HIV Infections, Tobacco Dependence
Conditions
Keywords
Tobacco Dependence, HIV infection, varenicline
Brief summary
Cigarette smoking is a major cause of illness among HIV-infected patients (non-AIDS defining malignancies (especially lung cancer), non-AIDS bacterial infections and cardio-vascular diseases). Approximately 50% of HIV-infected patients are regular tobacco smokers. Tobacco smoking cessation has well known benefits on mortality and morbidity in the general population where tobacco cessation assistance programs are increasingly implemented. However, smoking cessation interventions have never been evaluated among HIV-infected patients. This trial aims at evaluating the efficacy and safety of varenicline for smoking cessation compared with placebo.
Detailed description
Cigarette smoking is a major cause of illness among HIV-infected patients (non-AIDS defining malignancies (especially lung cancer), non-AIDS bacterial infections and cardio-vascular diseases). Approximately 50% of HIV-infected patients are regular tobacco smokers. Tobacco smoking cessation has well known benefits on mortality and morbidity in the general population where tobacco cessation assistance programs are increasingly implemented. However, smoking cessation interventions have never been evaluated among HIV-infected patients. This trial aims at evaluating the efficacy and safety of varenicline for smoking cessation compared with placebo. A pharmacokinetic study will be conducted to evaluate the effect of smoking cessation on the plasma concentration of antiretroviral treatment.
Interventions
DRUGVarenicline
Day 1 to day 3 : 0.5 mg daily ; Day 4 to day 7 : 0.5 mg twice daily ; Day 8 to week 12 : 2 x 0.5 mg twice daily
DRUGPlacebo
Day 1 to day 3 : 1 pill daily ; Day 4 to day 7 : 2 pills daily ; Day 8 to week 12 : 2 pills twice daily
Sponsors
Pfizer
ANRS, Emerging Infectious Diseases
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* HIV-infected patients * adults * regular smokers (at least 10 cigarettes a day during the last year) * motivated to stop smoking * followed in one of the participating clinical ward, * signed written inform consent
Exclusion criteria
* current co-dependency to another psychoactive substance * ongoing depressive episode * history of suicidal attempt * ongoing treatment by interferon * treatment by efavirenz for less than three months or not tolerated * previous use of varenicline * ongoing treatment by bupropion-SR or nicotinic substitute * ongoing pregnancy * ongoing breastfeeding * hypersensitivity to varenicline or to one of its excipients * drivers, air traffic controller
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Continuous abstinence from smoking from week 9 to week 48 without the use of any other smoking cessation treatments other than trials' treatment | from week 9 to week 48 |
Secondary
| Measure | Time frame |
|---|---|
| Continuous abstinence from smoking from week 9 to week 12 without the use of any other smoking cessation treatments other than trials' treatment | from week 9 to week 12 |
| Change in Lung capacity (FEV1 and FVC) between inclusion and week 48 | week 48 |
| Frequency of depressive episodes. Diagnosed by a psychiatrist | continuously |
| Change in cardiovascular risk score (Framingham and PROCAM scores) between inclusion and week 48. | week 48 |
| Quality of life evaluation (SF-12) | inclusion, W12, W24, W48 |
Countries
France
Outcome results
None listed