Phase 2 HIV and AIDS Trial, Recruiting NCT04353778 Sponsor: Icahn School of Medicine at Mount Sinai Condition: HIV and AIDS
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Phase 2 HIV and AIDS Trial, Recruiting

NCT04353778
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Adults aged 18 or older
  • People who have a confirmed diagnosis of HIV-1 infection
  • People who have been on a stable HIV treatment regimen for at least 3 months
  • People whose HIV-1 viral load has been below 100 copies/ml within the past 3 months
  • People who do not have any other known condition that affects the nervous system's automatic functions or the digestive system (such as Parkinson's disease, diabetes, peptic ulcer disease, or infectious diarrhoea)
  • People who are willing to avoid nicotine products for 24 hours before each testing session
  • People who are not taking medications that significantly affect the nervous system's automatic functions or the digestive system (such as stimulant medications, gut-motility drugs, anti-diarrhoeal medications, or antibiotics)
  • People whose urine test comes back negative for stimulants and opioids, and who test negative for pregnancy if applicable

Who may not be able to join:

  • People who have difficulty swallowing food or pills
  • People with a known or suspected blockage anywhere in the digestive tract (such as strictures, fistulas, or similar conditions)
  • People who have had digestive system surgery within the past 3 months, or who have Crohn's disease, diverticulitis, or an implanted electrical or mechanical medical device such as a pacemaker or infusion pump
  • People who have a medical reason why they cannot take the study drug pyridostigmine — for example, a bowel or urinary blockage, an allergy to pyridostigmine, heart rhythm problems, asthma, or chronic obstructive pulmonary disease — or who have used pyridostigmine within the past 6 months
  • People with a history of a brain aneurysm or brain bleed, a brain tumour, unusual neck anatomy, or metal implants or hardware near the area where nerve stimulation would be applied, or who have received vagus nerve stimulation (VNS) within the past 6 months
  • People who have no contraindication to autonomic testing — for example, those with uncontrolled glaucoma or a heart rate not under normal sinus rhythm control may not be eligible (confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 23 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

GP referral letter

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Trial details

Status
Recruiting
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
3 August 2020
Est. completion
16 September 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Small bowel transit time (SBTT); Gastric pH measurement; Hydrogen/methane breath testing (hbt); IL6 measurement [Time Frame: 5 years]

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 23 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov