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NCT02850276 · ClinicalTrials.gov registry record · Early Phase 1

Autonomic Neuropathy, GI Motility, and Inflammation in HIV

A Early Phase 1 study, sponsored by Icahn School of Medicine at Mount Sinai.

Completed
Registry status
Early Phase 1
Development phase
76
Enrollment target

NCT02850276: Completed Early Phase 1 study, sponsored by Icahn School of Medicine at Mount Sinai.

NCT02850276 is a Early Phase 1 study that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 76 participants, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (43% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02850276, a Early Phase 1 study, has completed, sponsored by Icahn School of Medicine at Mount Sinai.

COMPLETED
Registry status
Early Phase 1
Development phase
76 participants
Enrollment target

Study Summary

The purpose of this study is to explore a possible link between the autonomic nervous system and immune function in patients with HIV. Sometimes HIV can cause these nerves to function abnormally, this is called HIV-associated autonomic neuropathy (HIV-AN). HIV-AN is a condition that is different from person to person. In some people it causes no symptoms and is not harmful, in others it may cause symptoms such as dizziness or lightheadedness, nausea, vomiting, diarrhea, constipation, or problems urinating. Most people with HIV-AN don't know that they have it. One of the important nerves in the autonomic nervous system is the vagus nerve. Abnormal function of the vagus nerve may cause stomach and intestinal slowing, which could lead to an overgrowth of bacteria. The body senses these bacteria and tries to fight them, leading to inflammation. In this study the researchers will test whether abnormal function of the vagus nerve in HIV is associated with stomach slowing and overgrowth of bacteria, and if a drug called pyridostigmine can help.

Primary Outcome

Breath Test at week 8 as compared to baseline. Breath test results is the rise in the combined hydrogen and methane during the breath test.

Interventions

  • DRUG Pyridostigmine

Trial Details

FieldValue
Enrollment Target 76 participants
Start Date 2015-11
Est. Completion 2018-06-01
Phase Early Phase 1

What the finished NCT02850276 record still lists

NCT02850276 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 76 participants, a relatively small participant target, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (43% higher).

The record links to 0 conditions, and to 1 intervention - of which Pyridostigmine is the first listed.

NCT02850276 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02850276 about?

NCT02850276 is a clinical study titled "Autonomic Neuropathy, GI Motility, and Inflammation in HIV". The purpose of this study is to explore a possible link between the autonomic nervous system and immune function in patients with HIV. Sometimes HIV can cause these nerves to function abnormally, this is called HIV-associated autonomic neuropathy (HIV-AN). HIV-AN is a condition that is different fro...

What is the current status of trial NCT02850276?

This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 76 participants. The study started on 2015-11. Estimated completion is 2018-06-01.

What interventions are being tested in trial NCT02850276?

The interventions under investigation include: Pyridostigmine (DRUG).

Who is sponsoring clinical trial NCT02850276?

This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02850276's enrollment target sits among peer trials

76 303rd of 2000 higher than 1,698 of 2,000 other Early Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02850276, the US trial registry maintained by the National Library of Medicine. NCT02850276 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.