Status:
WITHDRAWN
Tenofovir Alafenamide for Treatment of Symptoms and Neuroprotection in Relapsing Remitting Multiple Sclerosis
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Gilead Sciences
Conditions:
Multiple Sclerosis, Relapsing-Remitting
Fatigue
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
As the in vivo reservoir of the Epstein-Barr virus, B cells play an important role in the perpetuation of MS disease activity. B cell depletion therapy with medications like ocrelizumab or rituximab h...
Eligibility Criteria
Inclusion
- Provision of signed and dated informed consent form
- Stated willingness and ability to comply with all study procedures and availability for the duration of the study
- Aged 18+ years
- Diagnosis of MS using revised 2010 McDonald criteria of clinically definite MS.
- Receiving treatment with either ocrelizumab or rituximab on a regular twice-yearly schedule. The first infusion must have been received at least 6 months before enrollment.
- Must report significant fatigue during the past 3 months not due to a cause other than MS.
- For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation.
- For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner.
Exclusion
- Pregnancy or lactation
- Known allergic reactions to components of TAF
- Treatment with another investigational drug or other MS-directed intervention such as glatiramer acetate, or dimethyl fumarate within 3 months
- Positive HIV antibody test, active or latent hepatitis B
- Relapse and/or steroid treatment within the previous 30 days
- Baseline EDSS \> 7
- Current symptoms of severe, progressive, or uncontrolled renal, hematologic, gastrointestinal, pulmonary, cardiac, or neurologic disease, or other medical conditions that, in the opinion of the Investigator, might place the subject at unacceptable risk for participation in this study
- Known history of sleep apnea, narcolepsy, or other significant sleep disorders
- Recent changes to medications affecting sleep or fatigue or changes in dosage of those medications within 90 days
- Creatinine clearance (CrCl) \<55mL/min, as calculated by the Cockcroft-Gault equation
- Taking medication with known interactions with tenofovir alafenamide including: Acyclovir, valacyclovir, adefovir, cabozantinib, carbamazepine, cidofovir, cladribine, cobicistat, diclofenac, multiple NSAIDs or chronic high dose NSAIDs, fosphenytoin or phenytoin, ganciclovir, valganciclovir, oxcarbazepine, phenobarbital, primidone, rifabutin, rifampin, rifapentine, sofosbuvir, tipranavir
Key Trial Info
Start Date :
September 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 14 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04880577
Start Date
September 15 2022
End Date
February 14 2025
Last Update
November 15 2022
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114