Prevention of Recurrence of Herpes Simplex in Autoimmune Rheumatic Diseases
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age12+
SponsorUniversity of Sao Paulo General Hospital
About this trial
The goal of this randomized, double-blind, placebo-controlled clinical trial is to evaluate the effectiveness and safety of oral suppressive therapy with acyclovir in preventing herpes simplex virus (HSV) reactivation in patients with autoimmune rheumatic diseases (ARDs) who have a history of recurrent HS episodes.
The main questions this study aims to answer are:
Does continuous oral acyclovir reduce the frequency of HSV reactivation in ARD patients compared to placebo? What is the safety profile of prolonged acyclovir use in this population? What are the main risk factors (clinical and treatment-related) associated with HSV reactivation in immunosuppressed patients.
Participants will:
Be randomly assigned (1:1) to receive oral acyclovir (400 mg BID) or placebo for 12 months; Be followed for a total of 24 months, with regular clinical evaluations (every 3 months) and laboratory monitoring (every 3 months); Be assessed for HSV recurrence based on clinical symptoms, detection of HSV DNA by polymerase chain reaction (PCR) in mucocutaneous swabs in doubtful cases, and standardized reporting forms; Undergo disease activity assessments and adverse event monitoring at regular intervals.
The study includes adult and pediatric patients with confirmed diagnoses of one of the following ARDs: systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), ankylosing spondylitis (AS), psoriatic arthritis (PsA), dermatomyositis/polymyositis (DM/PM), systemic sclerosis (SSc), systemic vasculitis, primary Sjögren's syndrome, Mixed connective tissue disease (MCTD), Chronic recurrent multifocal osteomyelitis (CRMO), Sarcoidosis and Behçet's Syndrome. All participants must have a documented history of recurrent HSV (oral and/or genital) before inclusion.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Acyclovir (ACV)
DrugOral acyclovir 400 mg twice a day for 12 months. Acyclovir is a synthetic nucleoside analog with in vitro activity against HSV-1, HSV-2, VZV, and other herpesviruses.
Placebo
Other interventionMatching oral placebo, administered twice a day for 12 months.
Treatment groups
62 Participants
are divided into 2 treatment groupsGroup A: ACVActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
HSV Reactivation Rate
Proportion of patients with autoimmune rheumatic diseases (ARDs) and history of recurrent HS who experience clinical reactivation of HSV (oral and/or genital) during the 12-month treatment period and during the following 12 months. Reactivation will be defined by clinical signs and symptoms of HS, detection of HSV DNA by PCR in mucocutaneous swabs in doubtful cases.
Time frame
Baseline to Month 24Secondary outcomes
1
Safety Profile - Adverse Events (AEs)
Frequency and severity of adverse events (e.g., gastrointestinal discomfort, headache, rash) reported during the 12-month treatment phase.
Time frame
Day 1 through Month 122
Frequency of Serious Adverse Events (SAEs)
Incidence of SAEs (hospitalization, death, drug-related complications) in the acyclovir and placebo groups.
Time frame
Day 1 through Month 123
Treatment Discontinuation Due to AEs
Proportion of participants who discontinue acyclovir or placebo due to adverse events.
Time frame
Day 1 through Month 124
Time to First HSV Reactivation
Number of days from randomization to first documented HSV reactivation.
Time frame
Day 1 through Month 12Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Sao Paulo General Hospital
Lead sponsor
Fundação de Amparo à Pesquisa do Estado de São Paulo
Collaborator
Source ClinicalTrials.gov