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Virus Therapy
Valacyclovir + Shingrix for Achalasia
Nashville, TN
Phase 4
Recruiting
Led By Michael Vaezi, MD
Research Sponsored by Vanderbilt University Medical Center
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 one year
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
Summary
This trial will explore how chickenpox/shingles virus can cause a gastrointestinal disorder, and if it's linked to a severe esophagus disease.
See full description
Who is the study for?
This trial is for men and women aged 18-75 with achalasia, a condition that makes swallowing difficult. Participants must be fluent in English, able to give consent, and undergo specific diagnostic tests. Women of childbearing age should use effective birth control.
What is being tested?
The study aims to treat achalasia by targeting the varicella zoster virus (VZV), which may cause it. It involves taking ValACYclovir pills three times daily and receiving two Shingrix injections over two months.See study design
What are the potential side effects?
Possible side effects include headache, nausea, stomach pain from ValACYclovir; redness, soreness at injection site, muscle pain, fatigue from Shingrix. Individual reactions can vary.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ one year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Esophageal Achalasia
Secondary study objectives
Difference in viral loads in achalasia phenotype II versus phenotype III
Genetic typing of reactivation of VZV in the esophagus
Incidence of reactivation of VZV due to mast cell degranulation
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment2 Interventions
Patients with Achalasia (phenotypes II and III) with VZV DNA in saliva. Patients will be treated with valacyclovir 3 times per day. Patients found to benefit from treatment with valacyclovir will be offered Shingrix vaccine (2 - 0.5mL doses)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Shingrix
2019
Completed Phase 4
~600
Find a Location
Closest Location:Vanderbilt University Medical Center· Nashville, TN· 337 miles
Who is running the clinical trial?
Vanderbilt University Medical CenterLead Sponsor
919 Previous Clinical Trials
938,719 Total Patients Enrolled
2 Trials studying Achalasia
100 Patients Enrolled for Achalasia
Columbia UniversityOTHER
1,526 Previous Clinical Trials
2,831,411 Total Patients Enrolled
Michael Vaezi, MDPrincipal InvestigatorVanderbilt University Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with achalasia and am fit for treatment.My chronic conditions like high blood pressure or diabetes are well-managed.I do not have any brain or thinking problems that would stop me from joining a study.I have been diagnosed with achalasia and am fit for treatment.I am between 18 and 75 years old. If I can have children, I use effective birth control.I can undergo specific swallowing tests, a nasal procedure for esophagus testing, and follow a 2-month treatment plan including medication and vaccinations.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.