Design of a randomized controlled trial of zinc supplementation to improve markers of mortality and HIV disease progression in HIV-positive drinkers in St. Petersburg, Russia.
Natalia GnatienkoMatthew S FreibergElena BlokhinaTatiana YaroslavtsevaCarly BriddenDebbie M ChengChristine E ChaissonDmitry LioznovSally BendiksGlory KoerbelSharon M ColemanEvgeny KrupitskyJeffrey H SametPublished in: HIV clinical trials (2018)
Background Russia continues to have an uncontrolled HIV epidemic and its per capita alcohol consumption is among the highest in the world. Alcohol use among HIV-positive individuals is common and is associated with worse clinical outcomes. Alcohol use and HIV each lead to microbial translocation, which in turn results in inflammation. Zinc supplementation holds potential for lowering levels of biomarkers of inflammation, possibly as a consequence of its impact on intestinal permeability. This paper describes the protocol of a double-blinded randomized placebo-controlled trial of zinc supplementation in St. Petersburg, Russia. Methods Participants (n = 254) were recruited between October 2013 and June 2015 from HIV and addiction clinical care sites, and non-clinical sites in St. Petersburg, Russia. Participants were randomly assigned, to receive either zinc (15 mg for men; 12 mg for women) or placebo, daily for 18 months. The following outcomes were assessed at 6, 12, and 18 months: (1) mortality risk (primary outcome at 18 months); (2) HIV disease progression; (3) cardiovascular risk; and (4) microbial translocation and inflammation. Adherence was assessed using direct (riboflavin) and indirect (pill count, self-report) measures. Conclusion Given the limited effectiveness of current interventions to reduce alcohol use, zinc supplementation merits testing as a simple, low-cost intervention to mitigate the consequences of alcohol use in HIV-positive persons despite ongoing drinking.
Keyphrases
- hiv positive
- antiretroviral therapy
- men who have sex with men
- south africa
- alcohol consumption
- hiv testing
- human immunodeficiency virus
- hiv infected
- oxidative stress
- randomized controlled trial
- double blind
- hiv aids
- oxide nanoparticles
- low cost
- physical activity
- microbial community
- open label
- coronary artery disease
- type diabetes
- metabolic syndrome
- study protocol
- adipose tissue
- clinical trial
- insulin resistance
- cardiovascular events
- skeletal muscle
- chronic pain
- placebo controlled
- pain management
- human health
- health insurance
- sensitive detection
- pregnancy outcomes
- affordable care act