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Efficacy, Safety and Tolerability Study of Long-acting Cabotegravir Plus Long-acting Rilpivirine (CAB LA + RPV LA) in Human-immunodeficiency Virus-1 (HIV-1) Infected Adults

Study acronym: ATLAS-2M
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 68 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Completion date: Dec 31, 2025 to Dec 31, 2029v68
  2. Study sites: 120 to 118 Completion date: Dec 31, 2026 to Dec 31, 2025v67 Show 1 more changeShow less
    • Completion date: Dec 31, 2026 to Dec 31, 2025
  3. Publications: 7 to 8v66 See this version in full on ClinicalTrials.gov ↗
  4. Completion date: Feb 7, 2024 to Dec 31, 2026v65
  5. Site details revised at 22 of 120 sitesv64
Show 45 earlier versionsHide 45 earlier versions
  1. 4 versions Re-verified since Oct 18, 2022, no change to tracked fieldsv60-v63
  2. Eligibility criteria expanded, about 185 wordsv59 See this version in full on ClinicalTrials.gov ↗
  3. Site details revised at 1 of 120 sitesv58
  4. 2 versions Re-verified since Apr 28, 2022, no change to tracked fieldsv56-v57
  5. Study sites: 119 to 120 Completion date: Feb 9, 2024 to Feb 7, 2024v55 Show 1 more changeShow less
    • Completion date: Feb 9, 2024 to Feb 7, 2024
  6. Completion date: Mar 14, 2022 to Feb 9, 2024 Site details revised at 3 of 119 sites · Publications: details revised at 1 of 7 entriesv54 Show 2 more changesShow less
    • Site details revised at 3 of 119 sites
    • Publications: details revised at 1 of 7 entries
  7. Results first posted: Jun 11, 2020 Primary endpoint revised · Completion date: Mar 11, 2022 to Mar 14, 2022 · Secondary endpoints: 47 to 45 · 1 morev53 Show 4 more changesShow less
    • Primary endpoint revised
    • Completion date: Mar 11, 2022 to Mar 14, 2022
    • Secondary endpoints: 47 to 45
    • Site details revised at 1 of 119 sites

    See this version in full on ClinicalTrials.gov ↗

  8. Site details revised at 1 of 119 sitesv52
  9. Enrollment target: estimated 1020 to confirmed 1049 Site details revised at 3 of 119 sitesv51 Show 1 more changeShow less
    • Site details revised at 3 of 119 sites
  10. Primary completion date: May 31, 2019 to Jun 6, 2019 Completion date: Mar 7, 2022 to Mar 11, 2022v50 Show 1 more changeShow less
    • Completion date: Mar 7, 2022 to Mar 11, 2022
  11. Eligibility criteria expanded, about 21 words Secondary endpoints: 45 to 47v49 Show 1 more changeShow less
    • Secondary endpoints: 45 to 47

    See this version in full on ClinicalTrials.gov ↗

  12. Site details revised at 10 of 119 sitesv48
  13. Site details revised at 10 of 119 sitesv47
  14. Re-verified, no change to tracked fieldsv46
  15. Start date: Apr 18, 2017 to Oct 27, 2017 Study sites: 118 to 119v45 Show 1 more changeShow less
    • Study sites: 118 to 119
  16. Trial status: Recruiting to Active, Not Recruiting Site details revised at 118 of 118 sitesv44 Show 1 more changeShow less
    • Site details revised at 118 of 118 sites
  17. Site details revised at 1 of 118 sitesv43
  18. Study sites: 113 to 118v42
  19. Start date: Oct 27, 2017 to Apr 18, 2017v41
  20. Site details revised at 1 of 113 sitesv40
  21. Site details revised at 3 of 113 sitesv39
  22. Study sites: 112 to 113v38
  23. Study sites: 113 to 112v37
  24. Site details revised at 5 of 113 sitesv36
  25. Study sites: 112 to 113v35
  26. Study sites: 111 to 112v34
  27. Study sites: 110 to 111v33
  28. Start date: Mar 6, 2017 to Oct 27, 2017 Study sites: 109 to 110v32 Show 1 more changeShow less
    • Study sites: 109 to 110
  29. Study sites: 104 to 109v31
  30. Study sites: 103 to 104 Start date: Oct 27, 2017 to Mar 6, 2017v30 Show 1 more changeShow less
    • Start date: Oct 27, 2017 to Mar 6, 2017
  31. Study sites: 101 to 103v29
  32. Site details revised at 7 of 101 sitesv28
  33. Study sites: 100 to 101v27
  34. Study sites: 98 to 100v26
  35. Study sites: 89 to 98v25
  36. Study sites: 84 to 89v24
  37. Study sites: 83 to 84v23
  38. Study sites: 80 to 83v22
  39. Study sites: 76 to 80v21
  40. Start date: Jan 8, 2017 to Oct 27, 2017 Study sites: 67 to 76v20 Show 1 more changeShow less
    • Study sites: 67 to 76
  41. Study sites: 54 to 67v19
  • 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.
This Antiretroviral Therapy as Long Acting Suppression every 2 Months (ATLAS-2M) study is designed to demonstrate the non-inferior antiviral activity and safety of CAB LA + RPV LA administered every 8 weeks (Q8W) compared to CAB LA + RPV LA administered every 4 weeks (Q4W) over a 48-week treatment period in approximately 1020 adult HIV-1 infected subjects. Subjects will be divided in 2 groups; Group 1 will include subjects receiving current anti-retroviral (ART) standard of care (SOC) therapy whereas group 2 will include subjects currently receiving CAB LA + RPV LA Q4W in ATLAS study. Subjects in both groups will be randomized to receive CAB LA + RPV LA Q4W or Q8W. The study will be carried out in 3 phases including screening phase, maintenance phase and extension phase. Subjects choosing not to enter the Extension phase can complete their study participation at the Week 100 visit and enter into the 52-week Long-Term Follow-Up (LTFU) Phase as required. A sub-study in the ATLAS-2M study will evaluate the pharmacokinetics, tolerability and efficacy of CAB and RPV long acting injections following intramuscular administration in the Vastus Lateralis Muscle (thigh) in HIV-infected Adult Participants who have received at least three years of Gluteal Injections in this ATLAS-2M Study.
Trial Details
NCT Number NCT03299049
Lead Sponsor ViiV Healthcare
Collaborators: Janssen Research & Development, LLC
Conditions HIV Infections
Enrollment 1,049 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov