St PETER HIV:
A summary of the Russia ARCH cohort renewal study (2016-2021)
HIV-infected individuals with heavy drinking and smoking are at high risk for future HIV-associated comorbidities, such as coronary heart disease (CHD). The Studying Partial-agonists for Ethanol and Tobacco Elimination in Russians with HIV (St PETER HIV) study will continue to follow and expand the existing Russia ARCH cohort to conduct a randomized controlled trial to compare the effects of varenicline, cytisine, and nicotine replacement therapy (NRT) on alcohol use and craving; smoking; inflammation; and CHD and mortality risk. Varenicline and cytisine are both nicotinic partial-agonists and proven therapies for smoking cessation. Cytisine, which is used in Europe, is less expensive than varenicline; however, only varenicline is FDA approved for use in the United States. Both medications hold promise as therapeutic agents that could simultaneously reduce alcohol consumption and increase tobacco cessation. Russia is a unique setting to conduct the St PETER HIV study as HIV infection, alcohol consumption, and smoking are highly prevalent and cytisine is available.
The study’s specific aims will compare effects of varenicline, cytisine, and NRT on three major conditions responsible for serious morbidity and mortality among HIV-infected people:
- Percentage of heavy drinking days in the past month (self-report, primary outcome) and alcohol craving (self-report);
- Cigarettes per day (past week, self-report); 7-day point prevalence abstinence (biochemically verified);
- Inflammation (hsCRP, IL-6), CHD risk (Reynolds risk score), and mortality risk (VACS index).
The St PETER study team hypothesizes that: 1) varenicline will have greater effects than NRT for reducing alcohol consumption, smoking, inflammation, coronary heart disease, and mortality risk; 2) cytisine will have greater effects than NRT for these outcomes; and 3) varenicline will have greater effects than cytisine for these outcomes. The design of the randomized control trial is as follows:
- Principal Investigators:
- Matthew Freiberg, MD, MSc, Director of the Vanderbilt Center for Clinical Cardiovascular outcomes REsearch And Trials Evaluation (V-C3REATE) and Associate Professor of Medicine at the Vanderbilt University Medical Center
- Jeffrey Samet, MD, MA, MPH, Chief of the Section of General Internal Medicine at Boston Medical Center and John Noble, MD Professor of Medicine and Professor of Community Health Sciences,at the Boston University Schools of Public Health and Medicine
- Hilary Tindle, MD, MPH, Founding Director of the Vanderbilt Center for Tobacco, Addiction and Lifestyle (ViTAL) and Associate Professor of Medicine at Vanderbilt University
- Elena Blokhina, MD, PhD, Deputy Director of the Valdman Institute of Pharmacology at the First St. Petersburg Pavlov State Medical University
- Evgeny Krupitsky, MD, PhD, Chief of the Lab of Clinical Pharmacology of Addictions at the Pavlov State Medical University and Chief of the Department of Addictions at the St. Petersburg Bekhterev Psychoneurological Research Institute
- Dmitry Lioznov, MD, PhD, Head, Department of Infectious Disease, at the First St. Petersburg Pavlov State Medical University
- Michael Stein, MD, Professor and Chair of the Department of Health Law, Policy & Management at the Boston University School of Public Health
- Edwin Zvartau, MD, PhD, Head of the Department of Clinical Pharmacology & Evidence-Based Med and Research Director of the Valdman Institute of Pharmacology at the First St. Petersburg Pavlov State Medical University
- Study Biostatistician:
- Debbie Cheng, ScD, Professor of Biostatistics at the Boston University School of Public Health
- Study Managers:
Data will be collected from participants in the St PETER trial, via in-person assessments and phlebotomy, at baseline, 1, 3, 6, and 12 months. Additional medication check-ins will occur weekly for the first four weeks of the study, and biweekly beginning in week four while participants are taking study medication Participants will receive daily text message reminders to encourage medication adherence. Adherence will be monitored by study staff through pill counts, self-report, and directly through the use of riboflavin, a vitamin added to both active and placebo capsules, which yields a change in urine color and remains in the system at detectable levels for up to 24 hours. Participants in all study arms will also receive brief evidence-based counseling for alcohol and tobacco use at baseline.
Study recruitment will begin in the spring of 2017. If the study’s hypotheses are correct, St PETER HIV could make nicotinic partial-agonists standard care for HIV-infected heavy drinking smokers, and lead to reduced inflammation, CHD and mortality risk through this “one drug, two diseases” approach.
Want to learn more about St PETER? Click here or our January – March 2017 newsletter issue spotlights Hilary Tindle here.