142nd APHA Annual Meeting and Exposition

Annual Meeting Recordings are now available for purchase

Design of an RCT evaluating zinc supplementation to prevent progression of HIV disease among heavy drinkers in the Russia ARCH cohort

142nd APHA Annual Meeting and Exposition (November 15 - November 19, 2014): http://www.apha.org/events-and-meetings/annual
Wednesday, November 19, 2014 : 1:10 PM - 1:30 PM

Jeffrey Samet, MD, MA, MPH , Boston Medical Center/Boston University School of Medicine, Boston, MA
Debbie Cheng, ScD , Department of Biostatistics, Boston University School of Public Health, Boston
Elena Blokhina, MD, PhD , First St. Petersburg Pavlov State Medical University, Russia
Natalia Gnatienko, MPH , Boston Medical Center, Boston, MA
Christine Chaisson, MPH , Data Coordinating Center, Boston University School of Public Health, Boston, MA
Evgeny Krupitsky, MD, PhD, DMSci , First St. Petersburg Pavlov State Medical University/St. Petersburg Bekhterev Research Psychoneurological Institute, Russia
Matthew Freiberg, MD, MSc , Cardiovascular Medicine Division, Vanderbilt University Medical Center, Nashville, TN
Alcohol use among HIV-infected individuals is common and associated with worse clinical outcomes. Alcohol use and HIV each lead to microbial translocation, which in turn results in inflammation. Zinc supplementation has shown promise in slowing microbial translocation.  Given partial effectiveness of interventions to mitigate alcohol use, zinc supplementation holds potential for being a low cost intervention to mitigate the consequences of ongoing alcohol use. 

We are conducting a double-blinded RCT in Russia (n=250) to evaluate the efficacy of zinc vs. placebo in improving markers of 1) mortality risk; 2) HIV disease progression; 3) cardiovascular risk; and 4) microbial translocation and inflammation.  Participants, who are ART-naïve at enrollment and report recent heavy alcohol use, are randomized to zinc (15 mg men; 12 mg women) or placebo, daily for 18 months. Assessments occur at baseline, 6, 12, and 18 months. Adherence is measured using direct (riboflavin) and indirect (pill count, self-report) measures. Enrollment began in October 2013 and is expected to conclude by February 2015.

Russia with both high HIV prevalence and alcohol use provides a unique setting for this study.  As HIV infection and alcohol use both result in pro-inflammatory states, this dual vulnerability is an ideal condition in which to study the effects of zinc on improving health outcomes.  Russia’s many HIV-infected persons not as yet eligible for ART enables this study to examine the effects of zinc on inflammation separate from ART. Study design and protocol will be the focus of this presentation.

Learning Areas:

Public health or related research

Learning Objectives:
Describe the design of an RCT evaluating the efficacy of zinc supplementation on markers of mortality risk and HIV disease progression. Explain why Russia offers a unique setting to study the impact of zinc on inflammation. Describe how the study contributes to the international alcohol and HIV/AIDS body of research.

Keyword(s): Alcohol Use, HIV/AIDS

Presenting author's disclosure statement:

Qualified on the content I am responsible for because: I am a general internal medicine physician, cardiovascular epidemiologist, tenured associate professor of medicine, and director of the Vanderbilt Center for Clinical Cardiovascular outcomes Research and Trials Evaluation (V-C3REATE) within the Division of Cardiovascular Medicine at Vanderbilt. My research focuses on intersections between HIV infection, substance use, immune function, and cardiovascular disease outcomes. This work includes epidemiological studies, mechanistic studies, and randomized clinical trial within the Veterans Affairs Medical Centers and in St. Petersburg, Russia.
Any relevant financial relationships? No

I agree to comply with the American Public Health Association Conflict of Interest and Commercial Support Guidelines, and to disclose to the participants any off-label or experimental uses of a commercial product or service discussed in my presentation.