Trial record 6 of 32 for:    " May 09, 2012":" June 08, 2012"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Boston Medical Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jeffrey Samet, Boston Medical Center
ClinicalTrials.gov Identifier:
NCT01614626
First received: May 25, 2012
Last updated: August 22, 2014
Last verified: August 2014
  Purpose

The purpose of this study is to assess the longitudinal association between alcohol consumption and biomarkers of microbial translocation (sCD14) and inflammation/altered coagulation (D-dimer); to establish a cohort of HIV-infected Russian drinkers; and to establish a sample repository.


Condition
HIV Infection
Alcohol Use

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Alcohol & Zinc Impact on Inflammatory Markers in HIV Disease - Russia ARCH Cohort

Resource links provided by NLM:


Further study details as provided by Boston Medical Center:

Primary Outcome Measures:
  • Microbial translocation as measured by soluble CD14 (sCD14) [ Time Frame: Participants will be followed for up to 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Inflammation/altered coagulation as measured by D-dimer [ Time Frame: Participants will be followed for up to 3 years ] [ Designated as safety issue: No ]
  • Alcohol's association with immunologic aging as measured by flow cytometry [ Time Frame: Participants will be followed for up to 3 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

We are storing serum and plasma for future use, as well as dried blood spots for PEth testing.


Estimated Enrollment: 375
Study Start Date: November 2012
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
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 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 altered coagulation (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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  • Not on ART at the time of enrollment

Exclusion Criteria:

  • Not fluent in Russian
  • Cognitive impairment resulting in inability to provide informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01614626

Contacts
Contact: Jeffrey Samet, MD, MA, MPH (617)-414-7288 jsamet@bu.edu

Locations
Russian Federation
Pavlov State Medical University Recruiting
St. Petersburg, Russian Federation
Sponsors and Collaborators
Boston Medical Center
Investigators
Principal Investigator: Jeffrey Samet, MD, MA, MPH Boston Medical Center
  More Information

Additional Information:
No publications provided

Responsible Party: Jeffrey Samet, Chief, Section of General Internal Medicine, Boston Medical Center
ClinicalTrials.gov Identifier: NCT01614626     History of Changes
Other Study ID Numbers: U01AA020780, U01AA020780
Study First Received: May 25, 2012
Last Updated: August 22, 2014
Health Authority: United States: Federal Government

Keywords provided by Boston Medical Center:
HIV
Alcohol Use
Microbial Translocation
Inflammation
Altered Coagulation
Russia

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Alcohol Drinking
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Drinking Behavior

ClinicalTrials.gov processed this record on September 18, 2014