Status:
WITHDRAWN
HIV-1 and Brain Interaction on Smoking Comorbidity
Lead Sponsor:
University of Maryland, Baltimore
Conditions:
Smoking
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
People living with HIV-1 have high rates of cigarette smoking, which may be related to nicotinic interaction with HIV-1 infection and brain function levels. The proposed project aims to understand the...
Detailed Description
Smoking remains the leading cause of preventable morbidity and mortality in the United States. The alarmingly high smoking rates and unsatisfactory performance of standard smoking cessation efforts in...
Eligibility Criteria
Inclusion
- Subjects between ages 18-60 in good health
- Ability to give written informed consent
- For people living with HIV: should be diagnosed with HIV two years or more and on ART two years or more
- For people living with HIV: should have achieved virologic suppression (defined as viral loads of ≤ 200 copies/ml), and without current signs of reactivation
Exclusion
- Inability to sign informed consent
- Unable to undergo MRI scanning due to metallic devices or objects (cardiac pacemaker or neurostimulator, some artificial joints, metal pins, surgical clips or other implanted metal parts) or claustrophobic to the scanner
- Any major medical illnesses to include, but not limited to, uncontrolled high blood pressure or high blood sugar, cardiovascular disease, asthma, peripheral vascular diseases, coagulopathies, history of superficial or deep vein thrombosis as per medical history
- Current substance-induced psychiatric disorders
- Significant alcohol or other drug use, other than nicotine dependence or marijuana use
- Gross structural abnormalities and/or have a history of syncope
- Positive urine pregnancy tests
- Any neurological illnesses to include, but not limited to, seizure disorders, multiple sclerosis, movement disorders, or history of head trauma, CVA, CNS tumor,
- For people living with HIV: having AIDS or non-AIDS-defining cancer or active CNS and other opportunistic disease
- For people living with HIV: on active treatment of hepatitis C virus (HCV)
Key Trial Info
Start Date :
December 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03308331
Start Date
December 1 2019
End Date
October 30 2025
Last Update
March 10 2020
Active Locations (1)
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1
University of Maryland School of Medicine
Baltimore, Maryland, United States, 21228