NCT04050735

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Brown University · Academic / Other
• Sex: All
• Age: 21 Years – 60 Years
• Healthy volunteers: Accepted

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 people living with HIV 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.

Conditions

• HIV-1-infection
• Alcohol Drinking

Interventions

Type	Name	Description
OTHER	Alcohol, ethyl, moderate dose	Moderate oral dose of ethyl alcohol
OTHER	Placebo	Placebo beverage

Timeline

• Start date: 2021-05-19
• Primary completion: 2024-07-02
• Completion: 2024-07-02
• First posted: 2019-08-08
• Last updated: 2025-12-17
• Results posted: 2025-12-17

Locations

1 site across 1 country: United States