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WithdrawnNCT03308331Updated Mar 10, 2020

HIV-1 and Brain Interaction on Smoking Comorbidity

An interventional study of Tobacco smoking and nicotine patch in Smoking, sponsored by University of Maryland, Baltimore. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-10.

Sponsored by University of Maryland, Baltimore · Not applicable, Interventional, and Basic science

Why this study was withdrawn
We originally had a collaboration with a PI but he has left the University.
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read 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 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.

02

Conditions studied

  • Smoking

Keywords

  • HIV
  • nicotine
  • brain
  • smoking
03

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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)
04

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    HIV-1 smokers

    Other: Tobacco smoking and nicotine patch

  • No intervention
    HIV-1 nonsmokers
  • Active comparator
    Healthy control smokers

    Other: Tobacco smoking and nicotine patch

  • No intervention
    Healthy control nonsmokers
  • Active comparator
    HIV-1 nonsmokers using nicotine patch

    Other: Tobacco smoking and nicotine patch

  • No intervention
    HIV-1 nonsmokers using placebo patch
  • Active comparator
    Healthy control nonsmokers using nicotine patch

    Other: Tobacco smoking and nicotine patch

  • No intervention
    Healthy control nonsmokers using placebo patch

Interventions

  • OtherTobacco smoking and nicotine patch

    Tobacco smoking at each participant's regular cigarette. Over-the-counter nicotine patch use

05

What researchers measure

Primary outcomes

  1. Functional and structural connectivity using magnetic resonance imaging (MRI)

    Resting functional MRI and diffusion imaging MRI

    Time frame: one day

Secondary outcomes

  1. HIV-1 reactivation

    HIV-1 viral protein p24 expression

    Time frame: one day

06

Study locations

1 site
  • University of Maryland School of Medicine
    Baltimore, Maryland 21228, United States
07

Registry details

Key details

Study ID
NCT03308331
Lead sponsor
University of Maryland, Baltimore
Responsible party
L. Elliot Hong (MD, University of Maryland, Baltimore) — Principal investigator
First posted
Oct 12, 2017
Start date
Dec 1, 2019 (estimated)
Primary completion
Oct 30, 2025 (estimated)
Completion
Oct 30, 2025 (estimated)
Last update
Mar 10, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is withdrawn, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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