Effects of Vagal Dysfunction on Gastrointestinal and Inflammatory Pathways in HIV

• Status: Recruiting
• Trial end date: 2025-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The study team's prior research has shown that dysfunction of a specific nerve, called the vagus nerve, is associated with small intestinal bacterial overgrowth (SIBO), and that SIBO is associated with signs of inflammation in the blood of people living with HIV (PLWH). This research will explore pathways linking vagal dysfunction to inflammation in HIV, focusing on the gastrointestinal tract, and study whether a medication called pyridostigmine and stimulation of the vagus nerve are beneficial therapies.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Treatments: Pyridostigmine Bromide

Criteria

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.