Alcohol's Impact on Inflammatory Markers in HIV Disease - Russia ARCH Cohort
Condition: HIV Infection; Alcohol Use
MeSH terms: Alcohol Drinking
Study type: Observational

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.
    

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.
    

Observational model: Cohort
Time perspective: Prospective
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.
      
Biospecimen description: 
      We are storing serum and plasma for future use, as well as dried blood spots for PEth
      testing.
    
Keywords: HIV; Alcohol Use; Microbial Translocation; Inflammation; Altered Coagulation; Russia