This trial will study whether a medication and nerve stimulation can help treat inflammation in people with HIV.
- Vagus Nerve Dysfunction
- Non-HIV Related Immunodeficiency
4 Primary · 0 Secondary · Reporting Duration: 5 years
4 Treatment Groups
1 of 4
1 of 4
1 of 4
1 of 4
150 Total Participants · 4 Treatment Groups
Primary Treatment: Pyridostigmine · Has Placebo Group · Phase 1 & 2
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Age 18+ · All Participants · 9 Total Inclusion CriteriaMark “Yes” if the following statements are true for you:
- Robinson-Papp, Jessica, Alexandra Nmashie, Elizabeth Pedowitz, Mary Catherine George, Sandeep Sharma, Jacinta Murray, Emma K T Benn, et al.. 2019. “The Effect of Pyridostigmine on Small Intestinal Bacterial Overgrowth (SIBO) and Plasma Inflammatory Biomarkers in Hiv-associated Autonomic Neuropathies”. Journal of Neurovirology. Springer Science and Business Media LLC. doi:10.1007/s13365-019-00756-9.
- Tarn, Jessica, Sarah Legg, Sheryl Mitchell, Bruce Simon, and Wan-Fai Ng. 2019. “The Effects of Noninvasive Vagus Nerve Stimulation on Fatigue and Immune Responses in Patients with Primary Sjögren’s Syndrome”. Neuromodulation: Technology at the Neural Interface. Elsevier BV. doi:10.1111/ner.12879.
- Lerman, Imanuel, Richard Hauger, Linda Sorkin, James Proudfoot, Bryan Davis, Andy Huang, Katie Lam, Bruce Simon, and Dewleen G. Baker. 2016. “Noninvasive Transcutaneous Vagus Nerve Stimulation Decreases Whole Blood Culture-derived Cytokines and Chemokines: A Randomized, Blinded, Healthy Control Pilot Trial”. Neuromodulation: Technology at the Neural Interface. Elsevier BV. doi:10.1111/ner.12398.
- Carod-Artal, Francisco Javier. 2017. “Infectious Diseases Causing Autonomic Dysfunction”. Clinical Autonomic Research. Springer Science and Business Media LLC. doi:10.1007/s10286-017-0452-4.
- Robinson-Papp, Jessica, Alexandra Nmashie, Elizabeth Pedowitz, Emma K.T. Benn, Mary Catherine George, Sandeep Sharma, Jacinta Murray, et al.. 2018. “Vagal Dysfunction and Small Intestinal Bacterial Overgrowth”. Aids. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/qad.0000000000001802.
- Paulon, Emma, Despoina Nastou, Francesca Jaboli, Juana Marin, Eric Liebler, and Owen Epstein. 2017. “Proof of Concept: Short-term Non-invasive Cervical Vagus Nerve Stimulation in Patients with Drug-refractory Gastroparesis”. Frontline Gastroenterology. BMJ. doi:10.1136/flgastro-2017-100809.
- Carod-Artal FJ. Infectious diseases causing autonomic dysfunction. Clin Auton Res. 2018 Feb;28(1):67-81. doi: 10.1007/s10286-017-0452-4. Epub 2017 Jul 20.
- Tarn J, Legg S, Mitchell S, Simon B, Ng WF. The Effects of Noninvasive Vagus Nerve Stimulation on Fatigue and Immune Responses in Patients With Primary Sjogren's Syndrome. Neuromodulation. 2019 Jul;22(5):580-585. doi: 10.1111/ner.12879. Epub 2018 Oct 17.
- Jessica Robinson-Papp 2020. "Effects of Vagal Dysfunction on Gastrointestinal and Inflammatory Pathways in HIV". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04353778.
Frequently Asked Questions
In what situations is Pyridostigmine generally utilized?
"Pyridostigmine is used to manage symptoms of myasthenia gravis, dyschezia, orthostatic syncope, and non-depolarizing neuromuscular blocking agents." - Anonymous Online Contributor
Could you share the aggregate figure of participants enrolled in this research endeavor?
"Indeed, clinicaltrials.gov attests that this research project is actively recruiting participants. This trial was published on August 3rd 2020 and has since been modified on April 12th 2022. The study necessitates 250 test subjects from a single medical site." - Anonymous Online Contributor
Is enrollment for this experiment currently available to participants?
"Affirmative. According to information hosted on clinicaltrials.gov, this study is presently seeking participants--the trial was first published on August 3rd 2020 and the most recent update occurred on April 12th 2022. The experiment has allocated 250 slots across one medical site." - Anonymous Online Contributor
Are there pre-existing studies that utilize Pyridostigmine?
"At present, 4 clinical trials investigating the effects of Pyridostigmine are being conducted. Unfortunately, none of these investigations have advanced to Phase 3. Nevertheless, individuals in Nashville, Tennessee and its surrounding areas can access numerous research sites that offer this medical intervention." - Anonymous Online Contributor