Efficacy and Safety of Varenicline Among HIV-infected Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparison of the Efficacy and Safety of Varenicline Versus Placebo for Smoking Cessation Among HIV-infected Patients. A Randomized Double Blind Controlled Trial

Conditions
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HIV Infections, Tobacco Dependence

Intervention / Treatment
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* Drug: Varenicline
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Varenicline<br>Varenicline titrated to 2 x 0.5 mg twice daily for 12 weeks | Drug: Varenicline<br>* 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<br>* Other names: Champix;|
| Placebo Comparator: Placebo<br>placebo titrated to 2 pills twice daily for 12 weeks | Drug: Placebo<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tobacco Dependence, HIV infection, varenicline