3rd agent: 70%, with ART simplification of multiple-tablet ...

6. fda.gov fda.gov/files/advisory%20committees/published/Truvada%C2%AE-Safety-and-Utilization-Review.pdf

Truvada® Safety and Utilization Review This review was prompted by pediatric labeling approved on 08-Jul-2011 which expanded the indication for the treatment of HIV-1 infection to ...

7. webmd.com webmd.com/drugs/2/drug-91482/truvada-oral/details

Emtricitabine/Tenofovir Disoproxil Fumarate (Truvada) What are the serious side effects of emtricitabine/tenofovir disoproxil fumarate? · Fever, sweats, chills, or muscle aches · Swollen lymph nodes · Vision problems ...