While approximately 80% of health care providers that treat HIV-infected patients believe that smoking is a major health issue affecting HIV-infected scientific study individuals, less than half report that they frequently prescribe nicotine replacement therapy (NRT), varenicline, or bupropion (Shuter, Salmo, Shuter, Nivasch, Fazzari, & Moadal, 2011). Also, there have been few studies that have examined the efficacy of tobacco dependence treatment pharmacotherapy in this population, and the studies that have been reported have used NRT and not other treatments such as varenicline (Lloyd-Richardson et al., 2009; Vidrine, Arduino, Lazev, & Gritz, 2006; Wewers, Neidig, & Kihm, 2000). Varenicline is an effective tobacco dependence treatment pharmacotherapy among healthy smokers (Cahill, Stead, & Lancaster, 2011; Fiore et al.

, 2008) and smokers with cardiovascular disease (Rigotti, Pipe, Benowitz, Arteaga, Garza, & Tonstad, 2010). However, a recent meta-analysis suggests that varenicline increases the risk of adverse cardiovascular events (Singh, Loke, Spangler, & Furberg, 2011). Further, a Food and Drug Administration (FDA) warning was issued in 2009, advising health care professionals about the risks of serious psychiatric symptoms in patients taking varenicline (FDA, 2009). Thus, the safety of this pharmacotherapy among HIV-infected smokers could be a concern given the increased risk of both cardiovascular disease and psychiatric problems in the HIV-infected population. In this paper, we report the safety of varenicline and NRT among HIV-infected individuals enrolled in a tobacco dependence treatment protocol as part of a prospective study.

Preliminary information regarding the effectiveness of varenicline in this population is also provided. Methods Participants The participants were recruited from one site of the Lung HIV study, a multisite study funded by the National Heart, Lung, and Blood Institute (R01HL090313-01). The overall objective of the Lung HIV study is to characterize HIV-associated lung infections and complications in the era of combination antiretroviral therapy (ART). The eight sites conduct independent projects as well as collaborative projects (Crothers et al., 2011). Our site is focused on examining longitudinal changes in lung function among HIV-infected smokers who quit, as compared with those who continue to smoke.

As such, study participants AV-951 were exposed to intensive tobacco dependence treatment in order to obtain the maximum number of abstinent individuals. Randomization was not used to assign participants to treatment, since our goal was to deliver the most efficacious therapy available based on the Clinical Practice Guideline (Fiore et al., 2008). To be eligible for this study, an individual had to be an adult infected with HIV, a daily smoker of five or more cigarettes, and interested in quitting smoking in the next 30 days.