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A Study to Investigate Pharmacokinetics, Safety and Tolerability of Long-Acting Cabotegravir Plus Recombinant Human Hyaluronidase PH20 in Healthy Adult Participants

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Jul 6, 2026 to Jun 8, 2027 Enrollment target: 180 to 214 · Completion date: Nov 2, 2027 to Jun 8, 2027 · Site contacts updated at 1 of 3 sitesv15 Show 3 more changesShow less
    • Enrollment target: 180 to 214
    • Completion date: Nov 2, 2027 to Jun 8, 2027
    • Site contacts updated at 1 of 3 sites
  2. Primary endpoints: 43 to 45 Interventions: Cabotegravir >=400 mg/mL (Drug), Cabotegravir 200 mg/mL (Drug), Cabotegravir Formulation I (Drug), RPV (Drug), rHuPH20 (Drug) to CAB Formulation J (Drug), Cabotegravir >=400 mg/mL (Drug), Cabotegravir 200 mg/mL (Drug), Cabotegravir Formulation I (Drug), RPV (Drug)… · Secondary endpoints: details revised at 6 of 7 entries · Site details revised at 2 of 3 sites · 1 morev14 Show 4 more changesShow less
    • Interventions: Cabotegravir >=400 mg/mL (Drug), Cabotegravir 200 mg/mL (Drug), Cabotegravir Formulation I (Drug), RPV (Drug), rHuPH20 (Drug) to CAB Formulation J (Drug), Cabotegravir >=400 mg/mL (Drug), Cabotegravir 200 mg/mL (Drug), Cabotegravir Formulation I (Drug), RPV (Drug)…
    • Secondary endpoints: details revised at 6 of 7 entries
    • Site details revised at 2 of 3 sites
    • Study arms: 4 to 3

    See this version in full on ClinicalTrials.gov ↗

  3. Primary completion date: Aug 3, 2026 to Jul 6, 2026v13
  4. Enrollment target: 60 to 180 Primary endpoints: 35 to 43 · Primary completion date: Oct 5, 2026 to Aug 3, 2026 · Interventions: Cabotegravir 200 mg/mL (Drug), Cabotegravir Formulation I (Drug), Cabotegravir ≥400 mg/mL (Drug), Recombinant human hyaluronidase PH20… to Cabotegravir >=400 mg/mL (Drug), Cabotegravir 200 mg/mL (Drug), Cabotegravir Formulation I (Drug), RPV (Drug), rHuPH20 (Drug) · 4 morev12 Show 7 more changesShow less
    • Primary endpoints: 35 to 43
    • Primary completion date: Oct 5, 2026 to Aug 3, 2026
    • Interventions: Cabotegravir 200 mg/mL (Drug), Cabotegravir Formulation I (Drug), Cabotegravir ≥400 mg/mL (Drug), Recombinant human hyaluronidase PH20… to Cabotegravir >=400 mg/mL (Drug), Cabotegravir 200 mg/mL (Drug), Cabotegravir Formulation I (Drug), RPV (Drug), rHuPH20 (Drug)
    • Eligibility criteria revised
    • Secondary endpoints revised (7)
    • Collaborators expanded, about 6 words
    • Study arms: 3 to 4

    See this version in full on ClinicalTrials.gov ↗

  5. Primary completion date: Feb 26, 2026 to Oct 5, 2026 Interventions: Cabotegravir 200 mg/mL (Drug), Cabotegravir 400 mg/mL (Drug), Recombinant human hyaluronidase PH20 (rHuPH20) (Drug) to Cabotegravir 200 mg/mL (Drug), Cabotegravir Formulation I (Drug), Cabotegravir ≥400 mg/mL (Drug), Recombinant human hyaluronidase PH20… · Secondary endpoints: details revised at 6 of 7 entriesv11 Show 2 more changesShow less
    • Interventions: Cabotegravir 200 mg/mL (Drug), Cabotegravir 400 mg/mL (Drug), Recombinant human hyaluronidase PH20 (rHuPH20) (Drug) to Cabotegravir 200 mg/mL (Drug), Cabotegravir Formulation I (Drug), Cabotegravir ≥400 mg/mL (Drug), Recombinant human hyaluronidase PH20…
    • Secondary endpoints: details revised at 6 of 7 entries
Show 9 earlier versionsHide 9 earlier versions
  1. Study sites: 4 to 3 Primary completion date: Nov 11, 2025 to Feb 26, 2026 · Completion date: Nov 12, 2025 to Nov 2, 2027v10 Show 2 more changesShow less
    • Primary completion date: Nov 11, 2025 to Feb 26, 2026
    • Completion date: Nov 12, 2025 to Nov 2, 2027
  2. Primary completion date: Sep 1, 2025 to Nov 11, 2025 Completion date: Sep 1, 2025 to Nov 12, 2025 · Site details revised at 2 of 4 sitesv9 Show 2 more changesShow less
    • Completion date: Sep 1, 2025 to Nov 12, 2025
    • Site details revised at 2 of 4 sites
  3. Primary completion date: Oct 23, 2023 to Sep 1, 2025 Completion date: May 17, 2024 to Sep 1, 2025v8 Show 1 more changeShow less
    • Completion date: May 17, 2024 to Sep 1, 2025
  4. Eligibility criteria expanded, about 39 words Site details revised at 1 of 4 sitesv7 Show 1 more changeShow less
    • Site details revised at 1 of 4 sites

    See this version in full on ClinicalTrials.gov ↗

  5. Primary endpoints: 37 to 35 Study sites: 3 to 4 · Primary completion date: Oct 19, 2023 to Oct 23, 2023 · Eligibility criteria expanded, about 18 words · 2 morev6 Show 5 more changesShow less
    • Study sites: 3 to 4
    • Primary completion date: Oct 19, 2023 to Oct 23, 2023
    • Eligibility criteria expanded, about 18 words
    • Secondary endpoints: details revised at 1 of 7 entries
    • Study arms: 2 to 3

    See this version in full on ClinicalTrials.gov ↗

  6. Study sites: 2 to 3 Primary completion date: Jan 1, 2024 to Oct 19, 2023v5 Show 1 more changeShow less
    • Primary completion date: Jan 1, 2024 to Oct 19, 2023
  7. Study sites: 1 to 2 Primary completion date: Jan 2, 2024 to Jan 1, 2024v4 Show 1 more changeShow less
    • Primary completion date: Jan 2, 2024 to Jan 1, 2024
  8. Re-verified, no change to tracked fieldsv3
  9. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Primary completion date: Dec 21, 2023 to Jan 2, 2024 · Completion date: May 16, 2024 to May 17, 2024 · 1 morev2 Show 4 more changesShow less
    • Study sites: 0 to 1
    • Primary completion date: Dec 21, 2023 to Jan 2, 2024
    • Completion date: May 16, 2024 to May 17, 2024
    • Start date changed from estimate of Jun 13, 2022 to Jun 14, 2022
  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 is an open-label, dose-escalation study to investigate the safety, tolerability and pharmacokinetics (PK) of single subcutaneous (SC) administration of long acting (LA) Cabotegravir (CAB) 200 milligrams per milliliter (mg/mL) with Recombinant Human Hyaluronidase PH20 (rHuPH20) (Part A), a single-dose or repeat-dose SC or intramuscular (IM) administration of LA CAB (greater than or equal to) \>=400 mg/mL (Part C), single-dose IM administration of LA CAB Formulation I (Part C Cohort C8) and LA CAB Formulation J (Part C Cohort C11), and a single-dose or repeat-dose IM administration of rilpivirine (RPV) (Part E). Part A of the study (CAB 200 mg/mL with rHuPh20) has been closed to further enrolment based on preliminary results. Part D of the study (CAB \>=400 mg/mL with rHuPH20) will not be conducted due to changes in the study design.
Trial Details
NCT Number NCT05418868
Lead Sponsor ViiV Healthcare
Collaborators: GlaxoSmithKline, Janssen Sciences Ireland Unlimited Company
Conditions HIV Infections
Enrollment 214 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov