Efficacy and Safety of Varenicline Among HIV-infected Patients

Phase 3

Completed

• Conditions: HIV Infections; Tobacco Dependence
• Interventions: Drug: Placebo; Drug: Varenicline

• Registration Number: NCT00918307
• Lead Sponsor: ANRS, Emerging Infectious Diseases

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.

Study Timeline

• Study First Submitted: 2009-06-09
• Study First Submitted QC: 2009-06-09
• Study First Posted: 2009-06-11
• Study Start: 2009-10
• Primary Completion: 2014-01
• Status Verified: 2014-07
• Study Completion: 2014-07
• Last Update Submitted: 2014-07-28
• Last Update Posted: 2014-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 248

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	placebo titrated to 2 pills twice daily for 12 weeks
Varenicline	Varenicline	Varenicline titrated to 2 x 0.5 mg twice daily for 12 weeks

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Change in Lung capacity (FEV1 and FVC) between inclusion and week 48	week 48
Frequency of depressive episodes. Diagnosed by a psychiatrist	continuously
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 cardiovascular risk score (Framingham and PROCAM scores) between inclusion and week 48.	week 48
Quality of life evaluation (SF-12)	inclusion, W12, W24, W48

Trial Locations

Locations (1)

CHU de Bordeaux; 🇫🇷 Bordeaux, France