NCT03308331

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 7, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 12, 2017

Completed
2.1 years until next milestone

Study Start

First participant enrolled

December 1, 2019

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2025

Completed
Last Updated

March 10, 2020

Status Verified

March 1, 2020

Enrollment Period

5.9 years

First QC Date

October 7, 2017

Last Update Submit

March 6, 2020

Conditions

Smoking

Keywords

HIVnicotinebrainsmoking

Outcome Measures

Primary Outcomes (1)

  • Functional and structural connectivity using magnetic resonance imaging (MRI)

    Resting functional MRI and diffusion imaging MRI

    one day

Secondary Outcomes (1)

  • HIV-1 reactivation

    one day

Study Arms (8)

HIV-1 smokers

EXPERIMENTAL
Other: Tobacco smoking and nicotine patch

HIV-1 nonsmokers

NO INTERVENTION

Healthy control smokers

ACTIVE COMPARATOR
Other: Tobacco smoking and nicotine patch

Healthy control nonsmokers

NO INTERVENTION

HIV-1 nonsmokers using nicotine patch

ACTIVE COMPARATOR
Other: Tobacco smoking and nicotine patch

HIV-1 nonsmokers using placebo patch

NO INTERVENTION

Healthy control nonsmokers using nicotine patch

ACTIVE COMPARATOR
Other: Tobacco smoking and nicotine patch

Healthy control nonsmokers using placebo patch

NO INTERVENTION

Interventions

Tobacco smoking and nicotine patchOTHER

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

HIV-1 nonsmokers using nicotine patchHIV-1 smokersHealthy control nonsmokers using nicotine patchHealthy control smokers

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Maryland School of Medicine

Baltimore, Maryland, 21228, United States

Location

MeSH Terms

Conditions

Smoking

Interventions

Smoking DevicesTobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Manufactured MaterialsTechnology, Industry, and AgricultureTherapeutics
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

October 7, 2017

First Posted

October 12, 2017

Study Start

December 1, 2019

Primary Completion

October 30, 2025

Study Completion

October 30, 2025

Last Updated

March 10, 2020

Record last verified: 2020-03

Locations

US(1)