Alcohol's Impact on Inflammatory Markers in HIV Disease - Russia ARCH Cohort
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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 |
- Microbial translocation as measured by soluble CD14 (sCD14) [ Time Frame: Participants will be followed for up to 3 years ] [ Designated as safety issue: No ]
- 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) |
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 |
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.
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01614626
| Contact: Jeffrey Samet, MD, MA, MPH | (617)-414-7288 | jsamet@bu.edu |
| Russian Federation | |
| Pavlov State Medical University | Recruiting |
| St. Petersburg, Russian Federation | |
| 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:
|
Acquired Immunodeficiency Syndrome Alcohol Drinking HIV Infections Drinking Behavior Immune System Diseases Immunologic Deficiency Syndromes Lentivirus Infections |
RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Virus Diseases |
ClinicalTrials.gov processed this record on February 26, 2015