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First Time in Human Study of Long Acting VH4524184 Formulations

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Eligibility criteria revised Secondary endpoints: details revised at 1 of 1 entryv9 Show 1 more changeShow less
    • Secondary endpoints: details revised at 1 of 1 entry

    See this version in full on ClinicalTrials.gov ↗

  2. Enrollment increased: 268 → 372 participants Eligibility criteria revised · Site details revised at 1 of 3 sitesv8 Show 2 more changesShow less
    • Eligibility criteria revised
    • Site details revised at 1 of 3 sites

    See this version in full on ClinicalTrials.gov ↗

  3. Study sites: 2 to 3 Collaborators shortened, about 1 wordv7 Show 1 more changeShow less
    • Collaborators shortened, about 1 word

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  4. Enrollment target: 72 to 268 Interventions: Oral VH4524184 (Drug), Placebo Formulation A IM (Drug), Placebo Formulation A SC (Drug), Placebo Formulation B IM (Drug), Placebo… to Oral VH4524184 (Drug), Placebo Formulation A IM (Drug), Placebo Formulation A SC (Drug), Placebo Formulation B IM (Drug), Placebo… · Eligibility criteria expanded, about 124 words · Site contacts updated at 1 of 2 sites · 1 morev6 Show 4 more changesShow less
    • Interventions: Oral VH4524184 (Drug), Placebo Formulation A IM (Drug), Placebo Formulation A SC (Drug), Placebo Formulation B IM (Drug), Placebo… to Oral VH4524184 (Drug), Placebo Formulation A IM (Drug), Placebo Formulation A SC (Drug), Placebo Formulation B IM (Drug), Placebo…
    • Eligibility criteria expanded, about 124 words
    • Site contacts updated at 1 of 2 sites
    • Study arms: 6 to 5

    See this version in full on ClinicalTrials.gov ↗

  5. Primary completion date: Mar 29, 2027 to Jan 21, 2028 Site details revised at 2 of 2 sitesv5 Show 1 more changeShow less
    • Site details revised at 2 of 2 sites
Show 3 earlier versionsHide 3 earlier versions
  1. Interventions: Oral VH4524184 (Drug), Placebo Formulation A IM (Drug), Placebo Formulation A SC (Drug), Placebo Formulation B SC (Drug), Placebo… to Oral VH4524184 (Drug), Placebo Formulation A IM (Drug), Placebo Formulation A SC (Drug), Placebo Formulation B IM (Drug), Placebo… Site contacts updated at 1 of 2 sites · Study arms: 5 to 6 · Eligibility criteria expanded, about 4 wordsv4 Show 3 more changesShow less
    • Site contacts updated at 1 of 2 sites
    • Study arms: 5 to 6
    • Eligibility criteria expanded, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  2. Primary completion date: Mar 25, 2027 to Mar 29, 2027 Completion date: Jan 19, 2028 to Jan 21, 2028v3 Show 1 more changeShow less
    • Completion date: Jan 19, 2028 to Jan 21, 2028
  3. Trial status: Not Yet Recruiting to Recruiting Primary completion date: Feb 13, 2025 to Mar 25, 2027 · Primary endpoints revised (19) · Completion date: Nov 27, 2026 to Jan 19, 2028 · 2 morev2 Show 5 more changesShow less
    • Primary completion date: Feb 13, 2025 to Mar 25, 2027
    • Primary endpoints revised (19)
    • Completion date: Nov 27, 2026 to Jan 19, 2028
    • Start date changed from estimate of Mar 14, 2024 to Mar 21, 2024
    • Site details revised at 2 of 2 sites

    See this version in full on ClinicalTrials.gov ↗

  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 purpose of this study is to identify 1 or more doses of parenterally administered VH4524184 that are safe, well tolerated and yield a PK drug exposure profile necessary to deliver a long-acting antiretroviral therapy for the treatment of HIV-1 infection.
Trial Details
NCT Number NCT06310551
Lead Sponsor ViiV Healthcare
Conditions HIV Infections
Enrollment 372 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov