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A Phase 2b Study Evaluating Oral VH4524184 Regimens in Treatment Naïve Persons With HIV-1 (INNOVATE Study)

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Enrollment increased: 150 → 186 participants Trial sites expanded: 113 → 123 locations · Primary completion moved earlier from Jul 26, 2027 to Jun 11, 2027 · Completion moved earlier from Jul 24, 2028 to May 22, 2028 · 2 morev5 Show 5 more changesShow less
    • Trial sites expanded: 113 → 123 locations
    • Primary completion moved earlier from Jul 26, 2027 to Jun 11, 2027
    • Completion moved earlier from Jul 24, 2028 to May 22, 2028
    • Eligibility criteria expanded, about 23 words
    • Secondary endpoints: details revised at 3 of 7 entries

    See this version in full on ClinicalTrials.gov ↗

  2. Trial sites expanded: 62 → 113 locations Primary completion moved earlier from Sep 24, 2027 to Jul 26, 2027 · Completion moved earlier from Sep 22, 2028 to Jul 24, 2028v4 Show 2 more changesShow less
    • Primary completion moved earlier from Sep 24, 2027 to Jul 26, 2027
    • Completion moved earlier from Sep 22, 2028 to Jul 24, 2028
  3. Trial status: Not Yet Recruiting to Recruiting Enrollment target: 550 to 150 · Study sites: 0 to 62 · Primary completion date: May 20, 2027 to Sep 24, 2027 · 2 morev3 Show 5 more changesShow less
    • Enrollment target: 550 to 150
    • Study sites: 0 to 62
    • Primary completion date: May 20, 2027 to Sep 24, 2027
    • Completion date: Nov 1, 2028 to Sep 22, 2028
    • Start date changed from estimate of Feb 6, 2026 to Feb 11, 2026
  4. Start date: Nov 28, 2025 to Feb 6, 2026 Primary completion date: Jun 11, 2027 to May 20, 2027 · Completion date: Mar 19, 2029 to Nov 1, 2028v2 Show 2 more changesShow less
    • Primary completion date: Jun 11, 2027 to May 20, 2027
    • Completion date: Mar 19, 2029 to Nov 1, 2028
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This clinical study is testing a new medication, VH4524184, to see if it can effectively treat HIV-1 in adults who have never received treatment for their infection. The study is comparing two different doses of VH4524184, each taken with the medications emtricitabine and tenofovir alafenamide (FTC/TAF), to a standard HIV treatment called dolutegravir and lamivudine (DTG/3TC). The purpose of the study is to provide data on the long-term antiviral activity of the VH4524184 and provide information regarding dosing formulation for further evaluations.
Trial Details
NCT Number NCT07202546
Lead Sponsor ViiV Healthcare
Conditions HIV Infections
Enrollment 186 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov