Preventing HSV flares in people with autoimmune rheumatic diseases
Official title: Prevention of Recurrence of Herpes Simplex in Patients With Autoimmune Rheumatic Diseases
Run by University of Sao Paulo General Hospital · NCT07341386 · Data updated 2026-11-12
This trial tests whether taking acyclovir every day for a year can reduce herpes simplex recurrences in people with autoimmune rheumatic diseases who have a history of frequent HSV episodes.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 12 Years and up |
| Sex | All |
| Enrollment | 62 (estimated) |
| Sponsor | University of Sao Paulo General Hospital Academic / other |
| Locations | 1 site (São Paulo, São Paulo) |
| Status | Recruiting |
| Started | June 25, 2026 |
| Main results expected | April 1, 2027 |
| Study ends | April 1, 2028 |
| Registry record updated | August 5, 2026 |
| Trial ID | NCT07341386 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals aged 12 or older with an autoimmune rheumatic disease and a documented history of recurrent HSV infections, currently on immunosuppressive therapy.
✕Probably not a fit
Patients without a history of recurrent HSV or those who cannot take acyclovir due to safety concerns may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a randomized, double-blind, placebo-controlled study conducted over 24 months. Participants with autoimmune rheumatic diseases and prior recurrent HSV will be assigned to oral acyclovir 400 mg twice daily or placebo for 12 months and then monitored for an additional year. The primary outcome is the number of clinically confirmed HSV reactivations; safety and tolerability are also assessed, along with risk factors for recurrence. The study aims to provide high-quality evidence on the effectiveness and safety of long-term suppressive antiviral therapy in this immunosuppressed population.
Why it matters
Potential benefit: If successful, patients may experience fewer HSV recurrences and better overall quality of life due to fewer outbreaks.
How similar studies have gone: Prior studies in other populations suggest acyclovir can reduce HSV-related complications, but this is the first randomized trial in ARD patients.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria * Eligible participants must be \>12 years old * Any sex * Have a confirmed diagnosis of an autoimmune rheumatic disease (ARD) based on internationally accepted classification criteria, including: rheumatoid arthritis (ACR/EULAR 2010), juvenile idiopathic arthritis (ILAR), axial spondyloarthritis (ASAS 2009), psoriatic arthritis (CASPAR 2012), systemic lupus erythematosus (SLICC 2012), systemic sclerosis (ACR 2013), dermatomyositis/polymyositis (Bohan \& Peter), systemic vasculitis (Takayasu arteritis, granulomatosis with polyangiitis, polyarteritis nodosa), primary Sjögren's syndrome (ACR/EULAR 2016), mixed connective tissue disease (Alarcón-Segovia or Kasukawa criteria), chronic recurrent multifocal osteomyelitis (Jansson et al., 2007), sarcoidosis (ATS/ERS/WASOG 2020 statement) and behçet's syndrome (International Study Group, 1990). * Present serologic evidence of prior HSV infection (complement fixation titer ≥ 1:8) * A clinical history of recurrent oral or genital herpes simplex virus infection, defined as at least four episodes in the past 12 months. Exclusion Criteria -Participants will be excluded if they have a known hypersensitivity to acyclovir or any component of the study medication.
Where it's running
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Reumatology division of Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo, Sao Paulo, Sao Paulo 05403-000
São Paulo, São Paulo, Brazil Recruiting
Study contacts
- Study coordinator: Eloisa Bonfá Full Professor
- Email: reumatologia.fmusp@hc.fm.usp.br
- Phone: (11) 3061-7492
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.