Clinical trial NCT01614626: Alcohol's Impact on Inflammatory Markers in HIV Disease - Russia ARCH Cohort
Official title: Alcohol & Zinc Impact on Inflammatory Markers in HIV Disease - Russia ARCH Cohort
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infection
Alcohol Use
Keywords: HIV
Alcohol Use
Microbial Translocation
Inflammation
Altered Coagulation
Russia
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2012-06-08
Enrollment: 351
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Microbial translocation as measured by soluble CD14 (sCD14)
timeFrame: Participants will be followed for up to 3 years
Secondary outcomes:
measure: Inflammation/altered coagulation as measured by IL-6/D-dimer
timeFrame: Participants will be followed for up to 3 years
measure: Alcohol's association with immunologic aging as measured by flow cytometry
timeFrame: Participants will be followed for up to 3 years
Other outcomes:
Locations:
city: St. Petersburg
country: Russian Federation
facility: Pavlov State Medical University
Study officials:
affiliation: Boston Medical Center
name: Jeffrey Samet, MD, MA, MPH
role: PRINCIPAL_INVESTIGATOR
References: