Alcohol's Impact on Inflammatory Markers in HIV Disease - Russia ARCH Cohort

Alcohol & Zinc Impact on Inflammatory Markers in HIV Disease - Russia ARCH Cohort

The purpose of this study is to assess the longitudinal association between alcohol consumption and biomarkers of microbial translocation (sCD14) and inflammation/altered coagulation (IL-6/D-dimer); to establish a cohort of HIV-infected Russian drinkers; and to establish a sample repository.

Study Overview

• Status: Completed
• Conditions: HIV Infection; Alcohol Use

Detailed Description

Heavy alcohol consumption in an HIV-infected person may accelerate HIV disease progression and end organ disease with one leading explanatory pathway being via enhanced microbial translocation and inflammation/altered coagulation. Heavy alcohol consumption and HIV infection are both causes of microbial translocation, the process by which bacterial products leak across the gastrointestinal membrane with resultant destructive immune activation. Among HIV-infected people, high levels of microbial translocation (as measured by soluble CD14) and inflammation/altered coagulation (as measured by IL-6 and D-dimer) are each associated with an increased risk of death. Of importance, among HIV-infected persons, heavy drinking is also significantly associated with higher levels of D-dimer in cross-sectional studies. Of note, initiation of antiretroviral therapy (ART) is associated with a reduction in D-dimer levels. Yet the following is not known: is there a longitudinal relationship between alcohol consumption and these biomarkers independent of ART?

Thus, as part of the Uganda, Russia, Boston Alcohol Network for Alcohol Research Collaboration on HIV/AIDS (URBAN ARCH)Consortium, the investigators seek to create the Russia ARCH cohort (n=375) from participants of a recently completed NIAAA-funded randomized controlled trial (RCT) of HIV infected Russian heavy drinkers.

The investigators will be collecting blood from participants at baseline, and at 12- and 24-months post enrollment. In addition to collecting and storing blood samples the investigators will be administering surveys to participants at all 3 timepoints. The investigators will conduct phone interviews with participants at 6- and 18-months post enrollment. The investigators will conduct laboratory tests on the stored samples, including measures of microbial translocation (sCD14) and inflammation/altered coagulation (IL-6/D-dimer) and PEth.

This study will clarify the association between alcohol and key biomarkers over time in HIV-infected heavy drinkers. In addition, the investigators will be collecting and storing blood samples from participants in the study to use for the analyses specified and for future studies looking at HIV-infected heavy drinkers.

• Study Type: Observational
• Enrollment (Actual): 351

Contacts and Locations

Study Locations

• Russian Federation
  • St. Petersburg, Russian Federation
    • Pavlov State Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

This is a study of HIV-infected adults who are ART naive at enrollment. Subjects will be recruited from a recently completed NIAAA trial (HERMITAGE; NCT00483483) and from HIV and addiction care sites.

Description

Inclusion Criteria:

• Age 18-70 years old
• HIV-infected
• Provision of contact information for two contacts to assist with follow-up
• Stable address within St. Petersburg or districts within 100 kilometers of St. Petersburg
• Possession of a home or mobile phone
• ART-naive at the time of enrollment

Exclusion Criteria:

• Not fluent in Russian
• Cognitive impairment resulting in inability to provide informed consent

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Microbial translocation as measured by soluble CD14 (sCD14)	Participants will be followed for up to 3 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Inflammation/altered coagulation as measured by IL-6/D-dimer	Participants will be followed for up to 3 years
Alcohol's association with immunologic aging as measured by flow cytometry	Participants will be followed for up to 3 years

Collaborators and Investigators

• Sponsor: Boston Medical Center
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Investigators: Principal Investigator: Jeffrey Samet, MD, MA, MPH, Boston Medical Center

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2012
• Primary Completion (Actual): April 1, 2018
• Study Completion (Actual): December 15, 2020

Study Registration Dates

• First Submitted: May 25, 2012
• First Submitted That Met QC Criteria: June 6, 2012
• First Posted (Estimate): June 8, 2012

Study Record Updates

• Last Update Posted (Actual): December 17, 2020
• Last Update Submitted That Met QC Criteria: December 16, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Inflammation; HIV; Russia; Alcohol Use; Microbial Translocation; Altered Coagulation
• Additional Relevant MeSH Terms: Drinking Behavior; Alcohol Drinking
• Other Study ID Numbers: H-31200; U01AA020780 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No