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Optimizing Tobacco Use Treatment for PLWHA

Study acronym: HTO
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Sponsor changed: University of Pennsylvania to Abramson Cancer Center at Penn Medicine Collaborators: 2 to 3v15 Show 1 more changeShow less
    • Collaborators: 2 to 3

    See this version in full on ClinicalTrials.gov ↗

  2. Trial status: Recruiting to Active, Not Recruiting Primary and study completion dates: Aug 31, 2026 to Nov 30, 2026 · Site details revised at 2 of 2 sitesv14 Show 2 more changesShow less
    • Primary and study completion dates: Aug 31, 2026 to Nov 30, 2026
    • Site details revised at 2 of 2 sites
  3. Primary and study completion dates: Aug 31, 2025 to Aug 31, 2026 Site contacts updated at 2 of 2 sitesv13 Show 1 more changeShow less
    • Site contacts updated at 2 of 2 sites
  4. Primary completion date: Dec 31, 2024 to Aug 31, 2025 Completion date: Jun 30, 2025 to Aug 31, 2025 · Site contacts updated at 2 of 2 sitesv12 Show 2 more changesShow less
    • Completion date: Jun 30, 2025 to Aug 31, 2025
    • Site contacts updated at 2 of 2 sites
  5. Re-verified, no change to tracked fieldsv11
Show 9 earlier versionsHide 9 earlier versions
  1. Enrollment target: 488 to 340 Study arms: 4 to 2 · Eligibility criteria shortened, about 2 wordsv10 Show 2 more changesShow less
    • Study arms: 4 to 2
    • Eligibility criteria shortened, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  2. Primary completion date: Dec 2024 to Dec 31, 2024 Completion date: Jun 2025 to Jun 30, 2025v9 Show 1 more changeShow less
    • Completion date: Jun 2025 to Jun 30, 2025
  3. Primary completion date: Dec 2023 to Dec 2024 Completion date: Jun 2024 to Jun 2025 · Eligibility criteria shortened, about 58 wordsv8 Show 2 more changesShow less
    • Completion date: Jun 2024 to Jun 2025
    • Eligibility criteria shortened, about 58 words

    See this version in full on ClinicalTrials.gov ↗

  4. Re-verified, no change to tracked fieldsv7
  5. Trial status: Active, Not Recruiting to Recruiting Enrollment target: 1 to 488 · Site details revised at 2 of 2 sitesv6 Show 2 more changesShow less
    • Enrollment target: 1 to 488
    • Site details revised at 2 of 2 sites
  6. Enrollment target: estimated 488 to confirmed 1 Trial status: Recruiting to Active, Not Recruiting · Site details revised at 2 of 2 sitesv5 Show 2 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 2 of 2 sites
  7. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 2 · Start date changed from estimate of Jan 2020 to Feb 17, 2020v4 Show 2 more changesShow less
    • Study sites: 0 to 2
    • Start date changed from estimate of Jan 2020 to Feb 17, 2020
  8. Re-verified, no change to tracked fieldsv3
  9. Study description expanded, about 1 wordv2 See this version in full on ClinicalTrials.gov ↗
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The advent of anti-retroviral therapy (ART) for people living with HIV/AIDS (PLWHA) substantially improved life expectancy but has also led to the critical need to address modifiable risk factors associated with cancer and cardiovascular disease, such as tobacco smoking. HIV-infected smokers lose more life-years due to tobacco use than they do to their HIV infection. There have been relatively few studies of tobacco use treatments for PLWHA and systematic reviews show that there are insufficient data to conclude that tobacco dependence interventions that are efficacious in the general population are efficacious for PLWHA. Further, many studies in this area have lacked randomization and a control group, infrequently used an intent-to-treat (ITT) approach and biological verification of tobacco abstinence, and lacked post-treatment follow-up.10 What investigators do know thus far is that behavioral interventions and the nicotine patch yield moderate effects on cessation; and 2 recent placebo-controlled trials - one in France and one by this lab - found that varenicline is safe and effective for treating tobacco use among PLWHA, but yield quit rates that are substantially lower than those reported in the general population. Thus, there is a critical need to rigorously test novel ways to optimize tobacco cessation treatment for smokers with HIV.
Trial Details
NCT Number NCT04176172
Lead Sponsor Abramson Cancer Center at Penn Medicine
Collaborators: National Cancer Institute (NCI), Northwestern University, University of Pennsylvania
Conditions HIV/AIDS, Nicotine Dependence
Enrollment 340 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov