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8110 Gatehouse Road, Falls Church, VA 22042

Optimizing Smoking Cessation Treatments in Smokers Living with HIV/AIDS


General Information

Age Group




Protocol Number


Background Information

This is a research study for smoking patients living with HIV who are looking to quit smoking. The study will provide Chantix or a placebo to enrolled patients for 3 months. The study will be randomized, so the patient and study team will not know which patient will receive Chantix or the placebo. Half of the enrolled patient will also receive counseling intervention for smoking cessation, called Positively Smoke Free (PSF) program. The intervention will also be randomized and patients will not know whether they will receive the PSF intervention until the Baseline visit. This study will collect blood samples at three different time points, approximately 10 teaspoons of blood at each time point. A carbon monoxide breath test will also be conducted at each study visit. The study will last approximately 7 months; the treatment period will last approximately 3 months, with a follow up visit 3 months after the end of treatment.

Offered At

Inova Fairfax Hospital
3300 Gallows Road
Falls Church, VA 22042

Principal Investigator

Christopher deFilippi, MD

Eligibility Information

  • Confirmed chart diagnosis of HIV and receiving HIV treatment at the participating HIV clinic
  • Age 18 years or older
  • Currently self-reporting smoking, approximately 10 cigarettes per day
  • Motivation to quit smoking
  • Does not meet current DSM 5 criteria for alcohol or substance use disorder
  • Able to read and speak English
  • Willingness and ability to provide informed consent to participate

Ineligibility Information

  • Recent use of Chantix (varenicline)
  • Allergic reaction or sensitivity to Chantix (varenciline)
  • Pregnant, nursing, or plans to become pregnant during the study
  • Moderate to severe renal impairment
  • Unstable cardiovascular disease; determined by physician, chart review, and EKG
  • Score of <5ppm on carbon monoxide breath test
  • Study physician will determine overall eligibility if all eligibility criteria are met, and ineligibility criteria are not met