Overview

Autonomic Neuropathy, GI Motility, and Inflammation in HIV

Status:
Completed
Trial end date:
2018-06-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Early Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institutes of Health (NIH)
Treatments:
Bromides
Pyridostigmine Bromide
Criteria
Inclusion Criteria:

- ≥18 years old

- Documented evidence of HIV-1 infection

- Stable CART therapy for ≥3 months Most recent HIV-1 viral load ≤100 copies/ml (value
must be within the past six months)

- English speaking

- Able to tolerate autonomic testing (e.g. able to stand, able to perform Valsalva
maneuver).

- If using nicotine-containing products willing to refrain from use for 24 hours prior
to all testing procedures (autonomic reflex screen, breath testing, and gastric
emptying)

- ≥1 GI symptom on the Survey of Autonomic Symptoms (SAS)47

Exclusion Criteria:

- Diagnosis known to cause autonomic dysfunction other than HIV (e.g. Parkinson's
disease, diabetes)

- Diagnosis known to cause GI dysfunction other than HIV (e.g. peptic ulcer disease,
infectious diarrhea)

- Current use of any of the following classes of medications (due to potential for
significant autonomic or GI effects, interaction with pyridostigmine, or interference
with one or more of the testing procedures) Prokinetics (e.g. metoclopramide)
Anti-diarrheals (e.g. loperamide) Antibiotics Mefloquine

- Medical or psychiatric conditions precluding safe participation in study procedures or
deemed likely to result in hospitalization during the study period.

- The presence of one or more of the following diagnoses which render the Valsalva
maneuver relatively or absolutely contraindicated: uncontrolled glaucoma, aortic
stenosis, myocardial infarction in the last 6 months, other retinopathy or unclipped
cerebral aneurysm.

- The presence of one or more of the following diagnoses which impede interpretation of
autonomic testing: cardiac arrhythmias or pacemakers.

- An allergy to eggs (contraindication to gastric emptying scintigraphy)

- Any of the following laboratory results:

Positive pregnancy test (administered to women of childbearing potential only) Urine
toxicology screen positive for stimulants (e.g. amphetamines, cocaine) or opiates/opioids.