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A Study to Investigate the Virologic Efficacy and Safety of VH3810109 + Cabotegravir Compared to Standard of Care (SOC) in Male and Female Adults Living With Human Immunodeficiency Virus (HIV)

Study acronym: EMBRACE
StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date changed from estimate of May 22, 2026 to May 27, 2026 Site details revised at 2 of 45 sitesv13 Show 1 more changeShow less
    • Site details revised at 2 of 45 sites
  2. Primary completion date: May 15, 2026 to May 22, 2026 Site details revised at 1 of 45 sitesv12 Show 1 more changeShow less
    • Site details revised at 1 of 45 sites
  3. Primary completion date: Nov 14, 2024 to May 15, 2026 Enrollment target: 128 to 185 · Completion date: Jan 17, 2029 to Nov 9, 2028 · Site details revised at 1 of 45 sitesv11 Show 3 more changesShow less
    • Enrollment target: 128 to 185
    • Completion date: Jan 17, 2029 to Nov 9, 2028
    • Site details revised at 1 of 45 sites
  4. Primary endpoint revised Enrollment target: 135 to 128 · Eligibility criteria expanded, about 94 words · Secondary endpoints revised (18) · 2 morev10 Show 5 more changesShow less
    • Enrollment target: 135 to 128
    • Eligibility criteria expanded, about 94 words
    • Secondary endpoints revised (18)
    • Site details revised at 7 of 45 sites
    • Study arms: 3 to 8

    See this version in full on ClinicalTrials.gov ↗

  5. Secondary endpoints revised (18) Eligibility criteria shortened, about 3 wordsv9 Show 1 more changeShow less
    • Eligibility criteria shortened, about 3 words

    See this version in full on ClinicalTrials.gov ↗

Show 7 earlier versionsHide 7 earlier versions
  1. Enrollment target: 134 to 135 Completion date: Jun 1, 2026 to Jan 17, 2029v8 Show 1 more changeShow less
    • Completion date: Jun 1, 2026 to Jan 17, 2029
  2. Enrollment target: 128 to 134 Primary completion date changed from estimate of Nov 28, 2024 to Nov 14, 2024 · Completion date: May 25, 2026 to Jun 1, 2026 · Site details revised at 2 of 45 sitesv7 Show 3 more changesShow less
    • Primary completion date changed from estimate of Nov 28, 2024 to Nov 14, 2024
    • Completion date: May 25, 2026 to Jun 1, 2026
    • Site details revised at 2 of 45 sites
  3. Enrollment target: 99 to 128 Site details revised at 9 of 45 sitesv6 Show 1 more changeShow less
    • Site details revised at 9 of 45 sites
  4. Enrollment target: 45 to 99 Primary completion date: Nov 29, 2024 to Nov 28, 2024 · Completion date: May 15, 2026 to May 25, 2026v5 Show 2 more changesShow less
    • Primary completion date: Nov 29, 2024 to Nov 28, 2024
    • Completion date: May 15, 2026 to May 25, 2026
  5. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 150 to confirmed 45 · Primary completion date: Oct 30, 2024 to Nov 29, 2024 · Completion date: Apr 24, 2026 to May 15, 2026 · 2 morev4 Show 5 more changesShow less
    • Enrollment target: estimated 150 to confirmed 45
    • Primary completion date: Oct 30, 2024 to Nov 29, 2024
    • Completion date: Apr 24, 2026 to May 15, 2026
    • Eligibility criteria expanded, about 670 words
    • Site details revised at 45 of 45 sites

    See this version in full on ClinicalTrials.gov ↗

  6. Study sites: 44 to 45 Primary completion date: Oct 23, 2024 to Oct 30, 2024 · Completion date: Apr 17, 2026 to Apr 24, 2026v3 Show 2 more changesShow less
    • Primary completion date: Oct 23, 2024 to Oct 30, 2024
    • Completion date: Apr 17, 2026 to Apr 24, 2026
  7. Trial status: Not Yet Recruiting to Recruiting Study sites: 43 to 44 · Start date changed from estimate of Aug 10, 2023 to Aug 17, 2023v2 Show 2 more changesShow less
    • Study sites: 43 to 44
    • Start date changed from estimate of Aug 10, 2023 to Aug 17, 2023
  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.
The study aims at evaluating the efficacy of VH3810109, dosed in accordance with the dosing schedule as either intravenous (IV) infusion or subcutaneous (SC) infusion with recombinant hyaluronidase (rHuPH20), in combination with cabotegravir (CAB) intramuscular (IM) dosed in accordance with the dosing schedule in virologically suppressed, Antiretroviral therapy (ART)-experienced adult participants living with HIV. VH3810109 plus rHuPH20 plus Cabotegravir arm of the study has been discontinued based on preliminary results. The study will be conducted in 3 parts followed by a Long-Term Follow-up phase (LTFU).
Trial Details
NCT Number NCT05996471
Lead Sponsor ViiV Healthcare
Conditions HIV Infections
Enrollment 185 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov