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The LATITUDE Study: Long-Acting Therapy to Improve Treatment SUccess in Daily LifE

StatusCompleted
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 65 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Trial completed Study completion date changed from estimate of Aug 30, 2026 to Aug 17, 2026 · Secondary endpoints: details revised at 17 of 19 entries · Site details revised at 3 of 33 sites · 1 more Show 4 more changesShow less
    • Study completion date changed from estimate of Aug 30, 2026 to Aug 17, 2026
    • Secondary endpoints: details revised at 17 of 19 entries
    • Site details revised at 3 of 33 sites
    • Eligibility criteria expanded, about 4 words
  2. Re-verified, no change to tracked fieldsv64
  3. Study sites: 31 to 33v63
  4. Results first posted: Apr 24, 2025v62
  5. Enrollment target: 308 to 456 Secondary endpoints revised (19) · Study description shortened, about 13 wordsv61 Show 2 more changesShow less
    • Secondary endpoints revised (19)
    • Study description shortened, about 13 words

    See this version in full on ClinicalTrials.gov ↗

Show 45 earlier versionsHide 45 earlier versions
  1. Primary endpoint revised Enrollment target: 310 to 308 · Primary completion date: Oct 15, 2024 to Feb 12, 2024 · Eligibility criteria expanded, about 14 words · 3 morev60 Show 6 more changesShow less
    • Enrollment target: 310 to 308
    • Primary completion date: Oct 15, 2024 to Feb 12, 2024
    • Eligibility criteria expanded, about 14 words
    • Secondary endpoints: 12 to 19
    • Study description expanded, about 608 words
    • Study arms: 2 to 3

    See this version in full on ClinicalTrials.gov ↗

  2. Primary completion date changed from estimate of Nov 15, 2024 to Oct 15, 2024v59
  3. Primary completion date: Oct 15, 2024 to Nov 15, 2024v58
  4. Re-verified, no change to tracked fieldsv57
  5. Primary completion date: Sep 30, 2024 to Oct 15, 2024v56
  6. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 350 to confirmed 310 · Study sites: 35 to 31 · Primary completion date: Jun 30, 2025 to Sep 30, 2024 · 3 morev55 Show 6 more changesShow less
    • Enrollment target: estimated 350 to confirmed 310
    • Study sites: 35 to 31
    • Primary completion date: Jun 30, 2025 to Sep 30, 2024
    • Completion date: Dec 31, 2026 to Aug 30, 2026
    • Eligibility criteria expanded, about 245 words
    • Study description expanded, about 59 words

    See this version in full on ClinicalTrials.gov ↗

  7. Site details revised at 1 of 35 sitesv54
  8. Primary completion date: Nov 30, 2024 to Jun 30, 2025v53
  9. Site details revised at 1 of 35 sitesv52
  10. Eligibility criteria expanded, about 133 words Secondary endpoints: 13 to 12 · Site details revised at 2 of 35 sitesv51 Show 2 more changesShow less
    • Secondary endpoints: 13 to 12
    • Site details revised at 2 of 35 sites

    See this version in full on ClinicalTrials.gov ↗

  11. Primary completion date: Oct 1, 2023 to Nov 30, 2024 Completion date: Oct 1, 2025 to Dec 31, 2026v50 Show 1 more changeShow less
    • Completion date: Oct 1, 2025 to Dec 31, 2026
  12. Re-verified, no change to tracked fieldsv49
  13. Site details revised at 1 of 35 sitesv48
  14. 2 versions Re-verified since Oct 15, 2021, no change to tracked fieldsv46-v47
  15. Site details revised at 1 of 35 sites Collaborator revisedv45 Show 1 more changeShow less
    • Collaborator revised

    See this version in full on ClinicalTrials.gov ↗

  16. Re-verified, no change to tracked fieldsv44
  17. Trial status: Active, Not Recruiting to Recruiting Site details revised at 35 of 35 sitesv43 Show 1 more changeShow less
    • Site details revised at 35 of 35 sites
  18. Primary completion date: Sep 1, 2022 to Oct 1, 2023 Completion date: Sep 26, 2024 to Oct 1, 2025v42 Show 1 more changeShow less
    • Completion date: Sep 26, 2024 to Oct 1, 2025
  19. Trial status: Recruiting to Active, Not Recruiting Site details revised at 35 of 35 sitesv41 Show 1 more changeShow less
    • Site details revised at 35 of 35 sites
  20. Site contacts updated at 2 of 35 sitesv40
  21. Site contacts updated at 1 of 35 sitesv39
  22. Site contacts updated at 1 of 35 sitesv38
  23. Site contacts updated at 2 of 35 sitesv37
  24. Study Status, Eligibilityv36
  25. Site contacts updated at 1 of 35 sitesv35
  26. Study Status, Sponsor/Collaboratorsv34
  27. Re-verified, no change to tracked fieldsv33
  28. Site contacts updated at 1 of 35 sitesv32
  29. Study sites: 34 to 35v31
  30. Study sites: 33 to 34v30
  31. Study sites: 32 to 33v29
  32. Study sites: 31 to 32v28
  33. Study sites: 30 to 31v27
  34. Trial status: Not Yet Recruiting to Recruiting Primary completion date: Oct 18, 2021 to Sep 1, 2022 · Completion date: Sep 7, 2024 to Sep 26, 2024 · Start date changed from estimate of Mar 27, 2019 to Mar 28, 2019 · 1 morev26 Show 4 more changesShow less
    • Primary completion date: Oct 18, 2021 to Sep 1, 2022
    • Completion date: Sep 7, 2024 to Sep 26, 2024
    • Start date changed from estimate of Mar 27, 2019 to Mar 28, 2019
    • Site details revised at 30 of 30 sites
  35. Study sites: 29 to 30 Completion date: Aug 10, 2024 to Sep 7, 2024v25 Show 1 more changeShow less
    • Completion date: Aug 10, 2024 to Sep 7, 2024
  36. Start date: Feb 27, 2019 to Mar 27, 2019v24
  37. Study sites: 28 to 29v23
  38. Study sites: 27 to 28 Completion date: Jul 25, 2024 to Aug 10, 2024 · Start date: Feb 11, 2019 to Feb 27, 2019v22 Show 2 more changesShow less
    • Completion date: Jul 25, 2024 to Aug 10, 2024
    • Start date: Feb 11, 2019 to Feb 27, 2019
  39. Study title expanded, about 4 wordsv21 See this version in full on ClinicalTrials.gov ↗
  40. Study sites: 26 to 27 Completion date: Jun 22, 2024 to Jul 25, 2024v20 Show 1 more changeShow less
    • Completion date: Jun 22, 2024 to Jul 25, 2024
  41. Start date: Jan 9, 2019 to Feb 11, 2019v19
  42. Study sites: 24 to 26v18
  43. Study sites: 23 to 24v17
  44. Start date: Dec 10, 2018 to Jan 9, 2019 Study sites: 21 to 23 · Completion date: May 23, 2024 to Jun 22, 2024v16 Show 2 more changesShow less
    • Study sites: 21 to 23
    • Completion date: May 23, 2024 to Jun 22, 2024
  • 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 purpose of this study was to compare the efficacy, safety, and durability of two different strategies to treat participants with a history of sub-optimal adherence and control of their HIV infection: long-acting (LA) antiretroviral therapy (ART) and all-oral standard of care (SOC).
Trial Details
NCT Number NCT03635788
Lead Sponsor National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators: ViiV Healthcare
Conditions HIV Infections
Enrollment 456 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov