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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
Must not have
Dysphagia to food or pills
GI surgery within 3m, Crohn's disease, diverticulitis, any electromechanical medical device (e.g. pacemaker, infusion pump).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have trouble swallowing food or pills.
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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.
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I have a blockage in my digestive system.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Gastric pH measurement
Hydrogen/methane breath testing (hbt)
Small bowel transit time (SBTT)

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

Find a Location

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
904 Previous Clinical Trials
541,655 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,448 Previous Clinical Trials
4,332,269 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

Non-invasive Vagal Nerve Stimulation Clinical Trial Eligibility Overview. Trial Name: NCT04353778 — Phase 1 & 2
HIV/AIDS Research Study Groups: PLWH, Healthy Controls, Pyridostigmine, Placebo, nVNS
HIV/AIDS Clinical Trial 2023: Non-invasive Vagal Nerve Stimulation Highlights & Side Effects. Trial Name: NCT04353778 — Phase 1 & 2
Non-invasive Vagal Nerve Stimulation 2023 Treatment Timeline for Medical Study. Trial Name: NCT04353778 — Phase 1 & 2
~6 spots leftby Jan 2025
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