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A Clinical Study of Islatravir and Ulonivirine for People With HIV-1 Who Have Not Been Treated Before (MK-8591B-062)

StatusRecruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Lead sponsor: Merck Sharp & Dohme LLC to Merck Sharp & Dohme LLC Primary endpoints: details revised at 2 of 6 entries · Primary completion moved earlier from Mar 21, 2029 to Feb 1, 2029 · Completion pushed from Apr 3, 2030 to Dec 18, 2031 · 4 more Show 7 more changesShow less
    • Primary endpoints: details revised at 2 of 6 entries
    • Primary completion moved earlier from Mar 21, 2029 to Feb 1, 2029
    • Completion pushed from Apr 3, 2030 to Dec 18, 2031
    • Interventions: BIC/FTC/TAF (Drug), ISL (Drug), ISL/ULO (Drug), Placebo for BIC/FTC/TAF (Drug), Placebo to ISL/ULO (Drug), ULO (Drug) to BIC/FTC/TAF (Drug), ISL (Drug), ISL/ULO (Drug), Placebo for BIC/FTC/TAF (Drug), Placebo to ISL/ULO (Drug), ULO (Drug)
    • Eligibility criteria expanded, about 9 words
    • Secondary endpoints: details revised at 18 of 24 entries
    • Site details revised at 4 of 55 sites
  2. Minor Re-verified, no change to tracked fieldsv23
  3. Minor Site details revised at 1 of 55 sitesv22
  4. Minor Site details revised at 2 of 55 sitesv21
  5. Minor Study sites: 56 to 55v20
Show 2 earlier versionsHide 2 earlier versions
  1. Minor Study sites: 55 to 56v19
  2. Minor Study sites: 53 to 55v18
  1. Minor Trial sites expanded: 49 → 53 locationsv17
  2. Minor Study sites: 47 to 49v16
  3. Minor Trial sites expanded: 42 → 47 locationsv15
  4. Minor Trial sites expanded: 34 → 42 locationsv14
  5. Minor Trial sites expanded: 31 → 34 locationsv13
  6. Minor Study sites: 29 to 31v12
  7. Minor Study sites: 24 to 29 Primary completion date: Apr 12, 2029 to Mar 21, 2029 · Completion date: Apr 25, 2030 to Apr 3, 2030v11 Show 2 more changesShow less
    • Primary completion date: Apr 12, 2029 to Mar 21, 2029
    • Completion date: Apr 25, 2030 to Apr 3, 2030
  8. Minor Study sites: 23 to 24v10
  9. Minor Study sites: 21 to 23 Primary completion date: Oct 5, 2029 to Apr 12, 2029v9 Show 1 more changeShow less
    • Primary completion date: Oct 5, 2029 to Apr 12, 2029
  10. Minor Study sites: 19 to 21v8
  11. Minor Study sites: 14 to 19v7
  12. Minor Study sites: 12 to 14v6
  13. Minor Study sites: 5 to 12v5
  14. Minor Study sites: 4 to 5v4
  15. Minor Study sites: 1 to 4 Start date changed from estimate of Jan 14, 2026 to Dec 18, 2025v3 Show 1 more changeShow less
    • Start date changed from estimate of Jan 14, 2026 to Dec 18, 2025
  16. Notable Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1v2 Show 1 more changeShow less
    • Study sites: 0 to 1
  17. Minor 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.
407 trials monitored
See 29 trials at risk
Researchers are looking for new ways to treat HIV-1 (Human Immunodeficiency Virus Type 1). The usual (standard) treatment for HIV-1 is antiretroviral therapy (ART), which includes taking medicines to lower the amount of HIV-1 in the body. Standard ART helps people live longer, but people must take up to 3 medicines up to twice a day. Standard ART may also cause other health problems. Researchers want to know if a study ART works as well as a standard ART to treat HIV-1. The study ART combines 2 medicines, islatravir and ulonivirine, and is taken once a week. The goals of this study are to learn: 1) If the study ART works as well as a standard ART to treat HIV-1, and 2) About the safety of the study ART and if people tolerate it compared to a standard ART.
Trial Details
NCT Number NCT07266831
Lead Sponsor Merck Sharp & Dohme LLC
Conditions Human Immunodeficiency Virus Type 1 (HIV-1) Infection
Enrollment 570 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov