Efficacy and Safety of Varenicline Among HIV-infected Patients

• Status: Completed
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ANRS, Emerging Infectious Diseases; French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
• Collaborator: Pfizer
• Treatments: Varenicline

Criteria

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

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