Phase 3 HIV and AIDS Trial, Recruiting NCT05413122 Sponsor: Johns Hopkins University Condition: HIV and AIDS
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Phase 3 HIV and AIDS Trial, Recruiting

NCT05413122
Recruiting Phase 3

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:

  • People who are 18 years of age or older
  • People who attend one of the clinics selected for this study
  • People who have a confirmed HIV diagnosis, shown by a prescription for HIV combination treatment or a medication pack with their name on it
  • People who have been taking HIV combination treatment for at least three months in a row, or for at least four of the past six months
  • People who are current tobacco smokers — meaning they have smoked at least 100 cigarettes in their lifetime, have smoked at least one cigarette per day in the past 30 days, and have test results (a breath test and a urine test) confirming active smoking
  • People who own a mobile phone or live in a household where one is available
  • People who are willing and able to provide written consent to participate

Who may not be able to join:

  • People who have used any stop-smoking counselling or medication in the past 14 days
  • People whose overall health is too poor to participate, as assessed by the treating doctor using a standard health scoring tool
  • People who have a history of seizures, cancer, heart disease, stroke, heart attack, stomach ulcers, kidney failure, or liver failure
  • People who have widespread eczema or psoriasis
  • People who have been assessed as having significant cognitive difficulties or psychosis, using a specific psychiatric assessment tool
  • People who have been assessed as being at risk of suicide, using a specific rating scale
  • People who are pregnant, planning to become pregnant in the next four months, currently breastfeeding, or unwilling to use effective contraception
  • People who have previously had a bad reaction to varenicline or nicotine patches
  • People who do not plan to continue receiving care at the study clinic for the next 52 weeks
  • People who live in the same household as someone already enrolled in this trial
  • People whom the attending doctor considers unsuitable for the trial for any other reason

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.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 22 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Neil Martison, Perinatal HIV Research Unit (PHRU)

Phone: 443-287-2969

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

Status
Recruiting
Phase
Phase 3
Registry
ClinicalTrials.gov
Start date
27 November 2023
Est. completion
31 August 2027

Where this trial is recruiting

🇿🇦 South Africa

Primary endpoints

7-day point prevalence tobacco abstinence at 52 weeks

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 22 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov