NCT04176172Active, not recruitingPhase 3
Optimizing Tobacco Use Treatment for PLWHA
Testing Novel Pharmacogenetic and Adherence Optimization Treatments to Improve the Effectiveness of Smoking Cessation Treatments for Smokers With HIV
Source: ClinicalTrials.gov · Last updated 4 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 340 (estimated)
- First submitted
- 21 Nov 2019
- Start date
- Feb 2020
- Primary completion date
- Nov 2026
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Diseases
- HIV
- NCT number
- NCT04176172
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 340
- From Feb 2020 to the primary completion date, Nov 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current use or discontinuation within last 14 days of quit smoking medications
- A reaction or sensitivity to a nicotine patch or any other transdermal medication requires study physician approval
Other illness
- Current diagnosis of unstable and untreated major depression, psychosis or bipolar disorder
- Cancer, heart disease, stroke or MI within the past 6 months requires study physician approval
- Uncontrolled hypertension
- History of epilepsy or seizure disorder requires study physician approval
Other
- Current untreated and unstable diagnosis of substance abuse/dependence
- Suicide risk as measured by the C-SSRS
- Women who are pregnant, planning a pregnancy, or lactating
- Use of e-cigarettes, chewing tobacco, snuff or snus
- Generalized eczema or psoriasis
- Currently participating in a smoking cessation program
Who the study is looking for
- \>18 years, smoke daily for the past 30 days
- Confirmed HIV+ (exhibit viral load of \<1000 copies/mL)
- Residing in the geographic area close to one of the sites for at least 7 months
- Able to use varenicline/TN patch safely
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Northwestern University Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| University of Pennsylvania Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.