Efficacy and Safety of Varenicline Among HIV-infected Patients

HIV Infections Clinical Trial

— Inter-ACTIV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00918307
• Other study ID #: 2008-007948-34
• Secondary ID: ANRS 144
• Status: Completed
• Phase: Phase 3
• First received: June 9, 2009
• Last updated: July 28, 2014
• Start date: October 2009
• Est. completion date: July 2014

Study information

• Verified date: July 2014
• Source: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 248
• Est. completion date: July 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections
• Tobacco Dependence
• Tobacco Use Disorder

Intervention

Drug:
• Varenicline
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
• Placebo
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

Locations

Country	Name	City	State
France	CHU de Bordeaux	Bordeaux

Sponsors (2)

Lead Sponsor	Collaborator
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)	Pfizer

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Change in Lung capacity (FEV1 and FVC) between inclusion and week 48		week 48	No
Secondary	Frequency of depressive episodes. Diagnosed by a psychiatrist		continuously	Yes
Secondary	Change in cardiovascular risk score (Framingham and PROCAM scores) between inclusion and week 48.		week 48	No
Secondary	Quality of life evaluation (SF-12)		inclusion, W12, W24, W48	No

External Links

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