Clinical trial NCT04050735: 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
Overall status: COMPLETED
Phase: NA
Conditions: HIV-1-infection
Alcohol Drinking
Keywords: HIV infection
alcohol
brain
inflammation
Lead sponsor: Brown University
Sponsor class: OTHER
Collaborators: name: National Institute of General Medical Sciences (NIGMS)
name: The Miriam Hospital
First posted: 2019-08-08
Enrollment: 76
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Plasma biomarker of microbial translocation
timeFrame: 0-3 hours
measure: Plasma biomarkers of immune activation
timeFrame: 0-3 hours
measure: Cerebral metabolites
timeFrame: 5 hours
measure: White matter diffusivity
timeFrame: 5 hours
Secondary outcomes:
measure: Subjective intoxication
timeFrame: 0-5 hours
measure: Cognitive functioning
timeFrame: 0-2 hours
Other outcomes:
Locations:
city: Providence
country: United States
facility: Brown University and The Miriam Hospital
state: Rhode Island
Study officials:
affiliation: Brown University
name: Mollie Monnig, PhD
role: PRINCIPAL_INVESTIGATOR
References: