Alcohol's Impact on Inflammatory Markers in HIV Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

351 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-11-30

Study Completion Date

2020-12-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HIV Infection Alcohol Use

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

HIV Alcohol Use Microbial Translocation Inflammation Altered Coagulation Russia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jeffrey Samet

Chief, Section of General Internal Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jeffrey Samet, MD, MA, MPH

Role: PRINCIPAL_INVESTIGATOR

Boston Medical Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Pavlov State Medical University

Saint Petersburg, , Russia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Russia

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

U01AA020780

Identifier Type: NIH

Identifier Source: secondary_id

View Link

H-31200

Identifier Type: -

Identifier Source: org_study_id

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