HIV InfectionsPhase 3Inter-ACTIVNCT00918307
Efficacy and Safety of Varenicline Among HIV-infected Patients
A Phase 3 study testing Varenicline in people with HIV Infections and Tobacco Dependence, run by ANRS, Emerging Infectious Diseases at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections, Tobacco Dependence
- What is being tested?
- Varenicline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 248 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2009to Jul 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- HIV Infections, Tobacco Dependence
- Being tested
- Varenicline, Placebo
- Keywords
- Tobacco Dependence, HIV infection, varenicline
- Medical subject headings
- HIV Infections, Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VareniclineDrug
Also called Champix
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
PlaceboDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Varenicline | Experimental | Varenicline titrated to 2 x 0.5 mg twice daily for 12 weeks Receives: Drug: Varenicline |
| Placebo | Placebo comparator | placebo titrated to 2 pills twice daily for 12 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Continuous abstinence from smoking from week 9 to week 48 without the use of any other smoking cessation treatments other than trials' treatment
Measured: 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
Measured: from week 9 to week 12
Change in Lung capacity (FEV1 and FVC) between inclusion and week 48
Measured: week 48
Frequency of depressive episodes. Diagnosed by a psychiatrist
Measured: continuously
Change in cardiovascular risk score (Framingham and PROCAM scores) between inclusion and week 48.
Measured: week 48
Quality of life evaluation (SF-12)
Measured: inclusion, W12, W24, W48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2009 (estimated)
- Study startOct 2009
- Primary completionJan 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by ANRS, Emerging Infectious DiseasesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 248 participants (actual)
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Patrick MERCIE, MD, Principal investigator, CHU de Bordeaux, F-33000Geneviève CHENE, MD, PHD, Study chair, INSERM U897
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00918307
- Sponsor's protocol ID
- 2008-007948-34
- Other IDs
- ANRS 144, 2008
- Acronym
- Inter-ACTIV
- Status last verified
- Jul 2014
- First submitted
- 9 Jun 2009
- Last updated
- 29 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 39101506Hartmann-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.
PubMed 34611902Mercie 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.
PubMed 29329763
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00918307
- Acronym / sponsor ID
- Inter-ACTIV / 2008-007948-34
- Conditions
- HIV Infections, Tobacco Dependence
- Keywords
- Tobacco Dependence, HIV infection, varenicline
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 248 participants (actual)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Collaborators
- Pfizer
- Study start
- Oct 2009
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 11 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Varenicline | Experimental | Drug: VareniclineVarenicline titrated to 2 x 0.5 mg twice daily for 12 weeks |
| Placebo | Placebo comparator | Drug: Placeboplacebo titrated to 2 pills twice daily for 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VareniclineAlso: ChampixDay 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 | Drug | Varenicline |
| PlaceboDay 1 to day 3 : 1 pill daily ; Day 4 to day 7 : 2 pills daily ; Day 8 to week 12 : 2 pills twice daily | Drug | Placebo |
Primary outcome
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
5 secondary outcomes
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
Change in Lung capacity (FEV1 and FVC) between inclusion and week 48
Time frame: week 48
Frequency of depressive episodes. Diagnosed by a psychiatrist
Time frame: continuously
Change in cardiovascular risk score (Framingham and PROCAM scores) between inclusion and week 48.
Time frame: week 48
Quality of life evaluation (SF-12)
Time frame: inclusion, W12, W24, W48
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2014.
- Derived from this study: PubMed 39101506Mdege 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.
- Derived from this study: PubMed 34611902Hartmann-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.
- Derived from this study: PubMed 29329763Mercie 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.
- Related InfoLink provided by the sponsor.
Related trials for HIV Infections
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick MERCIE, MD principal investigator
CHU de Bordeaux, F-33000
Geneviève CHENE, MD, PHD study chair
INSERM U897
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Varenicline in people with HIV Infections and Tobacco Dependence, run by ANRS, Emerging Infectious Diseases at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00918307, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2014.