NCT00701896

Brief Summary

People that are infected with HIV appear to be especially susceptible to the adverse effects of cigarette smoking. The purpose of this study is to determine if quitting smoking by using a specialized smoking cessation treatment can prevent one from developing accelerated lung damage, particularly emphysema.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
294

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 19, 2008

Completed
4 months until next milestone

Study Start

First participant enrolled

October 3, 2008

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2013

Completed
7.6 years until next milestone

Results Posted

Study results publicly available

January 15, 2021

Completed
Last Updated

January 15, 2021

Status Verified

December 1, 2020

Enrollment Period

4.5 years

First QC Date

June 17, 2008

Results QC Date

December 18, 2020

Last Update Submit

December 18, 2020

Conditions

SmokingHIV Infections

Keywords

HIVPositiveSmokersVarenicline

Outcome Measures

Primary Outcomes (1)

  • To Determine the Safety of Varenicline in PLWH Who Smoke

    To determine the safety and tolerability of varenicline compared to nicotine replacement

    3 months

Secondary Outcomes (1)

  • To Determine the Efficacy of Varenicline for Smoking Cessation Among PLWH Who Smoke

    12 months

Study Arms (4)

Healthy Control - Non-smoking

OTHER

Healthy Control arm with 51 subjects who are HIV negative and do not smoke

Other: Biological Control

Healthy Control - Smoker

OTHER

Healthy Control arm, includes 50 subjects who are HIV negative and are smokers.

Other: Biological Control

HIV Smoking Cessation Arm

ACTIVE COMPARATOR

Includes up to 365 subjects who are HIV positive and initiate smoking cessation

Drug: Varenicline tartrateDrug: Nicotine Replacement Therapy

Motivational Intervention

EXPERIMENTAL

Includes up to 100 subjects who are HIV positive, do not wish to quit smoking but are willing to undergo one-on-one Motivational Intervention

Behavioral: Motivational Interview

Interventions

Varenicline tartrateDRUG

1 mMg tablet form; daily during week 1 (pre-quit week) followed by 1 mg twice daily for weeks 2-12.

Also known as: Chantix
HIV Smoking Cessation Arm
Nicotine Replacement TherapyDRUG

Nicotine gum and nicotine patch

HIV Smoking Cessation Arm
Biological ControlOTHER

No treatment intervention only information and procedures.

Healthy Control - Non-smokingHealthy Control - Smoker
Motivational InterviewBEHAVIORAL

60 minute one-on-one Interview

Motivational Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age and older;
  • diagnosis of HIV;
  • self-reported smoking on a daily basis;
  • provide informed written consent

You may not qualify if:

  • persons with active psychosis or impaired mental status as judged by the clinic staff and confirmed with a Mini-Mental Status Exam)
  • unable to understand spoken English
  • age less than 18 years.
  • pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Related Publications (1)

  • Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.

    PMID: 37142273DERIVED

MeSH Terms

Conditions

SmokingHIV Infections

Interventions

VareniclineNicotine Replacement TherapyMotivational Interviewing

Condition Hierarchy (Ancestors)

BehaviorBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

BenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsQuinoxalinesDrug TherapyTherapeuticsDirective CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Results Point of Contact

Title
Dr. Philip Diaz
Organization
Ohio State University
diaz.3@osu.edu
6142934925

Study Officials

  • Philip T. Diaz, MD

    Ohio State University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director, Pulmonary Rehabilitation Services; Medical Director, Respiratory Therapy; Associate Director, General Clinical Research Center

Study Record Dates

First Submitted

June 17, 2008

First Posted

June 19, 2008

Study Start

October 3, 2008

Primary Completion

April 20, 2013

Study Completion

June 20, 2013

Last Updated

January 15, 2021

Results First Posted

January 15, 2021

Record last verified: 2020-12

Locations

US(1)