Efficacy and Safety of Varenicline Among HIV-infected Patients (Inter-ACTIV)

ANRS, Emerging Infectious Diseases

Status and phase: Completed; Phase 3

Conditions: Tobacco Dependence; HIV Infections

Treatments: Drug: Varenicline; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00918307

ANRS 144

2008-007948-34

Details and patient eligibility

About

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.

Full 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.

Enrollment: 248 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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248 participants in 2 patient groups, including a placebo group

Varenicline

Experimental group

Description:

Varenicline titrated to 2 x 0.5 mg twice daily for 12 weeks

Treatment:

Drug: Varenicline

Placebo

Placebo Comparator group

Description:

placebo titrated to 2 pills twice daily for 12 weeks

Treatment:

Drug: Placebo