Acute Neural and Immune Effects of Alcohol in People Living With HIV Infection (NCT04050735) | Clinical Trial Compass
CompletedNot Applicable
Acute Neural and Immune Effects of Alcohol in People Living With HIV Infection
United States76 participantsStarted 2021-05-19
Plain-language 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.
Who can participate
Age range21 Years – 60 Years
SexALL
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Inclusion criteria
✓. 21-60 years old;
✓. Able to speak and read English at least at 8th grade level;
✓. Alcohol use ≥.60 g/kg at least once in past year. In standard drinks, this amount translates to 1.9-3.0 drinks for an average-weight female and 2.4-3.9 drinks for an average-weight male.
✓. Body mass index of 18.5-34.9 kg/m2;
✓. Lab tests obtained in past year showing no evidence of acute/chronic Hepatitis B or C infection;
✓. HIV-1 serostatus (positive or negative, depending on group) confirmed by standard clinical testing;
✓. Able to consume soy and nuts safely (in order to consume the standardized meal).
Exclusion criteria
✕. History of heavy drinking on a weekly or more frequent basis, with heavy drinking defined per NIAAA guidelines (≥4 drinks for women, ≥5 drinks for men on a given day), in the past two years;
✕. More than five heavy drinking episodes in past 90 days;
✕. Seeking or receiving treatment for alcohol/drug use, with exception of smoking cessation treatment;
✕. Antibiotic use in past 1 month;
✕. Daily use of non-steroidal anti-inflammatory drugs, which are known to increase gut permeability;
✕. Disorder of the lower GI tract (e.g., inflammatory bowel disease, ulcerative colitis);
✕. Positive urine test for amphetamine, cocaine, methamphetamine, opioids, or benzodiazepines (cannabis use will be assessed but is not an exclusion criterion);
✕. Positive screening for past 12-month drug use disorder, indicated by Drug Abuse Screening Test-10 score \>2;