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

HIV Infection Clinical Trial

Official title:

Alcohol & Zinc Impact on Inflammatory Markers in HIV Disease - Russia ARCH Cohort

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01614626
• Other study ID #: H-31200
• Secondary ID: U01AA020780
• Status: Completed
• Start date: November 2012
• Est. completion date: December 15, 2020

Study information

• Verified date: December 2020
• Source: Boston Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 351
• Est. completion date: December 15, 2020
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use
• HIV Infection

Locations

Country	Name	City	State
Russian Federation	Pavlov State Medical University	St. Petersburg

Sponsors (2)

Lead Sponsor	Collaborator
Boston Medical Center	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Microbial translocation as measured by soluble CD14 (sCD14)		Participants will be followed for up to 3 years
Secondary	Inflammation/altered coagulation as measured by IL-6/D-dimer		Participants will be followed for up to 3 years
Secondary	Alcohol's association with immunologic aging as measured by flow cytometry		Participants will be followed for up to 3 years

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