NCT04353778 Effects of Vagal Dysfunction on Gastrointestinal and Inflammatory Pathways in HIV
| NCT ID | NCT04353778 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Icahn School of Medicine at Mount Sinai |
| Condition | HIV |
| Study Type | INTERVENTIONAL |
| Enrollment | 207 participants |
| Start Date | 2020-08-03 |
| Primary Completion | 2026-09-16 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 207 participants in total. It began in 2020-08-03 with a primary completion date of 2026-09-16.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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.
Contact & Investigator
Niyati Neupane
✉ niyati.neupane@mssm.eduJessica Robinson-Papp, MD
PRINCIPAL INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Frequently Asked Questions
Who can join the NCT04353778 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying HIV. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04353778 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04353778 currently recruiting?
Yes, NCT04353778 is actively recruiting participants. Contact the research team at niyati.neupane@mssm.edu for enrollment information.
Where is the NCT04353778 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT04353778 clinical trial?
NCT04353778 is sponsored by Icahn School of Medicine at Mount Sinai. The principal investigator is Jessica Robinson-Papp, MD at Icahn School of Medicine at Mount Sinai. The trial plans to enroll 207 participants.
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