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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. 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01710137
The ClinicalTrials.gov registry entry for NCT01710137 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 179 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pennsylvania, which has 1,423 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01710137 reports 0 study locations.
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.
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