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NCT05873738 Clinical Trial

Smoking Cessation in a Cohort HIV+ Rio de Janeiro, Brazil.

Smoking Cessation Clinical Trial

Official title:
Smoking Cessation is Associated With Short-term Improvement of Vascular Health in a Cohort of People Living With HIV in Rio de Janeiro, Brazil.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05873738
Other study ID # 3.171.692
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 10, 2019
Est. completion date April 15, 2023

Study information
Verified date May 2023
Source Instituto Fernandes Figueira
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 115
Est. completion date April 15, 2023
Est. primary completion date April 15, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Nicotine replacement
Nicotine patches

Locations
Country Name City State
Brazil Instituto Nacional de Infectologia Evandro Chagas Rio de Janeiro

Sponsors (1)
Lead Sponsor Collaborator
Instituto Fernandes Figueira

Country where clinical trial is conducted

Brazil, 

Outcome
Type Measure Description Time frame Safety issue
Primary FMD Flow mediated brachial artery dilatation 12 months
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