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Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Long-acting Cabotegravir Plus Long-acting Rilpivirine From Current Antiretroviral Regimen in Virologically Suppressed HIV-1-infected Adults

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 69 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Site details revised at 2 of 113 sitesv69
  2. Completion date: Dec 31, 2025 to Dec 31, 2029v68
  3. Study sites: 115 to 113 Completion date: Dec 31, 2026 to Dec 31, 2025v67 Show 1 more changeShow less
    • Completion date: Dec 31, 2026 to Dec 31, 2025
  4. Re-verified, no change to tracked fieldsv66
  5. Completion date: Feb 8, 2024 to Dec 31, 2026v65
Show 45 earlier versionsHide 45 earlier versions
  1. Re-verified, no change to tracked fieldsv64
  2. Site details revised at 1 of 115 sitesv63
  3. 2 versions Re-verified since Apr 28, 2022, no change to tracked fieldsv61-v62
  4. Site details revised at 6 of 115 sitesv60
  5. Publications: 6 to 7v59 See this version in full on ClinicalTrials.gov ↗
  6. Completion date: Feb 8, 2022 to Feb 8, 2024 Site details revised at 2 of 115 sitesv58 Show 1 more changeShow less
    • Site details revised at 2 of 115 sites
  7. Re-verified, no change to tracked fieldsv57
  8. Publications: details revised at 1 of 6 entriesv56
  9. Re-verified, no change to tracked fieldsv55
  10. Secondary endpoints: 84 to 83v54 See this version in full on ClinicalTrials.gov ↗
  11. Secondary endpoints: 83 to 84 Site details revised at 1 of 115 sitesv53 Show 1 more changeShow less
    • Site details revised at 1 of 115 sites

    See this version in full on ClinicalTrials.gov ↗

  12. Re-verified, no change to tracked fieldsv52
  13. Results first posted: Jun 13, 2019 Primary endpoint revised · Study sites: 119 to 115 · Secondary endpoints: 50 to 83v51 Show 3 more changesShow less
    • Primary endpoint revised
    • Study sites: 119 to 115
    • Secondary endpoints: 50 to 83

    See this version in full on ClinicalTrials.gov ↗

  14. 3 versions Re-verified since Sep 24, 2018, no change to tracked fieldsv48-v50
  15. Primary endpoint revised Enrollment target: estimated 570 to confirmed 618 · Completion date: Feb 16, 2022 to Feb 8, 2022 · Eligibility criteria expanded, about 96 words · 2 morev47 Show 5 more changesShow less
    • Enrollment target: estimated 570 to confirmed 618
    • Completion date: Feb 16, 2022 to Feb 8, 2022
    • Eligibility criteria expanded, about 96 words
    • Secondary endpoints: 32 to 50
    • Site details revised at 3 of 119 sites

    See this version in full on ClinicalTrials.gov ↗

  16. Primary completion date: Jun 5, 2018 to May 29, 2018v46
  17. 9 versions Re-verified since Apr 2, 2018, no change to tracked fieldsv37-v45
  18. Site details revised at 1 of 119 sitesv36
  19. 2 versions Re-verified since Jan 25, 2018, no change to tracked fieldsv34-v35
  20. Primary completion date: May 23, 2018 to Jun 5, 2018 Completion date: Feb 3, 2022 to Feb 16, 2022 · Site details revised at 1 of 119 sitesv33 Show 2 more changesShow less
    • Completion date: Feb 3, 2022 to Feb 16, 2022
    • Site details revised at 1 of 119 sites
  21. Site details revised at 1 of 119 sitesv32
  22. Re-verified, no change to tracked fieldsv31
  23. Trial status: Recruiting to Active, Not Recruiting Study sites: 118 to 119 · Primary completion date: Jul 13, 2018 to May 23, 2018 · Completion date: Mar 28, 2022 to Feb 3, 2022v30 Show 3 more changesShow less
    • Study sites: 118 to 119
    • Primary completion date: Jul 13, 2018 to May 23, 2018
    • Completion date: Mar 28, 2022 to Feb 3, 2022
  24. Study sites: 117 to 118v29
  25. Study sites: 115 to 117v28
  26. Site details revised at 1 of 115 sitesv27
  27. Site details revised at 3 of 115 sitesv26
  28. Study sites: 113 to 115v25
  29. Study sites: 112 to 113v24
  30. Study sites: 111 to 112v23
  31. Site details revised at 1 of 111 sitesv22
  32. Study sites: 110 to 111v21
  33. Study sites: 109 to 110 Primary completion date: Jul 2018 to Jul 13, 2018 · Completion date: Mar 2022 to Mar 28, 2022 · Start date: Oct 2016 to Oct 28, 2016v20 Show 3 more changesShow less
    • Primary completion date: Jul 2018 to Jul 13, 2018
    • Completion date: Mar 2022 to Mar 28, 2022
    • Start date: Oct 2016 to Oct 28, 2016
  • 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 Antiretroviral Therapy as Long Acting Suppression (ATLAS) study is being conducted to establish if human immunodeficiency virus type-1 (HIV-1) infected adult subjects with current viral suppression on a regimen with 2 nucleoside reverse transcriptase inhibitors (NRTIs) plus a third agent, remain suppressed upon switching to a two-drug intramuscular (IM) long-acting (LA) regimen of cabotegravir (CAB) and rilpivirine (RPV). This is a Phase 3, multi-phase, randomized, open label, active-controlled, multicenter, parallel-group, non-inferiority study in HIV-1, antiretroviral therapy (ART)-adult subjects who are stably suppressed on a current antiretroviral (ARV) regimen. This study is designed to demonstrate the non-inferior antiviral activity of switching to a two drug CAB LA 400 mg + RPV LA 600 mg regimen every 4 weeks (Q4W: monthly) compared with maintenance of current ARV regimen containing 2 NRTIs plus an INI, NNRTI, or a PI. Eligible subjects will be randomized (1:1) into the Maintenance Phase at Day 1 to either continue current ART or switch to initiate oral therapy with CAB 30 mg + RPV 25 mg once daily for 4 Weeks followed by Q4 weekly (monthly) CAB LA + RPV LA injections. Following the Maintenance phase at Week 52, subjects who were randomized to continue their current ART regimen will be given an option to switch to CAB LA + RPV LA injections. Those subjects would transition to LA dosing, beginning with 4 weeks oral CAB + RPV therapy at Week 52, and receive the first IM CAB LA + RPV LA injections at Week 56.
Trial Details
NCT Number NCT02951052
Lead Sponsor ViiV Healthcare
Collaborators: Janssen Pharmaceuticals, GlaxoSmithKline
Conditions Infection, Human Immunodeficiency Virus, HIV Infections
Enrollment 618 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov