Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06741397 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a New Formulation of Cabotegravir Long-Acting Administered Intramuscularly in a 4-month Dosing Interval (Q4M)

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary endpoints: details revised at 1 of 1 entry Completion pushed from Jan 10, 2029 to Aug 30, 2029 · Eligibility criteria expanded, about 55 words · Secondary endpoints: details revised at 4 of 11 entries · 1 more Show 4 more changesShow less
    • Completion pushed from Jan 10, 2029 to Aug 30, 2029
    • Eligibility criteria expanded, about 55 words
    • Secondary endpoints: details revised at 4 of 11 entries
    • Site details revised at 6 of 27 sites
  2. Enrollment target: 228 to 229 Secondary endpoints: details revised at 1 of 11 entries · Site details revised at 2 of 27 sites · Eligibility criteria expanded, about 2 wordsv6 Show 3 more changesShow less
    • Secondary endpoints: details revised at 1 of 11 entries
    • Site details revised at 2 of 27 sites
    • Eligibility criteria expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  3. Enrollment target: 191 to 228 Primary completion date: Sep 3, 2026 to Sep 9, 2026 · Completion date: Dec 28, 2028 to Jan 10, 2029v5 Show 2 more changesShow less
    • Primary completion date: Sep 3, 2026 to Sep 9, 2026
    • Completion date: Dec 28, 2028 to Jan 10, 2029
  4. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 200 to confirmed 191 · Study sites: 19 to 27 · Primary completion date: Sep 22, 2026 to Sep 3, 2026v4 Show 3 more changesShow less
    • Enrollment target: estimated 200 to confirmed 191
    • Study sites: 19 to 27
    • Primary completion date: Sep 22, 2026 to Sep 3, 2026
  5. Study sites: 14 to 19v3
  6. Trial status: Not Yet Recruiting to Recruiting Study sites: 28 to 14 · Primary completion date: Aug 28, 2026 to Sep 22, 2026v2 Show 2 more changesShow less
    • Study sites: 28 to 14
    • Primary completion date: Aug 28, 2026 to Sep 22, 2026
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 will evaluate the pharmacokinetics (PK), safety, and tolerability of a new formulation of Cabotegravir (CAB) dosed every 4-months (Q4M) for pre-exposure prophylaxis (PrEP) in participants at risk of HIV-1 acquisition.
Trial Details
NCT Number NCT06741397
Lead Sponsor ViiV Healthcare
Conditions HIV Infections
Enrollment 229 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov