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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
Study Summary
This trial is testing if a drug can reduce Epstein-Barr virus levels in people with MS, and if it's safe and tolerable for them.
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.Check my eligibility
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.See study design
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Epstein Barr virus (EBV) viral load
Secondary outcome measures
Fatigue
Tolerability of Truvada (tenofovir/emtricitabine)
Side effects data
From 2010 Phase 4 trial • 60 Patients • NCT0088566492%
Fatigue
46%
Night Sweats
35%
Fevers
23%
Nausea
19%
Diarrhea
12%
Anxiety
4%
Peripheral neuropathy
100%
80%
60%
40%
20%
0%
Study treatment Arm
Truvada/Kaletra CD4<100
Truvada/Kaletra CD4>/=100
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
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
2,928 Previous Clinical Trials
13,198,305 Total Patients Enrolled
9 Trials studying Multiple Sclerosis
1,919 Patients Enrolled for Multiple Sclerosis
Solving MSUNKNOWN
Michael Levy, MD, PhDPrincipal InvestigatorMassachusetts General Hospital
9 Previous Clinical Trials
200 Total Patients Enrolled
1 Trials studying Multiple Sclerosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I am not taking any medication that interacts with Truvada.I have had bone fractures without any injury.I have been diagnosed with moderate to severe low phosphate levels.I have tested positive for Epstein Barr virus.I am not taking medication that affects EBV replication.I am willing and able to follow all study rules and be available for its duration.I have previously been treated with Truvada or Descovy.I do not have severe ongoing health issues that would make joining this study risky.I am 18 years old or older.I have been diagnosed with multiple sclerosis.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Multiple Sclerosis Patient Testimony for trial: Trial Name: NCT05957913 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What potential risks are associated with the Treatment arm protocol?
"Treatment arm was given a score of 2 as it is currently in the Phase 2 trial stage, meaning that there are safety metrics but no evidence for efficacy."
Answered by AI
Are there any open enrollment opportunities for the trial at this time?
"As per the information available on clinicaltrials.gov, this particular trial is not actively enrolling participants at present. It was initially posted in June 5th 2023 and had its last update on July 14th of that same year. However, there are a total of 432 other trials searching for volunteers right now."
Answered by AI
Who else is applying?
What state do they live in?
Florida
What site did they apply to?
Massachusetts General Hospital
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I have PPMS and there are limited treatment options. I am hesitant to start Ocrevus, but might soon.
PatientReceived 2+ prior treatments
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