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A Study to Investigate the Use of VH3810109 With or Without Fostemsavir (FTR) to Reduce the Size and Activity of the Viral Reservoir in People Living With HIV

Study acronym: ENTRANCE
StatusActive, Not Recruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Final enrollment: 107 participants (planned 130) Eligibility criteria expanded, about 22 words · Secondary endpoints: details revised at 1 of 10 entries · Site details revised at 24 of 41 sites Show 3 more changesShow less
    • Eligibility criteria expanded, about 22 words
    • Secondary endpoints: details revised at 1 of 10 entries
    • Site details revised at 24 of 41 sites
  2. Primary endpoint(s) modified Enrollment increased: 107 → 130 participants · Trial arms changed: 3 → 4 · Eligibility criteria expanded, about 37 words · 1 morev7 Show 4 more changesShow less
    • Enrollment increased: 107 → 130 participants
    • Trial arms changed: 3 → 4
    • Eligibility criteria expanded, about 37 words
    • Secondary endpoints: 8 to 10

    See this version in full on ClinicalTrials.gov ↗

  3. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 100 to confirmed 107 · Primary completion date: Jan 18, 2027 to Jan 22, 2027 · Completion date: Mar 24, 2028 to Sep 6, 2028 · 1 morev6 Show 4 more changesShow less
    • Enrollment target: estimated 100 to confirmed 107
    • Primary completion date: Jan 18, 2027 to Jan 22, 2027
    • Completion date: Mar 24, 2028 to Sep 6, 2028
    • Site details revised at 41 of 41 sites
  4. Study sites: 9 to 41 Primary completion date: Feb 24, 2027 to Jan 18, 2027v5 Show 1 more changeShow less
    • Primary completion date: Feb 24, 2027 to Jan 18, 2027
  5. Study sites: 6 to 9v4
Show 2 earlier versionsHide 2 earlier versions
  1. Study sites: 2 to 6v3
  2. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 2v2 Show 1 more changeShow less
    • Study sites: 0 to 2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 study investigates the use of VH3810109 with or without FTR to reduce the size and activity of the HIV viral reservoir in two sub-populations of people living with HIV: treatment-naïve adults (Population 1) and treatment-experienced adults currently taking a standard of care (SOC) integrase strand transfer inhibitor (INSTI)-based antiretroviral therapy (ART) regimen (Population 2). The study is designed to include the following phases: Randomized Intervention Phase (Step 1), Analytical Treatment Interruption (ATI) Phase (Step 2), and Follow-up Phase (Step 3).
Trial Details
NCT Number NCT07053384
Lead Sponsor ViiV Healthcare
Conditions HIV Infections
Enrollment 107 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov