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Exploring Vagus Nerve Dysfunction in HIV

This study is looking into how problems with your vagus nerve (a long nerve that runs from your brain to your gut) might be linked to gut issues and inflammation in people living with HIV. Researchers want to see if a medication called pyridostigmine or non-invasive vagal nerve stimulation (a procedure to stimulate the vagus nerve) could be helpful treatments. You might be able to join if you are 18 or older, have HIV-1 that is well-controlled with stable medication for at least 3 months, and have a viral load below 100 copies/ml. The study will measure how quickly food moves through your small bowel, your stomach acid levels, and breath tests for gut bacteria after 8 weeks to see if the treatments are successful. The current recruitment status is unclear.

Study design
This is an interventional study with a planned enrollment of 207 participants. It will compare the effects of pyridostigmine, placebos, and non-invasive vagal nerve stimulation.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Primary endpoints are measured at 8 weeks after starting the intervention.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04353778

Effects of Vagal Dysfunction on Gastrointestinal and Inflammatory Pathways in HIV

Completed
PHASE1Ages 18+InterventionalTreatment
Icahn School of Medicine at Mount Sinai
~215 participants
Updated 2026-08-18 on ClinicalTrials.gov
What's tested:PyridostigminePlacebosnon-invasive vagal nerve stimulation

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Small bowel transit time (SBTT)
Measured over 8 weeks
+3 more outcomes measured

Conditions

HIV
Non-HIV
Vagus Nerve Dysfunction

Explore related trials

Autonomic NeuropathyDistal symmetrical polyneuropathyHIV InfectionSmall intestinal bacterial overgrowthVagus Nerve Dysfunction

NCT04353778

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Icahn School of Medicine at Mount Sinai

    New York, New Yorkno site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Jessica Robinson-Papp, MD · PRINCIPAL_INVESTIGATOR · Icahn School of Medicine at Mount Sinai

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Small bowel transit time (SBTT)8 weeks

    Small bowel transit time (SBTT) measured by wireless motility capsule (wmc, smartpill)

  • Gastric pH measurement8 weeks

    Gastric pH measurement measured by wireless motility capsule (wmc, smartpill)

  • Hydrogen/methane breath testing (hbt)8 weeks

    hydrogen/methane breath testing (hbt) to measure small intestinal bacterial overgrowth

  • IL6 measurement [Time Frame: 5 years]8 weeks