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New study aims to help smokers with HIV kick the habit for good

NCT ID NCT04176172

Disease control Sponsor: Abramson Cancer Center at Penn Medicine Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 1 time

Summary

This study tests whether a smoking cessation medication (varenicline) combined with tools to help people stick with treatment can improve quit rates for smokers living with HIV. About 340 participants will be followed for 6 months to see if they stop smoking, confirmed by breath tests. The goal is to reduce the high risk of cancer and heart disease in this group.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 340 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2020

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: * \>18 years, smoke daily for the past 30 days * Confirmed HIV+ (exhibit viral load of \<1000 copies/mL) * Residing in the geographic area close to one of the sites for at least 7 months * Able to use varenicline/TN patch safely Key Exclusion Criteria: * Current untreated and unstable diagnosis of substance abuse/dependence * Current diagnosis of unstable and untreated major depression, psychosis or bipolar disorder * Suicide risk as measured by the C-SSRS * Current use or discontinuation within last 14 days of quit smoking medications * Cancer, heart disease, stroke or MI within the past 6 months requires study physician approval * Uncontrolled hypertension * History of epilepsy or seizure disorder requires study physician approval * Women who are pregnant, planning a pregnancy, or lactating * Use of e-cigarettes, chewing tobacco, snuff or snus * Generalized eczema or psoriasis * A reaction or sensitivity to a nicotine patch or any other transdermal medication requires study physician approval * Currently participating in a smoking cessation program

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Conditions

The condition(s) this trial relates to.

AIDS Cigarette Smoking HIV infectious disease nicotine dependence Smoking Cessation

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HIV/AIDS Nicotine dependence

Contacts and locations

Locations

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

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