Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| ANRS 144 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Varenicline | Experimental | Varenicline titrated to 2 x 0.5 mg twice daily for 12 weeks |
|
| Placebo | Placebo Comparator | placebo titrated to 2 pills twice daily for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | 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 | from week 9 to week 48 |
| Measure | Description | 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 | from week 9 to week 12 | |
| Change in Lung capacity (FEV1 and FVC) between inclusion and week 48 | week 48 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Patrick MERCIE, MD | CHU de Bordeaux, F-33000 | Principal Investigator |
| Geneviève CHENE, MD, PHD | INSERM U897 | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Bordeaux | Bordeaux | 33075 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39101506 | Derived | 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. | |
| 34611902 | 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. |
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D014029 | Tobacco Use Disorder |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068580 | Varenicline |
| ID | Term |
|---|---|
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
|
| 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 |
| 29329763 | 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. |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D011810 | Quinoxalines |