A Pilot Trial of Herpesvirus Treatment in Idiopathic Pulmonary Fibrosis (IPF)
Status:
Completed
Trial end date:
2020-01-31
Target enrollment:
Participant gender:
Summary
The investigators will conduct a single-center, prospective, randomized, placebo-controlled,
double-blind pilot study of anti-herpesvirus therapy in patients with idiopathic pulmonary
fibrosis (IPF). Patients with mild, moderate or severe IPF with serologic evidence of current
or past Epstein-Barr Virus (EBV) or cytomegalovirus (CMV) infection. Randomization will be to
pirfenidone plus placebo or pirfenidone plus valganciclovir. Thirty subjects will be enrolled
and randomized to treatment with pirfenidone plus valganciclovir (20 subjects) or pirfenidone
plus placebo (10 subjects) for 12 weeks. The primary outcome will be safety and tolerability
will be determined by type, frequency and duration of adverse events (AEs) and serious
adverse events (SAEs) after 12 weeks of study drug treatment. All study subjects will be
offered bronchoscopy with bronchoalveolar lavage (BAL) at study initiation and upon
completion of treatment (12 weeks). Subjects will then be followed up at routine clinic
visits at 6, 9 and 12 months for data collection.
Phase:
Phase 1
Details
Lead Sponsor:
Vanderbilt University Vanderbilt University Medical Center