Alcohol's Impact on Inflammatory Markers in HIV Disease - Russia ARCH Cohort
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Purpose
| 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 ]
- 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 ]
Biospecimen Retention: Samples With DNA
| Estimated Enrollment: | 375 |
| Actual Study Start Date: | November 2012 |
| Estimated Study Completion Date: | October 2017 |
| Estimated Primary Completion Date: | October 2017 (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 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
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| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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
Contacts and Locations
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01614626
| Russian Federation | |
| Pavlov State Medical University | |
| St. Petersburg, Russian Federation | |
| Principal Investigator: | Jeffrey Samet, MD, MA, MPH | Boston Medical Center |
More Information
Additional Information:
| Responsible Party: | Jeffrey Samet, Chief, Section of General Internal Medicine, Boston Medical Center |
| ClinicalTrials.gov Identifier: | NCT01614626 History of Changes |
| Other Study ID Numbers: |
H-31200 U01AA020780 ( U.S. NIH Grant/Contract ) |
| First Submitted: | May 25, 2012 |
| First Posted: | June 8, 2012 |
| Last Update Posted: | July 21, 2017 |
| Last Verified: | July 2017 |
| Studies a U.S. FDA-regulated Drug Product: | No | |
| Studies a U.S. FDA-regulated Device Product: | No | |
Keywords provided by Jeffrey Samet, Boston Medical Center:
|
HIV Alcohol Use Microbial Translocation |
Inflammation Altered Coagulation Russia |
Additional relevant MeSH terms:
|
HIV Infections Alcohol Drinking Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases |
Immunologic Deficiency Syndromes Immune System Diseases Drinking Behavior Slow Virus Diseases Ethanol Anti-Infective Agents, Local Anti-Infective Agents Central Nervous System Depressants Physiological Effects of Drugs |