HIV-1 and Brain Interaction on Smoking Comorbidity

Not Applicable

Withdrawn

• Conditions: Smoking
• Interventions: Other: Tobacco smoking and nicotine patch

• Registration Number: NCT03308331
• Lead Sponsor: University of Maryland, Baltimore

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 these pathways using translational brain imaging and HIV-1 reactivation studies. The study proposes a targeted nicotine-brain investigation of the nicotinic effects in HIV-1 infection from cellular to brain circuitry levels.

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 people living with HIV/AIDS (PLWH) interfere with the overall progress in the treatment of HIV-1 infection. Our understanding of nicotine addiction mechanisms in PLWH, and how they are related to and interact with HIV-1 neuropathology, is limited and thus hindering the development of more effective, targeted treatments. The study will directly address neurological complication of this HIV-associated comorbidity at the brain circuitry level using state-of-the-art imaging tools and methods.

Study Timeline

• Study First Submitted: 2017-10-07
• Study First Submitted QC: 2017-10-07
• Study First Posted: 2017-10-12
• Study Start: 2019-12-01
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-06
• Last Update Posted: 2020-03-10
• Primary Completion: 2025-10-30
• Study Completion: 2025-10-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Subjects between ages 18-60 in good health
2. Ability to give written informed consent
3. For people living with HIV: should be diagnosed with HIV two years or more and on ART two years or more
4. For people living with HIV: should have achieved virologic suppression (defined as viral loads of ≤ 200 copies/ml), and without current signs of reactivation

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Exclusion Criteria

1. Inability to sign informed consent
2. 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
3. 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
4. Current substance-induced psychiatric disorders
5. Significant alcohol or other drug use, other than nicotine dependence or marijuana use
6. Gross structural abnormalities and/or have a history of syncope
7. Positive urine pregnancy tests
8. Any neurological illnesses to include, but not limited to, seizure disorders, multiple sclerosis, movement disorders, or history of head trauma, CVA, CNS tumor,
9. For people living with HIV: having AIDS or non-AIDS-defining cancer or active CNS and other opportunistic disease
10. For people living with HIV: on active treatment of hepatitis C virus (HCV)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy control smokers	Tobacco smoking and nicotine patch	-
Healthy control nonsmokers using nicotine patch	Tobacco smoking and nicotine patch	-
HIV-1 smokers	Tobacco smoking and nicotine patch	-
HIV-1 nonsmokers using nicotine patch	Tobacco smoking and nicotine patch	-

Primary Outcome Measures

Name	Time	Method
Functional and structural connectivity using magnetic resonance imaging (MRI)	one day	Resting functional MRI and diffusion imaging MRI

Secondary Outcome Measures

Name	Time	Method
HIV-1 reactivation	one day	HIV-1 viral protein p24 expression

Trial Locations

Locations (1)

University of Maryland School of Medicine; 🇺🇸 Baltimore, Maryland, United States