Effects of Vagal Dysfunction on Gastrointestinal and Inflammatory Pathways in HIV

Launched by ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · Apr 17, 2020

Keywords

ClinConnect Summary

This clinical trial is investigating how problems with the vagus nerve, which plays a key role in gut health and inflammation, might affect people living with HIV. Researchers have found that issues with this nerve can lead to a condition called small intestinal bacterial overgrowth (SIBO), which is linked to increased inflammation in the body. The study aims to explore how these connections work and whether treatments like a medication called pyridostigmine and vagus nerve stimulation can help improve health outcomes for individuals with HIV.

To participate in this trial, individuals must be at least 18 years old and have a documented HIV-1 infection, while also being on stable antiretroviral treatment for at least three months. Other important criteria include having a low viral load and no other conditions that significantly affect gut function. Participants can expect to undergo various tests related to their gastrointestinal health and may receive the study treatments. It’s important to note that those with certain gastrointestinal issues or who have recently had specific surgeries may not be eligible for this study. Overall, this trial seeks to better understand and potentially improve gastrointestinal health in people living with HIV.

Gender

ALL

Eligibility 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.