Acute Effects of TCIG vs ECIG in PLWH

Study Overview
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Brief Summary
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Randomized controlled trial of acute use of electronic cigarette or tobacco cigarette on parameters of ventricular repolarization and inflammation/oxidative stress.

Detailed Description
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On separate days, participants will undergo 3 different exposures: an acute e-cigarette exposure, an acute tobacco cigarette exposure, and a sham (empty e-cigarette) control . Before and after the acute exposure, participants will have blood drawn for inflammation/oxidative stress markers and undergo a 5-minute ECG recording.

Official Title
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Acute Impact of Switching From Tobacco Cigarettes to E-Cigarettes in People Living With HIV

Conditions
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HIV I Infection, E Cigarette Use, Vaping, Smoking, Tobacco Smoking, Nicotine Use Disorder, Qt Interval, Variation in, Oxidative Stress, Inflammation

Intervention / Treatment
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* Other: TCIG
* Other: ECIG
* Other: sham control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronic (> 1year) TCIG smoker HIV positive Stable ART Viral count non-detectable CD4 >500 Exclusion Criteria: Known major illness (heart disease, diabetes, lung or liver disease) Daily recreational drug use, including cannabis >2 alcoholic drinks per day Obesity (>30 kg/m2) Recent (<3 months) infection

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Interventional Model Description: Crossover with 1 week washout
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PLWH smoker<br>PLWH who smoke will undergo 3 interventions : acute TCIG use, acute ECIG use and acute sham control | Other: TCIG<br>* Use a TCIG<br>Other: ECIG<br>* Use an ECIG<br>Other: sham control<br>* Use a sham control (empty ECIG)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tpe | interval indicative of ventricular repolarization measured on ECG | Change in Tpe 5 minutes after cigarette use | 
| Tpe/QT | interval indicative of ventricular repolarization measured on ECG | Change in Tpe/QT after cigarette use | 
| Tpe/QTc | interval indicative of ventricular repolarization measured on ECG | Change in Tpe/QTc after cigarette use | 
| Total Cellular Reactive Oxygen Stress | total cellular oxidative stress measured by flow cytometry | within 4 hours of cigarette use | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QT | interval indicative of ventricular repolarization measured on ECG | Change in QT after cigarette use | 
| QTc | interval indicative of ventricular repolarization measured on ECG | Change in QTc after cigarette use |