NCT05873738CompletedNot Applicable
Smoking Cessation is Associated With Short-term Improvement of Vascular Health in a Cohort of People Living With HIV in Rio de Janeiro, Brazil.
Instituto Fernandes Figueira1 site in 1 country115 target enrollmentStarted: December 10, 2019Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Instituto Fernandes Figueira
- Enrollment
- 115
- Locations
- 1
- Primary Endpoint
- FMD
Study Overview
Brief Summary
The study was carried out within a large, urban prospective cohort of PLHIV at the Instituto Nacional de Infectologia Evandro Chagas (INI). Located in Rio de Janeiro, Brazil, INI is a national public referral center for PLWHA receiving primary care since 1998. From December 2019, adults who had attitudes toward quitting smoking and had no contraindications to study pharmacotherapy were enrolled by active site searching
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •individuals were deemed as regular smokers, defined as the consumption of one or more pack (20 cigarettes) per week in the past 6 months, and expired carbon monoxide (CO) measurement > 10 ppm at the screening visit.
Exclusion Criteria
- •previous use of transdermal nicotine patches or bupropion in the last 6 months; (ii) contraindication to nicotine patches; (iii). Pregnancy; (iv) breastfeeding
Arms & Interventions
Group 1
Relapse
Intervention: Nicotine replacement (Drug)
Group 2
Smoking cessation
Intervention: Nicotine replacement (Drug)
Outcomes
Primary Outcomes
FMD
Time Frame: 12 months
Flow mediated brachial artery dilatation
Secondary Outcomes
No secondary outcomes reported
Investigators
Rodrigo de Carvalho Moreira
Dr
Oswaldo Cruz Foundation
Study Sites (1)
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