CClinicalTrials.gg
CompletedNCT05873738Updated May 24, 2023

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

An observational study in Smoking Cessation, Brachial Flow Mediated Dilatation and Nicotine Replacement Therapy, sponsored by Instituto Fernandes Figueira. Completed at 1 site in Brazil. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-24.

Sponsored by Instituto Fernandes Figueira · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
115
Ages
18 Years and older
Sex
All
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Study 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

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Conditions studied

  • Smoking Cessation
  • Brachial Flow Mediated Dilatation
  • Nicotine Replacement Therapy
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In context

Dilatation, Pathologic

260 studies on the registry are indexed under Dilatation, Pathologic; 43 are open to participants now.

This study's enrollment of 115 is above the median of 94 across 64 observational studies indexed under Dilatation, Pathologic.

Browse Dilatation, Pathologic studies →

Lead sponsor

Instituto Fernandes Figueira is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Adults HIV positive who had attitudes toward quitting smoking and had no contraindications to study pharmacotherapy

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

Exclusion Criteria:

  • previous use of transdermal nicotine patches or bupropion in the last 6 months; (ii) contraindication to nicotine patches; (iii). Pregnancy; (iv) breastfeeding
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
115 participants (actual)
Patient registry
No

Groups and cohorts

  • Group 1

    Relapse

    Drug: Nicotine replacement

  • Group 2

    Smoking cessation

    Drug: Nicotine replacement

Interventions

  • DrugNicotine replacement

    Nicotine patches

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What researchers measure

Primary outcomes

  1. FMD

    Flow mediated brachial artery dilatation

    Time frame: 12 months

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Study locations

1 site
  • Instituto Nacional de Infectologia Evandro Chagas
    Rio de Janeiro, 22210-080, Brazil
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References and documents

Individual participant data

Plan to share: No — Upon request data will be shared , anonimyzed

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 24, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05873738
Lead sponsor
Instituto Fernandes Figueira
Responsible party
Rodrigo de Carvalho Moreira (Dr, Oswaldo Cruz Foundation) — Principal investigator
First posted
May 24, 2023
Start date
Dec 10, 2019
Primary completion
Apr 15, 2022
Completion
Apr 15, 2023
Last update
May 24, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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