Efficacy and Safety of Varenicline Among HIV-infected Patients

NCT00918307 | Completed Phase 3 DMC

• 2 other identifiers: 2008-007948-34ANRS 144
• Study Type: interventional
• Target: 248
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV Infections; Tobacco Dependence

Keywords

Tobacco Dependence; HIV infection; varenicline

Outcome Measures

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

  from week 9 to week 48

Secondary Outcomes (5)

• 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

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

  week 48

• Frequency of depressive episodes. Diagnosed by a psychiatrist

  continuously

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

  week 48

• Quality of life evaluation (SF-12)

  inclusion, W12, W24, W48

Study Arms (2)

Varenicline

EXPERIMENTAL

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

Drug: Varenicline

Placebo

PLACEBO COMPARATOR

placebo titrated to 2 pills twice daily for 12 weeks

Drug: Placebo

Interventions

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

Also known as: Champix

Varenicline

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ANRS, Emerging Infectious Diseases: lead
• Pfizer: collaborator

Study Sites (1)

CHU de Bordeaux

Bordeaux, 33075, France

Location

Related Publications (3)

• Mdege ND, Shah S, Dogar O, Pool ER, Weatherburn P, Siddiqi K, Zyambo C, Livingstone-Banks J. Interventions for tobacco use cessation in people living with HIV. Cochrane Database Syst Rev. 2024 Aug 5;8(8):CD011120. doi: 10.1002/14651858.CD011120.pub3.

  PMID: 39101506 DERIVED

• Hartmann-Boyce J, Theodoulou A, Farley A, Hajek P, Lycett D, Jones LL, Kudlek L, Heath L, Hajizadeh A, Schenkels M, Aveyard P. Interventions for preventing weight gain after smoking cessation. Cochrane Database Syst Rev. 2021 Oct 6;10(10):CD006219. doi: 10.1002/14651858.CD006219.pub4.

  PMID: 34611902 DERIVED

• Mercie P, Arsandaux J, Katlama C, Ferret S, Beuscart A, Spadone C, Duvivier C, Reynes J, Wirth N, Moinot L, Benard A, Zucman D, Duval X, Molina JM, Spire B, Fagard C, Chene G; ANRS 144 Inter-ACTIV study group. Efficacy and safety of varenicline for smoking cessation in people living with HIV in France (ANRS 144 Inter-ACTIV): a randomised controlled phase 3 clinical trial. Lancet HIV. 2018 Mar;5(3):e126-e135. doi: 10.1016/S2352-3018(18)30002-X. Epub 2018 Jan 9.

  PMID: 29329763 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

HIV Infections; Tobacco Use Disorder

Interventions

Varenicline

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines

Study Officials

• Patrick MERCIE, MD

  CHU de Bordeaux, F-33000

  PRINCIPAL INVESTIGATOR

• Geneviève CHENE, MD, PHD

  INSERM U897

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2009
• First Posted: June 11, 2009
• Study Start: October 1, 2009
• Primary Completion: January 1, 2014
• Study Completion: July 1, 2014
• Last Updated: July 29, 2014

Record last verified: 2014-07

Locations

FR (1)