# URBAN ARCH 4/5 Russia Cohort-Targeting HIV-comorbidities with Pharmacotherapy to Reduce Alcohol and Tobacco Use in HIV-infected Russians

> **NIH NIH U01** · BOSTON MEDICAL CENTER · 2021 · $147,070

## Abstract

HIV infected (HIV+) heavy drinking smokers are at high risk for coronary heart disease (CHD) and death. The
mechanisms driving increased CHD risk in HIV+ people are unclear, but are linked to inflammation. HIV, heavy
drinking, and smoking are all pro-inflammatory. HIV viral suppression with antiretroviral therapy does not
eliminate the elevated CHD risk nor the increased inflammation (i.e., pre-HIV infection levels are not restored).
Interventions that reduce alcohol use, smoking, or both in HIV+ people could lower inflammation, CHD and
death risk. Varenicline and cytisine are proven therapies for smoking cessation. When compared to placebo,
varenicline has higher cessation rates than cytisine. Human trials suggest varenicline also has efficacy for
reducing alcohol consumption and craving in heavy drinking smokers. In murine models, cytisine reduces
alcohol consumption. The comparative efficacy of varenicline and cytisine to reduce alcohol consumption and
by extension, inflammation, CHD, and mortality risk, in humans has not been tested, nor has their comparative
effectiveness been tested for smoking. Neither drug has been tested for smoking cessation against nicotine
replacement therapy (NRT) in HIV+ heavy drinking smokers. Three compelling reasons to test varenicline and
cytisine in HIV+ heavy drinking smokers are: 1) both show promise in HIV-uninfected people; 2) the morbidity
caused by heavy drinking and smoking in HIV+ persons is significant; and 3) treating heavy drinking and
smoking with one medication represents a significant advance in reducing polypharmacy and improving patient
care. Thus, we propose a 4-arm placebo-controlled randomized controlled trial (RCT) among 400 HIV+ heavy
drinking smokers. Trial arms are varenicline+NRT placebo, cytisine+NRT placebo, NRT+varenicline placebo,
NRT+cytisine placebo. All participants will receive counseling (alcohol & tobacco) and medications (placebo &
active). Our specific aims will compare effects of varenicline, cytisine, and NRT at 3 months on past month %
heavy drinking days and alcohol craving, cigarettes per day and smoking abstinence (verified by carbon
monoxide), inflammation (hsCRP, IL-6), CHD (Reynolds risk score), and mortality (VACS index) risk. We
hypothesize that (1) Varenicline has greater efficacy than NRT for reducing heavy drinking, smoking,
inflammation, CHD and mortality risk; (2) Cytisine has greater efficacy than NRT; and (3) Varenicline has
greater efficacy than cytisine for these outcomes. We will conduct an RCT, Studying Partial-agonists for
Ethanol and Tobacco Elimination in Russians with HIV (St PETER HIV), in a country with an HIV epidemic and
high per-capita alcohol consumption and smoking. We will recruit from our ongoing Russia ARCH cohort in St.
Petersburg (part of our NIAAA funded HIV/AIDS Alcohol Consortium – URBAN ARCH). If our hypotheses are
correct, St PETER HIV could make nicotinic partial-agonists standard care for HIV+ heavy drinking smokers,
and lead to re...

## Key facts

- **NIH application ID:** 10425848
- **Project number:** 3U01AA020780-10S2
- **Recipient organization:** BOSTON MEDICAL CENTER
- **Principal Investigator:** MATTHEW S FREIBERG
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $147,070
- **Award type:** 3
- **Project period:** 2011-09-20 → 2022-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10425848

## Citation

> US National Institutes of Health, RePORTER application 10425848, URBAN ARCH 4/5 Russia Cohort-Targeting HIV-comorbidities with Pharmacotherapy to Reduce Alcohol and Tobacco Use in HIV-infected Russians (3U01AA020780-10S2). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10425848. Licensed CC0.

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