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Can stimulating a nerve calm HIV-Related inflammation?

NCT ID NCT04353778

Knowledge-focused Sponsor: Icahn School of Medicine at Mount Sinai Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Aug 19, 2026 · Updated 3 times

Summary

This study looks at how damage to the vagus nerve may cause gut issues and inflammation in people with HIV. Researchers will test two approaches—a drug called pyridostigmine and non-invasive vagus nerve stimulation—to see if they can improve gut function and reduce inflammation. The study involves 207 participants and aims to better understand these pathways.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
pyridostigmine
What this could lead to
If successful, this could point toward new ways to reduce inflammation and gut problems in people living with HIV.
What could go wrong
This is an early-phase study focused on understanding mechanisms, not proving a treatment works. The results may not lead to a direct therapy.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

215 people

The number who actually took part.

Started

Aug 2020

Finished

Mar 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria : * Greater than or equal to18 years old (18 to 64 Years, 65 Years and Over) * Documentation of HIV-1 infection * Stable CART for greater or equal to 3 months * HIV-1 viral load \<100 copies/ml (within 3m) * No diagnosis known to cause autonomic or GI dysfunction other than HIV (e.g. Parkinson's disease, diabetes, peptic ulcer disease, infectious diarrhea) * Willing to refrain from nicotine use for 24h prior to all testing * No contraindication to autonomic testing (e.g. uncontrolled glaucoma, heart rate not under sinus control) * No medications with significant autonomic or GI effects (e.g. sympathomimetics, prokinetics, anti-diarrheals, antibiotics) * Urine test negative for stimulants and opiates/opioids and pregnancy test (if applicable) Exclusion Criteria: * Dysphagia to food or pills * Known or suspected obstructive disease of the GI tract (e.g. bezoar, strictures, fistulae, physiologic GI obstruction) * GI surgery within 3m, Crohn's disease, diverticulitis, any electromechanical medical device (e.g. pacemaker, infusion pump). * Contraindication to pyridostigmine (e.g. mechanical intestinal or urinary obstruction, hypersensitivity to pyridostigmine, cardiac arrhythmias, asthma, chronic obstructive pulmonary disease); use of pyridostigmine within the past 6m. * History of intracranial aneurysm/hemorrhage, brain tumor, abnormal neck anatomy, or implants or metal hardware near site of stimulation; exposure to VNS within the past 6m.

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Conditions

The condition(s) this trial relates to.

HIV infectious disease vagus nerve disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HIV Non-HIV Vagus nerve dysfunction

Contacts and locations

Locations

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.