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

NCT01614626 | Completed DMC

• 2 other identifiers: H-31200U01AA020780
• Study Type: observational
• Target: 351
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infection; Alcohol Use

Keywords

HIV; Alcohol Use; Microbial Translocation; Inflammation; Altered Coagulation; Russia

Outcome Measures

Primary Outcomes (1)

• Microbial translocation as measured by soluble CD14 (sCD14)

  Participants will be followed for up to 3 years

Secondary Outcomes (2)

• Inflammation/altered coagulation as measured by IL-6/D-dimer

  Participants will be followed for up to 3 years

• Alcohol's association with immunologic aging as measured by flow cytometry

  Participants will be followed for up to 3 years

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Not fluent in Russian
• Cognitive impairment resulting in inability to provide informed consent

Sponsors & Collaborators

• Boston Medical Center: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Pavlov State Medical University

Saint Petersburg, Russia

Location

Related Links

• Related Info

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

HIV Infections; Alcohol Drinking; Inflammation

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Drinking Behavior; Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jeffrey Samet, MD, MA, MPH

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Section of General Internal Medicine

Study Record Dates

• First Submitted: May 25, 2012
• First Posted: June 8, 2012
• Study Start: November 1, 2012
• Primary Completion: April 1, 2018
• Study Completion: December 15, 2020
• Last Updated: December 17, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)