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

This study is currently recruiting participants.
Verified July 2013 by Boston Medical Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jeffrey Samet, Boston Medical Center
ClinicalTrials.gov Identifier:
NCT01614626
First received: May 25, 2012
Last updated: July 30, 2013
Last verified: July 2013

May 25, 2012
July 30, 2013
November 2012
September 2015   (final data collection date for primary outcome measure)
Microbial translocation as measured by soluble CD14 (sCD14) [ Time Frame: Participants will be followed for up to 3 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01614626 on ClinicalTrials.gov Archive Site
  • Inflammation/altered coagulation as measured by D-dimer [ Time Frame: Participants will be followed for up to 3 years ] [ Designated as safety issue: No ]
  • Alcohol's association with immunologic aging as measured by flow cytometry [ Time Frame: Participants will be followed for up to 3 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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 (D-dimer); to establish a cohort of HIV-infected Russian drinkers; and to establish a sample repository.

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 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=250) 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 altered coagulation (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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

We are storing serum and plasma for future use, as well as dried blood spots for PEth testing.

Non-Probability Sample

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.

  • HIV Infection
  • Alcohol Use
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
250
August 2016
September 2015   (final data collection date for primary outcome measure)

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
  • Not on ART at the time of enrollment

Exclusion Criteria:

  • Not fluent in Russian
  • Cognitive impairment resulting in inability to provide informed consent
Both
18 Years to 70 Years
No
Contact: Jeffrey Samet, MD, MA, MPH (617)-414-7288 jsamet@bu.edu
Russian Federation
 
NCT01614626
U01AA020780, U01AA020780
Yes
Jeffrey Samet, Boston Medical Center
Boston Medical Center
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Principal Investigator: Jeffrey Samet, MD, MA, MPH Boston Medical Center
Boston Medical Center
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP