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

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.