Inflammation Clinical Trial
Official title:
Acute Impact of Switching From Tobacco Cigarettes to E-Cigarettes in People Living With HIV
NCT number | NCT04568395 |
Other study ID # | 20-001179 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 1, 2020 |
Est. completion date | May 8, 2023 |
Verified date | October 2023 |
Source | University of California, Los Angeles |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Randomized controlled trial of acute use of electronic cigarette or tobacco cigarette on parameters of ventricular repolarization and inflammation/oxidative stress.
Status | Completed |
Enrollment | 37 |
Est. completion date | May 8, 2023 |
Est. primary completion date | May 8, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 45 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | UCaliforniaLA | Los Angeles | California |
United States | UCLA | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
University of California, Los Angeles | Tobacco Related Disease Research Program |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Tpe | interval indicative of ventricular repolarization measured on ECG | Change in Tpe 5 minutes after cigarette use | |
Primary | Tpe/QT | interval indicative of ventricular repolarization measured on ECG | Change in Tpe/QT after cigarette use | |
Primary | Tpe/QTc | interval indicative of ventricular repolarization measured on ECG | Change in Tpe/QTc after cigarette use | |
Primary | Total Cellular Reactive Oxygen Stress | total cellular oxidative stress measured by flow cytometry | within 4 hours of cigarette use | |
Secondary | QT | interval indicative of ventricular repolarization measured on ECG | Change in QT after cigarette use | |
Secondary | QTc | interval indicative of ventricular repolarization measured on ECG | Change in QTc after cigarette use |
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