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

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ClinicalTrials.gov Identifier: NCT01614626
Recruitment Status : Completed
First Posted : June 8, 2012
Last Update Posted : December 17, 2020
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Jeffrey Samet, Boston Medical Center

Brief Summary:
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.

Condition or disease
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.

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Study Type : Observational
Actual Enrollment : 351 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Alcohol & Zinc Impact on Inflammatory Markers in HIV Disease - Russia ARCH Cohort
Actual Study Start Date : November 2012
Actual Primary Completion Date : April 2018
Actual Study Completion Date : December 15, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Primary Outcome Measures :
  1. Microbial translocation as measured by soluble CD14 (sCD14) [ Time Frame: Participants will be followed for up to 3 years ]

Secondary Outcome Measures :
  1. Inflammation/altered coagulation as measured by IL-6/D-dimer [ Time Frame: Participants will be followed for up to 3 years ]
  2. Alcohol's association with immunologic aging as measured by flow cytometry [ Time Frame: Participants will be followed for up to 3 years ]

Biospecimen Retention:   Samples With DNA
We are storing serum and plasma for future use, as well as dried blood spots for PEth testing.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01614626

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Russian Federation
Pavlov State Medical University
St. Petersburg, Russian Federation
Sponsors and Collaborators
Boston Medical Center
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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Principal Investigator: Jeffrey Samet, MD, MA, MPH Boston Medical Center
Additional Information:
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Responsible Party: Jeffrey Samet, Chief, Section of General Internal Medicine, Boston Medical Center
ClinicalTrials.gov Identifier: NCT01614626    
Other Study ID Numbers: H-31200
U01AA020780 ( U.S. NIH Grant/Contract )
First Posted: June 8, 2012    Key Record Dates
Last Update Posted: December 17, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jeffrey Samet, Boston Medical Center:
Alcohol Use
Microbial Translocation
Altered Coagulation
Additional relevant MeSH terms:
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Alcohol Drinking
Drinking Behavior