Medication + Nerve Stimulation for HIV
(EVA Trial)
Trial Summary
What is the purpose of this trial?
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.
Do I have to stop taking my current medications for the trial?
The trial requires that you do not take medications with significant autonomic or GI effects, such as sympathomimetics, prokinetics, anti-diarrheals, and antibiotics. If you are on these medications, you may need to stop them to participate.
Do I have to stop taking my current medications for the trial?
The trial requires that you do not take medications with significant effects on the autonomic or gastrointestinal systems, such as certain stimulants, antibiotics, or anti-diarrheals. If you are on such medications, you may need to stop them to participate.
What data supports the idea that Medication + Nerve Stimulation for HIV is an effective treatment?
The available research shows that non-invasive vagus nerve stimulation (VNS) has been explored for its potential benefits in various conditions, such as epilepsy, depression, and intellectual disabilities. However, there is no specific data provided here that directly supports the effectiveness of Medication + Nerve Stimulation for HIV. The studies mention potential benefits in other areas, but more research is needed to determine its effectiveness for HIV treatment.12345
What data supports the effectiveness of this treatment for HIV?
Transcutaneous vagus nerve stimulation (tVNS) is a non-invasive technique that has shown promise in treating conditions like epilepsy and depression by potentially increasing norepinephrine activity in the brain. While specific data on its effectiveness for HIV is not available, its use in other conditions suggests it may have beneficial effects on the nervous system.12345
What safety data exists for Medication + Nerve Stimulation for HIV?
The safety data for non-invasive vagus nerve stimulation (nVNS) and transcutaneous vagus nerve stimulation (tVNS) indicates that these techniques are generally safe and well-tolerated. The PRESTO trial showed nVNS to be safe for treating migraines. A systematic review and meta-analysis of transcutaneous auricular vagus nerve stimulation (taVNS) found it to be safe with mild and transient adverse effects like ear pain, headache, and tingling. No severe adverse events were causally linked to taVNS, and the incidence of adverse events was low. These findings suggest that nerve stimulation techniques are safe for clinical use.15678
Is transcutaneous vagus nerve stimulation (tVNS) safe for humans?
Transcutaneous vagus nerve stimulation (tVNS) is generally considered safe, with mild and temporary side effects like ear pain, headache, and tingling. A systematic review found no significant difference in the risk of adverse events between active tVNS and control groups, and no severe adverse events were linked to tVNS.15678
Is the treatment Non-invasive Vagal Nerve Stimulation, Pyridostigmine a promising treatment for HIV?
Yes, Non-invasive Vagal Nerve Stimulation (tVNS) is a promising treatment because it is a new, non-invasive method that can be used to help manage various health conditions. It is safe, inexpensive, and portable, making it accessible for many people. It has shown positive effects in treating conditions like epilepsy and depression, which suggests it could be beneficial for other diseases like HIV.14579
How is the treatment of non-invasive vagal nerve stimulation and pyridostigmine for HIV different from other treatments?
This treatment is unique because it combines a non-invasive technique called transcutaneous vagus nerve stimulation (tVNS) with the drug pyridostigmine. Unlike traditional treatments that may involve surgery or more invasive methods, tVNS is a safe, portable, and inexpensive way to stimulate the vagus nerve, potentially improving central and peripheral health without the need for surgical implantation.14579
Research Team
Jessica Robinson-Papp, MD
Principal Investigator
Icahn School of Medicine at Mount Sinai
Eligibility Criteria
This trial is for adults with HIV who have a stable treatment regimen, no drug use or pregnancy, and no other conditions affecting the nervous system or gastrointestinal tract. Participants must not smoke for 24 hours before tests and can't be on certain medications that affect the autonomic system or digestion.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Participants undergo autonomic function tests, hydrogen/methane breath testing, Wireless Motility Capsule testing, blood draw, and collection of stool samples and oral swabs
Treatment
Participants receive 8 weeks of pyridostigmine or placebo, or undergo 8 weeks of non-invasive vagal nerve stimulation
Follow-up
Participants are retested for autonomic function, hydrogen/methane breath testing, Wireless Motility Capsule testing, blood draw, and collection of stool samples and oral swabs
Treatment Details
Interventions
- Non-invasive Vagal Nerve Stimulation
- Placebos
- Pyridostigmine
Non-invasive Vagal Nerve Stimulation is already approved in United States, European Union for the following indications:
- Cluster headache
- Migraine
- Cluster headache
- Migraine
- Hemicrania continua
Find a Clinic Near You
Who Is Running the Clinical Trial?
Icahn School of Medicine at Mount Sinai
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator