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Acute Neural and Immune Effects of Alcohol in People Living With HIV Infection

Primary Purpose

HIV-1-infection, Alcohol Drinking

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Alcohol, ethyl, moderate dose
Placebo
Sponsored by
Brown University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for HIV-1-infection focused on measuring HIV infection, alcohol, brain, inflammation

Eligibility Criteria

21 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 21 to 60 years of age
  • able to speak and read English at least at 8th grade level
  • alcohol use as defined by study protocol
  • body mass index of 18.5-30 kg/m2
  • Lab tests obtained in past year showing no evidence of acute/chronic Hepatitis B or C infection
  • HIV-1 serostatus confirmed by standard clinical testing
  • HIV-specific criteria for antiretroviral medication use and lab parameters
  • Able to consume soy and nuts safely

Exclusion Criteria:

  • heavy drinking as defined by study protocol
  • treatment for alcohol/drug use, with exception of smoking cessation
  • use of specific medications in the past month
  • daily use of specific over-the-counter drugs
  • disorder of the lower GI tract
  • positive urine drug test or screening for drug use disorder
  • current major psychiatric disorder
  • history of significant problems from blood draw
  • safety contraindication for MRI
  • head trauma with loss of consciousness > 10 min
  • inability to abstain from nicotine during study session
  • inability to abstain from cannabis before and during study session
  • pregnant, breastfeeding, or not using effective birth control
  • any other clinical condition or therapy that, in the physician's opinion, would make the individual unsuitable for study or unable to comply with dosing requirement

Sites / Locations

  • Brown University and The Miriam HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Alcohol, ethyl, moderate dose

Placebo

Arm Description

0.6 gram ethyl alcohol per kilogram of body weight

0 gram ethyl alcohol per kilogram of body weight

Outcomes

Primary Outcome Measures

Plasma biomarker of microbial translocation
Lipopolysaccharide (LPS), measured in pg/ml
Plasma biomarkers of immune activation
LPS binding protein (LBP), soluble cluster of differentiation 14 (sCD14), soluble cluster of differentiation 163 (sCD163), measured in ng/ml
Cerebral metabolites
Magnetic resonance spectroscopy will be used quantify cerebral metabolites in brain regions of interest. Primary metabolites of interest include the summed peak of glutamate and glutamine; glutathione; and choline.
White matter diffusivity
Diffusion-weighted MRI will be used to quantify diffusivity metrics in brain white matter. Primary outcomes are fractional anisotropy (measured on a scale of 0-1, where 1 reflects total anisotropy), axial diffusivity (parallel to the primary axis), radial diffusivity (perpendicular to the primary axis).

Secondary Outcome Measures

Subjective intoxication
Visual Analog Scale, where a higher rating indicates greater subjective feelings of alcohol intoxication
Cognitive functioning
Repeatable Battery for Assessment of Neuropsychological Status standardized scores

Full Information

First Posted
July 9, 2019
Last Updated
March 7, 2023
Sponsor
Brown University
Collaborators
National Institute of General Medical Sciences (NIGMS), The Miriam Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04050735
Brief Title
Acute Neural and Immune Effects of Alcohol in People Living With HIV Infection
Official Title
Acute Neural and Immune Effects of Alcohol in People Living With HIV Infection
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 19, 2021 (Actual)
Primary Completion Date
July 31, 2023 (Anticipated)
Study Completion Date
July 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Brown University
Collaborators
National Institute of General Medical Sciences (NIGMS), The Miriam Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will examine whether moderate alcohol use in the context of HIV infection exacerbates inflammatory signaling in the immune system and brain. The study will recruit healthy individuals and people living with HIV infection who are otherwise in good health to participate. Participants will complete an experimental protocol that involves controlled alcohol administration and magnetic resonance imaging (MRI). Primary outcomes are plasma biomarkers of inflammation and MRI markers correlated with neuroinflammation. Results will advance understanding of the effects of alcohol use in people living with HIV infection.
Detailed Description
A sample of 56 participants, to include equal numbers of PLWH and uninfected controls, will be recruited to complete the experimental protocol. Participants will be randomized to one of the two beverage conditions (0.60 g/kg alcohol beverage, 0.00 g/kg placebo beverage). Blood samples will be collected at baseline (prior to beverage administration) and for three hours afterward. Cognitive performance and subjective intoxication will be assessed using standardized measures. MRI scans will be collected 4-5 hours after beverage consumption to capture neurobiological outcomes on the descending limb of blood alcohol.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV-1-infection, Alcohol Drinking
Keywords
HIV infection, alcohol, brain, inflammation

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Alcohol, ethyl, moderate dose
Arm Type
Experimental
Arm Description
0.6 gram ethyl alcohol per kilogram of body weight
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
0 gram ethyl alcohol per kilogram of body weight
Intervention Type
Other
Intervention Name(s)
Alcohol, ethyl, moderate dose
Intervention Description
Moderate oral dose of ethyl alcohol
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo beverage
Primary Outcome Measure Information:
Title
Plasma biomarker of microbial translocation
Description
Lipopolysaccharide (LPS), measured in pg/ml
Time Frame
0-3 hours
Title
Plasma biomarkers of immune activation
Description
LPS binding protein (LBP), soluble cluster of differentiation 14 (sCD14), soluble cluster of differentiation 163 (sCD163), measured in ng/ml
Time Frame
0-3 hours
Title
Cerebral metabolites
Description
Magnetic resonance spectroscopy will be used quantify cerebral metabolites in brain regions of interest. Primary metabolites of interest include the summed peak of glutamate and glutamine; glutathione; and choline.
Time Frame
5 hours
Title
White matter diffusivity
Description
Diffusion-weighted MRI will be used to quantify diffusivity metrics in brain white matter. Primary outcomes are fractional anisotropy (measured on a scale of 0-1, where 1 reflects total anisotropy), axial diffusivity (parallel to the primary axis), radial diffusivity (perpendicular to the primary axis).
Time Frame
5 hours
Secondary Outcome Measure Information:
Title
Subjective intoxication
Description
Visual Analog Scale, where a higher rating indicates greater subjective feelings of alcohol intoxication
Time Frame
0-5 hours
Title
Cognitive functioning
Description
Repeatable Battery for Assessment of Neuropsychological Status standardized scores
Time Frame
0-2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 21 to 60 years of age able to speak and read English at least at 8th grade level alcohol use as defined by study protocol body mass index of 18.5-30 kg/m2 Lab tests obtained in past year showing no evidence of acute/chronic Hepatitis B or C infection HIV-1 serostatus confirmed by standard clinical testing HIV-specific criteria for antiretroviral medication use and lab parameters Able to consume soy and nuts safely Exclusion Criteria: heavy drinking as defined by study protocol treatment for alcohol/drug use, with exception of smoking cessation use of specific medications in the past month daily use of specific over-the-counter drugs disorder of the lower GI tract positive urine drug test or screening for drug use disorder current major psychiatric disorder history of significant problems from blood draw safety contraindication for MRI head trauma with loss of consciousness > 10 min inability to abstain from nicotine during study session inability to abstain from cannabis before and during study session pregnant, breastfeeding, or not using effective birth control any other clinical condition or therapy that, in the physician's opinion, would make the individual unsuitable for study or unable to comply with dosing requirement
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Research Assistant
Phone
4018636679
Email
idresearch@lifespan.org
First Name & Middle Initial & Last Name or Official Title & Degree
Principal Investigator
Phone
401-863-3491
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mollie Monnig, PhD
Organizational Affiliation
Brown University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brown University and The Miriam Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02912
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mollie Monnig, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data generated by this study will be made available to outside investigators in accordance with NIH guidance and policies on data sharing. Data will be available in summary form and as raw individual-level data for analysis.
IPD Sharing Time Frame
Individual-level data will be available after papers are accepted for publication.
IPD Sharing Access Criteria
Institutions and individuals wishing to access data must contact the Principal Investigator (Peter Monti, PhD). Persons requesting data must do so in writing, identifying the affiliation and how the data will be used. Co-authorship is not required as a condition for receiving data. Users will agree that the recipient must not transfer the data to other users and that the data are only to be used for research purposes. Requestors will be required to sign a data and biospecimen sharing agreement with further stipulations for data use and security.

Learn more about this trial

Acute Neural and Immune Effects of Alcohol in People Living With HIV Infection

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