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Completed

NCT Number: NCT00918307

Efficacy and Safety of Varenicline Among HIV-infected Patients

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.

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Key information

Conditions

HIV Infections Blood-Borne Infections Chemically-Induced Disorders Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Mental Disorders RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Substance-Related Disorders Tobacco Dependence Tobacco Use Disorder Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CHU de Bordeaux

Bordeaux, 33075, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Varenicline

Drug

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

Other names: Champix

Placebo

Drug

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

Primary outcomes

  1. Continuous abstinence from smoking from week 9 to week 48 without the use of any other smoking cessation treatments other than trials' treatment

    Time frame: from week 9 to week 48

Secondary outcomes

  1. Continuous abstinence from smoking from week 9 to week 12 without the use of any other smoking cessation treatments other than trials' treatment

    Time frame: from week 9 to week 12

  2. Change in Lung capacity (FEV1 and FVC) between inclusion and week 48

    Time frame: week 48

  3. Frequency of depressive episodes. Diagnosed by a psychiatrist

    Time frame: continuously

  4. Change in cardiovascular risk score (Framingham and PROCAM scores) between inclusion and week 48.

    Time frame: week 48

  5. Quality of life evaluation (SF-12)

    Time frame: inclusion, W12, W24, W48

Sponsors and collaborators

Lead sponsor

ANRS, Emerging Infectious Diseases

Other Gov

Collaborators

  • Pfizer

Registry information

Official study title

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

Acronym: Inter-ACTIV

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Jun 11, 2009
Registry last updated
Jul 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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