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A Clinical Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-011)

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

Record History

  1. Lead sponsor: Merck Sharp & Dohme LLC to Merck Sharp & Dohme LLC Enrollment closed, study ongoing · Interventions: FTC/TDF (Drug), MK-8527 (Drug), Placebo to FTC/TDF (Drug), Placebo to MK-8527 (Drug) to FTC/TDF (Drug), MK-8527 (Drug), Placebo to FTC/TDF (Drug), Placebo to MK-8527 (Drug) · Eligibility criteria expanded, about 11 words · 1 more Show 4 more changesShow less
    • Enrollment closed, study ongoing
    • Interventions: FTC/TDF (Drug), MK-8527 (Drug), Placebo to FTC/TDF (Drug), Placebo to MK-8527 (Drug) to FTC/TDF (Drug), MK-8527 (Drug), Placebo to FTC/TDF (Drug), Placebo to MK-8527 (Drug)
    • Eligibility criteria expanded, about 11 words
    • Site details revised at 81 of 81 sites
  2. Site details revised at 28 of 81 sitesv37
  3. Site details revised at 8 of 81 sitesv36
  4. Site details revised at 1 of 81 sitesv35
  5. Site details revised at 4 of 81 sitesv34
Show 6 earlier versionsHide 6 earlier versions
  1. Study sites revised (81)v33 See this version in full on ClinicalTrials.gov ↗
  2. Site details revised at 4 of 81 sitesv32
  3. Site details revised at 6 of 81 sitesv31
  4. Site details revised at 7 of 81 sitesv30
  5. Site details revised at 1 of 81 sitesv29
  6. Site details revised at 12 of 81 sitesv28
  1. Trial sites expanded: 78 → 81 locationsv27
  2. Site details revised at 1 of 78 sitesv26
  3. Study sites: 76 to 78v25
  4. Study sites: 74 to 76v24
  5. Study sites: 70 to 74v23
  6. Study sites: 69 to 70v22
  7. Study sites: 68 to 69v21
  8. Study sites: 66 to 68v20
  9. Study sites: 63 to 66v19
  10. Study sites: 59 to 63v18
  11. Study sites: 53 to 59v17
  12. Study sites: 51 to 53v16
  13. Study sites: 46 to 51v15
  14. Site details revised at 1 of 46 sitesv14
  15. Study sites: 42 to 46v13
  16. Study sites: 35 to 42v12
  17. Study sites: 33 to 35v11
  18. Study sites: 27 to 33 Primary and study completion dates: Oct 20, 2027 to Jul 22, 2027v10 Show 1 more changeShow less
    • Primary and study completion dates: Oct 20, 2027 to Jul 22, 2027
  19. Study sites: 21 to 27v9
  20. Study sites: 19 to 21v8
  21. Study sites: 18 to 19v7
  22. Study sites: 15 to 18v6
  23. Study sites: 10 to 15v5
  24. Study sites: 3 to 10v4
  25. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 3v3 Show 1 more changeShow less
    • Study sites: 0 to 3
  26. Re-verified, no change to tracked fieldsv2
  27. 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.
Merck (MSD)
407 trials monitored
See 29 trials at risk
Researchers are looking for new medicines to prevent HIV-1 (Human Immunodeficiency Virus Type 1) infection. The goals of this study are to learn: * If taking MK-8527 once a month works to prevent HIV-1 infection as well as or better than a standard (usual) pre-exposure prophylaxis (PrEP) taken once a day * About the safety of MK-8527 and if people tolerate it
Trial Details
NCT Number NCT07044297
Lead Sponsor Merck Sharp & Dohme LLC
Conditions Human Immunodeficiency Virus (HIV), HIV Pre-Exposure Prophylaxis
Enrollment 4,390 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov