The advent of anti-retroviral therapy (ART) for people living with HIV/AIDS (PLWHA)
substantially improved life expectancy but has also led to the critical need to address
modifiable risk factors associated with cancer and cardiovascular disease, such as tobacco
smoking. HIV-infected smokers lose more life-years due to tobacco use than they do to their
HIV infection.
There have been relatively few studies of tobacco use treatments for PLWHA and systematic
reviews show that there are insufficient data to conclude that tobacco dependence
interventions that are efficacious in the general population are efficacious for PLWHA.
Further, many studies in this area have lacked randomization and a control group,
infrequently used an intent-to-treat (ITT) approach and biological verification of tobacco
abstinence, and lacked post-treatment follow-up.10 What investigators do know thus far is
that behavioral interventions and the nicotine patch yield moderate effects on cessation; and
2 recent placebo-controlled trials - one in France and one by this lab - found that
varenicline is safe and effective for treating tobacco use among PLWHA, but yield quit rates
that are substantially lower than those reported in the general population. Thus, there is a
critical need to rigorously test novel ways to optimize tobacco cessation treatment for
smokers with HIV.
Phase:
Phase 3
Details
Lead Sponsor:
University of Pennsylvania
Collaborators:
National Cancer Institute (NCI) Northwestern University