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DOR/ISL in HIV-1 Antiretroviral Treatment-naïve Participants (MK-8591A-053)

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

Record History

The 50 most recent of 62 record versions are listed below. See every version on ClinicalTrials.gov ↗

  1. Lead sponsor: Merck Sharp & Dohme LLC to Merck Sharp & Dohme LLC
    • Interventions: BIC/FTC/TAF (Drug), DOR/ISL (Drug), Placebo to BIC/FTC/TAF (Drug), Placebo to DOR/ISL (Drug) to BIC/FTC/TAF (Drug), DOR/ISL (Drug), Placebo to BIC/FTC/TAF (Drug), Placebo to DOR/ISL (Drug)
    • Secondary endpoints: details revised at 5 of 14 entries
    • Site details revised at 7 of 131 sites
  2. Enrollment target: estimated 500 to confirmed 537
    • Primary completion date changed from estimate of Oct 19, 2025 to Oct 13, 2025
    v61
  3. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 131 of 131 sites
    v60
  4. Study sites: 130 to 131v59
  5. Site details revised at 8 of 130 sitesv58
Show 45 earlier versionsHide 45 earlier versions
  1. Site details revised at 2 of 130 sitesv57
  2. Study sites: 129 to 130v56
  3. Study sites: 126 to 129
    • Study completion date: Nov 1, 2026 to Aug 5, 2029
    v55
  4. Study sites: 125 to 126v54
  5. Study sites: 123 to 125v53
  6. Study sites: 120 to 123v52
  7. Study sites: 118 to 120v51
  8. Study sites: 116 to 118v50
  9. Study sites: 113 to 116v49
  10. Study sites: 109 to 113v48
  11. Study sites: 105 to 109v47
  12. Study sites: 101 to 105v46
  13. Study sites: 89 to 101v45
  14. Study sites: 65 to 89v44
  15. Site details revised at 2 of 65 sitesv43
  16. Study sites: 64 to 65v42
  17. Study sites: 63 to 64v41
  18. Site contacts updated at 1 of 63 sitesv40
  19. Site details revised at 1 of 63 sitesv39
  20. Site details revised at 1 of 63 sitesv38
  21. Site contacts updated at 3 of 63 sitesv37
  22. Site details revised at 1 of 63 sitesv36
  23. Site details revised at 3 of 63 sitesv35
  24. Re-verified, no change to tracked fieldsv34
  25. Site details revised at 1 of 63 sitesv33
  26. Site details revised at 1 of 63 sitesv32
  27. Site details revised at 1 of 63 sitesv31
  28. Site details revised at 1 of 63 sitesv30
  29. Site details revised at 1 of 63 sitesv29
  30. Site details revised at 1 of 63 sitesv28
  31. Re-verified, no change to tracked fieldsv27
  32. Site details revised at 1 of 63 sitesv26
  33. Site details revised at 2 of 63 sitesv25
  34. Study sites: 62 to 63v24
  35. Primary completion date: Mar 28, 2025 to Oct 19, 2025
    • Study sites: 60 to 62
    • Study completion date: Jul 31, 2026 to Nov 1, 2026
    v23
  36. Study sites: 58 to 60v22
  37. Study sites: 55 to 58v21
  38. Study sites: 52 to 55v20
  39. Study sites: 47 to 52v19
  40. Study sites: 45 to 47v18
  41. Study sites: 44 to 45v17
  42. Study sites: 43 to 44v16
  43. Study sites: 41 to 43v15
  44. Study sites: 40 to 41v14
  45. Study sites: 39 to 40v13
  • 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.
Merck (MSD)
410 trials monitored
See 28 trials at risk
This is a randomized, active-controlled, double-blind clinical study designed to evaluate the antiretroviral activity, safety, and tolerability of doravirine/islatravir (DOR/ISL \[MK-8591A\]) in treatment-naïve participants with human immunodeficiency virus type 1 (HIV-1) infection. It is hypothesized that DOR/ISL is non-inferior to bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) as assessed by the percentage of participants with HIV-1 ribonucleic acid (RNA) \<50 copies/mL at Week 48.
Trial Details
NCT Number NCT05705349
Lead Sponsor Merck Sharp & Dohme LLC
Conditions
(from sponsor)		 HIV-1 Infection
Enrollment 537 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov