CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 76 enrolled
Drug / intervention
Pyridostigminedrug
Likely dose
Pyridostigmine (dose not specified in protocol)AI-extracted
Key inclusion· 5
  • Age ≥18 years
  • Documented HIV-1 infection
  • Stable antiretroviral therapy for ≥3 months with recent HIV-1 viral load ≤100 copies/ml (within past 6 months)
  • At least one gastrointestinal symptom on the Survey of Autonomic Symptoms (SAS)
Key exclusion· 8
  • Known diagnosis causing autonomic dysfunction other than HIV (e.g., Parkinson's disease, diabetes)
  • Known diagnosis causing GI dysfunction other than HIV (e.g., peptic ulcer disease, infectious diarrhea)
  • Current use of prokinetics, anti-diarrheals, antibiotics, or mefloquine
  • Medical or psychiatric conditions precluding safe study participation or likely to result in hospitalization during study

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02850276
NCT02850276Early Ph 1Completed

Autonomic Neuropathy, Gastrointestinal Motility, and Inflammation in HIV

Icahn School of Medicine at Mount Sinai·interventional·Posted Jul 29, 2016·Updated May 29, 2019

In Brief

A Early Phase 1 clinical trial evaluating Pyridostigmine for HIV Disease. Completed, enrolled 76 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Disease
CountriesUnited States

Timeline

Early Ph 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 29, 2016
Enrollment StartNov 1, 2015
Primary CompletionJun 1, 2018
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 9.9 years ago

Interventions

Pyridostigminedrug