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Medication + Nerve Stimulation for HIV (EVA Trial)
Phase 1 & 2
Recruiting
Led By Jessica Robinson-Papp, MD
Research Sponsored by Icahn School of Medicine at Mount Sinai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
No diagnosis known to cause autonomic or GI dysfunction other than HIV (e.g. Parkinson's disease, diabetes, peptic ulcer disease, infectious diarrhea)
Stable CART for greater or equal to 3 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
EVA Trial Summary
This trial will study whether a medication and nerve stimulation can help treat inflammation in people with HIV.
Who is the study for?
This trial is for adults with HIV who have a stable treatment regimen, no drug use or pregnancy, and no other conditions affecting the nervous system or gastrointestinal tract. Participants must not smoke for 24 hours before tests and can't be on certain medications that affect the autonomic system or digestion.Check my eligibility
What is being tested?
The study examines if pyridostigmine medication and non-invasive vagal nerve stimulation can improve gut health and reduce inflammation in people with HIV. It explores how vagus nerve dysfunction might contribute to these issues.See study design
What are the potential side effects?
Potential side effects of pyridostigmine may include muscle cramps, weakness, diarrhea, nausea, vomiting; while vagal nerve stimulation could cause voice changes, coughing, tingling sensation in the skin.
EVA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I don't have conditions like Parkinson's, diabetes, or ulcers that affect my digestion, except possibly HIV.
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My heart condition has been stable for at least 3 months.
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I am not taking any medications that strongly affect my nervous system or digestion.
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I am 18 years old or older.
EVA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Gastric pH measurement
Hydrogen/methane breath testing (hbt)
IL6 measurement. [Time Frame: 5 years]
+1 moreEVA Trial Design
5Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: nVNSExperimental Treatment1 Intervention
PLWH to undergo non-invasive vagal nerve stimulation
Group II: PLWHActive Control1 Intervention
People living with HIV (HIV)
Group III: Healthy ControlsActive Control1 Intervention
Healthy controls who do not have HIV
Group IV: PyridostigmineActive Control1 Intervention
PLWH on pyridostigmine 30mg PO TID
Group V: PlaceboPlacebo Group1 Intervention
PLWH on placebo
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Icahn School of Medicine at Mount SinaiLead Sponsor
860 Previous Clinical Trials
524,326 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,359 Previous Clinical Trials
4,315,345 Total Patients Enrolled
Jessica Robinson-Papp, MDPrincipal Investigator - Icahn School of Medicine at Mount Sinai
Icahn School of Medicine at Mount Sinai
4 Previous Clinical Trials
362 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I don't have conditions like Parkinson's, diabetes, or ulcers that affect my digestion, except possibly HIV.I have trouble swallowing food or pills.I haven't had GI surgery in the last 3 months, don't have Crohn's or diverticulitis, and don't use devices like pacemakers.I have no history of brain issues, abnormal neck anatomy, or recent VNS.I cannot take pyridostigmine due to certain health conditions or allergies.My heart condition has been stable for at least 3 months.I am not taking any medications that strongly affect my nervous system or digestion.I have a blockage in my digestive system.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: PLWH
- Group 2: Healthy Controls
- Group 3: Pyridostigmine
- Group 4: Placebo
- Group 5: nVNS
Awards:
This trial has 0 awards, including: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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
In what situations is Pyridostigmine generally utilized?
"Pyridostigmine is used to manage symptoms of myasthenia gravis, dyschezia, orthostatic syncope, and non-depolarizing neuromuscular blocking agents."
Answered by AI
Could you share the aggregate figure of participants enrolled in this research endeavor?
"Indeed, clinicaltrials.gov attests that this research project is actively recruiting participants. This trial was published on August 3rd 2020 and has since been modified on April 12th 2022. The study necessitates 250 test subjects from a single medical site."
Answered by AI
Is enrollment for this experiment currently available to participants?
"Affirmative. According to information hosted on clinicaltrials.gov, this study is presently seeking participants--the trial was first published on August 3rd 2020 and the most recent update occurred on April 12th 2022. The experiment has allocated 250 slots across one medical site."
Answered by AI
Are there pre-existing studies that utilize Pyridostigmine?
"At present, 4 clinical trials investigating the effects of Pyridostigmine are being conducted. Unfortunately, none of these investigations have advanced to Phase 3. Nevertheless, individuals in Nashville, Tennessee and its surrounding areas can access numerous research sites that offer this medical intervention."
Answered by AI
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