We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01614626
Recruitment Status : Completed
First Posted : June 8, 2012
Last Update Posted : December 17, 2020
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Jeffrey Samet, Boston Medical Center

Tracking Information
First Submitted Date May 25, 2012
First Posted Date June 8, 2012
Last Update Posted Date December 17, 2020
Actual Study Start Date November 2012
Actual Primary Completion Date April 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 6, 2012)
Microbial translocation as measured by soluble CD14 (sCD14) [ Time Frame: Participants will be followed for up to 3 years ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 15, 2016)
  • 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 ]
Original Secondary Outcome Measures
 (submitted: June 6, 2012)
  • Inflammation/altered coagulation as measured by 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
We are storing serum and plasma for future use, as well as dried blood spots for PEth testing.
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.
Condition
  • HIV Infection
  • Alcohol Use
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 20, 2018)
351
Original Estimated Enrollment
 (submitted: June 6, 2012)
250
Actual Study Completion Date December 15, 2020
Actual Primary Completion Date April 2018   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Russian Federation
Removed Location Countries  
 
Administrative Information
NCT Number NCT01614626
Other Study ID Numbers H-31200
U01AA020780 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Jeffrey Samet, Boston Medical Center
Original Responsible Party Same as current
Current Study Sponsor Boston Medical Center
Original Study Sponsor Same as current
Collaborators National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
Principal Investigator: Jeffrey Samet, MD, MA, MPH Boston Medical Center
PRS Account Boston Medical Center
Verification Date December 2020