Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 31 of 126 for:    "Viral Infectious Disease" | "Ethanol"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04050735
Recruitment Status : Not yet recruiting
First Posted : August 8, 2019
Last Update Posted : August 8, 2019
Sponsor:
Information provided by (Responsible Party):
Brown University

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.

Condition or disease Intervention/treatment Phase
HIV-1-infection Alcohol Drinking Other: Alcohol, ethyl, moderate dose Other: Placebo Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Acute Neural and Immune Effects of Alcohol in People Living With HIV Infection
Estimated Study Start Date : November 1, 2019
Estimated Primary Completion Date : October 31, 2022
Estimated Study Completion Date : October 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Alcohol, ethyl, moderate dose
0.6 gram ethyl alcohol per kilogram of body weight
Other: Alcohol, ethyl, moderate dose
Moderate oral dose of ethyl alcohol

Placebo Comparator: Placebo
0 gram ethyl alcohol per kilogram of body weight
Other: Placebo
Placebo beverage




Primary Outcome Measures :
  1. Plasma biomarker of microbial translocation [ Time Frame: 0-3 hours ]
    Lipopolysaccharide (LPS), measured in pg/ml

  2. Plasma biomarkers of immune activation [ Time Frame: 0-3 hours ]
    LPS binding protein (LBP), soluble cluster of differentiation 14 (sCD14), soluble cluster of differentiation 163 (sCD163), measured in ng/ml

  3. Cerebral metabolites [ Time Frame: 5 hours ]
    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.

  4. White matter diffusivity [ Time Frame: 5 hours ]
    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 :
  1. Subjective intoxication [ Time Frame: 0-5 hours ]
    Visual Analog Scale, where a higher rating indicates greater subjective feelings of alcohol intoxication

  2. Cognitive functioning [ Time Frame: 0-2 hours ]
    Repeatable Battery for Assessment of Neuropsychological Status standardized scores



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 21 to 50 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 in past year showing negative antibody results for Hepatitis B and C
  • HIV-1 serostatus confirmed by Western blot
  • HIV-specific criteria for antiretroviral medication use and lab parameters

Exclusion Criteria:

  • heavy drinking as defined by study protocol
  • treatment for alcohol/drug use, with exception of smoking cessation
  • liver enzymes > 5 times the upper normal limits in past 6 months, or cirrhosis
  • use of specific medications or supplements in the past month
  • daily use of specific over-the-counter drugs
  • disorder of the lower GI tract
  • positive urine drug test, self-reported drug use, 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

Layout table for additonal information
Responsible Party: Brown University
ClinicalTrials.gov Identifier: NCT04050735     History of Changes
Other Study ID Numbers: 1904002429
First Posted: August 8, 2019    Key Record Dates
Last Update Posted: August 8, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Informed Consent Form (ICF)
Time Frame: Individual-level data will be available after papers are accepted for publication.
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.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
RNA Virus Infections
Virus Diseases
Ethanol
Infection
Communicable Diseases
HIV Infections
Alcohol Drinking
Lentivirus Infections
Retroviridae Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Drinking Behavior
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs