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NCT01710137 · ClinicalTrials.gov registry record · Phase 3
Varenicline for Nicotine Dependence Among Those With HIV/AIDS
A Phase 3 study, sponsored by University of Pennsylvania.
- Completed
- Registry status
- Phase 3
- Development phase
- 179
- Enrollment target
NCT01710137: Completed Phase 3 study, sponsored by University of Pennsylvania.
NCT01710137 is a Phase 3 study that has completed, run by University of Pennsylvania. The registered enrollment target is 179 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01710137, a Phase 3 study, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 179 participants
- Enrollment target
Study Summary
Among people diagnosed with HIV/AIDS, the widespread use of highly active antiretroviral therapy (HAART) has greatly improved survival rates and changed the leading causes of death, from AIDS-related diseases to cardiovascular disease and lung cancer. Rates of tobacco use among individuals with HIV/AIDS are very high and varenicline may be particularly efficacious for treating nicotine dependence among individuals with HIV/AIDS. Through this trial, 310 smokers with HIV/AIDS will be randomized to varenicline plus 9 weeks of smoking cessation counseling or placebo plus 9 weeks of smoking cessation counseling. The investigators hypothesize that 1) varenicline and counseling will significantly increase end-of-treatment (week 12) and 24-week biochemically-confirmed abstinence, versus placebo and counseling; 2) quality of life will be rated higher in the varenicline and counseling group versus the placebo and counseling group, and there will be no significant differences between treatment arms in terms of the frequency of severe varenicline-related side effects; and 3) improved affect and reduced cognitive impairment will mediate the effect of varenicline therapy on quit rates.
Primary Outcome
7-day biochemically-confirmed tobacco abstinence; biochemically-confirmed with urine cotinine.
Interventions
- DRUG Placebo
- DRUG Varenicline
- BEHAVIORAL Smoking Cessation Counseling
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 179 participants |
| Start Date | 2012-10 |
| Est. Completion | 2018-09 |
| Phase | Phase 3 |
What the finished NCT01710137 record still lists
NCT01710137 is an interventional study that assigns participants to a tested intervention. The registered 179 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01710137 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01710137 about?
NCT01710137 is a clinical study titled "Varenicline for Nicotine Dependence Among Those With HIV/AIDS". Among people diagnosed with HIV/AIDS, the widespread use of highly active antiretroviral therapy (HAART) has greatly improved survival rates and changed the leading causes of death, from AIDS-related diseases to cardiovascular disease and lung cancer. Rates of tobacco use among individuals with HIV/...
What is the current status of trial NCT01710137?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 179 participants. The study started on 2012-10. Estimated completion is 2018-09.
What interventions are being tested in trial NCT01710137?
The interventions under investigation include: Placebo (DRUG), Varenicline (DRUG), Smoking Cessation Counseling (BEHAVIORAL).
Who is sponsoring clinical trial NCT01710137?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01710137's enrollment target sits among peer trials
179 1437th of 2000 higher than 564 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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