This trial is active, not recruiting.

Conditions hiv infection, alcohol use
Sponsor Boston Medical Center
Collaborator National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Start date November 2012
End date October 2017
Trial size 375 participants
Trial identifier NCT01614626, U01AA020780


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Microbial translocation as measured by soluble CD14 (sCD14)
time frame: Participants will be followed for up to 3 years

Secondary Outcomes

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

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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

Additional Information

Official title Alcohol & Zinc Impact on Inflammatory Markers in HIV Disease - Russia ARCH Cohort
Principal investigator Jeffrey Samet, MD, MA, MPH
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Boston Medical Center.