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HIV-1 and Brain Interaction on Smoking Comorbidity

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ClinicalTrials.gov Identifier: NCT03308331
Recruitment Status : Not yet recruiting
First Posted : October 12, 2017
Last Update Posted : September 21, 2018
Sponsor:
Information provided by (Responsible Party):
L. Elliot Hong, University of Maryland

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.

Condition or disease Intervention/treatment Phase
Smoking Other: Tobacco smoking and nicotine patch Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: HIV-1 and Brain Interaction on Smoking Comorbidity
Estimated Study Start Date : October 1, 2018
Estimated Primary Completion Date : October 30, 2025
Estimated Study Completion Date : October 30, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: HIV-1 smokers Other: Tobacco smoking and nicotine patch
Tobacco smoking at each participant's regular cigarette. Over-the-counter nicotine patch use

No Intervention: HIV-1 nonsmokers
Active Comparator: Healthy control smokers Other: Tobacco smoking and nicotine patch
Tobacco smoking at each participant's regular cigarette. Over-the-counter nicotine patch use

No Intervention: Healthy control nonsmokers
Active Comparator: HIV-1 nonsmokers using nicotine patch Other: Tobacco smoking and nicotine patch
Tobacco smoking at each participant's regular cigarette. Over-the-counter nicotine patch use

No Intervention: HIV-1 nonsmokers using placebo patch
Active Comparator: Healthy control nonsmokers using nicotine patch Other: Tobacco smoking and nicotine patch
Tobacco smoking at each participant's regular cigarette. Over-the-counter nicotine patch use

No Intervention: Healthy control nonsmokers using placebo patch



Primary Outcome Measures :
  1. Functional and structural connectivity using magnetic resonance imaging (MRI) [ Time Frame: one day ]
    Resting functional MRI and diffusion imaging MRI


Secondary Outcome Measures :
  1. HIV-1 reactivation [ Time Frame: one day ]
    HIV-1 viral protein p24 expression



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03308331


Contacts
Contact: Dawn Detamore 4104026820 ddetamor@mprc.umaryland.edu
Contact: Elliot Hong, MD 4104026828 ehong@mprc.umaryland.edu

Locations
United States, Maryland
University of Maryland School of Medicine Not yet recruiting
Baltimore, Maryland, United States, 21228
Contact: Dawn Detamore    410-402-6820    ddetamor@mprc.umaryland.edu   
Sponsors and Collaborators
University of Maryland

Responsible Party: L. Elliot Hong, MD, University of Maryland
ClinicalTrials.gov Identifier: NCT03308331     History of Changes
Other Study ID Numbers: HP-00075780
First Posted: October 12, 2017    Key Record Dates
Last Update Posted: September 21, 2018
Last Verified: September 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by L. Elliot Hong, University of Maryland:
HIV
nicotine
brain
smoking

Additional relevant MeSH terms:
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action