Phase 3 HIV and AIDS Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- Adults aged 18 or older
- People who have a confirmed HIV diagnosis
- People who currently smoke or use tobacco in more than one form, confirmed by a breath test showing carbon monoxide levels of 7 ppm or higher, or a positive cotinine test (a test that detects a substance left in the body after using tobacco)
- People who can read at a Year 6 level or above and speak Tamil, Telugu, or English
- People whose primary doctor at VHS (Voluntary Health Services) has assessed that the study medication, varenicline, is safe for them to take
- Women who could become pregnant and agree to use a medically approved form of contraception, or to avoid sexual intercourse, while taking the study medication and for one month after finishing it
- People who are ready to quit smoking or interested in quitting
Who may not be able to join:
- People who are pregnant or planning to become pregnant within the next 6 months
- People who are currently breastfeeding
- People who have had a heart attack in the past 30 days, or who have unstable chest pain (confirm with trial site)
- People with a history of liver or kidney failure
- People whose recent blood test results (within the past 6 months) show certain liver markers more than twice the normal level, or reduced kidney function below a certain threshold (confirm with trial site for specific values)
- People with a history of a suicide attempt
- People who are currently experiencing thoughts of suicide
- People with major depression that is untreated or not currently stable
- People with a history of psychosis, or who are currently taking antipsychotic medications
- People whose thinking or memory difficulties may prevent them from being able to give informed consent to join the trial
- People who are allergic to varenicline (the study medication)
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Gina Kruse, MD, University of Colorado, Denver
Phone: 303-724-4811
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
7-Day Point Prevalent Abstinence Rate
Can't join this trial?
Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.