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

July 28, 2014 updated by: ANRS, Emerging Infectious Diseases

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

248

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 33075
        • CHU de Bordeaux

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Varenicline
Varenicline titrated to 2 x 0.5 mg twice daily for 12 weeks
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
Other Names:
  • Champix
Placebo Comparator: Placebo
placebo titrated to 2 pills twice daily for 12 weeks
Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
from week 9 to week 48

Secondary Outcome Measures

Outcome Measure
Time Frame
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
from week 9 to week 12
Change in Lung capacity (FEV1 and FVC) between inclusion and week 48
Time Frame: week 48
week 48
Frequency of depressive episodes. Diagnosed by a psychiatrist
Time Frame: continuously
continuously
Change in cardiovascular risk score (Framingham and PROCAM scores) between inclusion and week 48.
Time Frame: week 48
week 48
Quality of life evaluation (SF-12)
Time Frame: inclusion, W12, W24, W48
inclusion, W12, W24, W48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ANRS, Emerging Infectious Diseases

Collaborators

Pfizer

Investigators

  • Principal Investigator: Patrick MERCIE, MD, CHU de Bordeaux, F-33000
  • Study Chair: Geneviève CHENE, MD, PHD, INSERM U897

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

June 9, 2009

First Submitted That Met QC Criteria

June 9, 2009

First Posted (Estimate)

June 11, 2009

Study Record Updates

Last Update Posted (Estimate)

July 29, 2014

Last Update Submitted That Met QC Criteria

July 28, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008-007948-34
  • ANRS 144

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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