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Long-term Follow-up of Long-acting Cabotegravir (CAB LA) for PrEP (Pre-exposure Prophylaxis) in Participants at Risk of Acquiring HIV (Human Immunodeficiency Virus)

Study acronym: PALISADE
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 months later Jan 1, 2029 → Mar 14, 2029
Enrollment reduced 15% 3508 → 2996 participants
See other at-risk trials from ViiV Healthcare

Record History

  1. Enrollment closed, study ongoing Primary and study completion pushed from Jan 1, 2029 to Mar 14, 2029 · Enrollment reduced: 3508 → 2996 participants · Study sites: 34 to 33v12 Show 3 more changesShow less
    • Primary and study completion pushed from Jan 1, 2029 to Mar 14, 2029
    • Enrollment reduced: 3508 → 2996 participants
    • Study sites: 34 to 33
  2. Enrollment target: 3500 to 3508 Primary and study completion dates: Sep 29, 2028 to Jan 1, 2029 · Start date: May 24, 2024 to May 14, 2024 · Site details revised at 8 of 34 sitesv11 Show 3 more changesShow less
    • Primary and study completion dates: Sep 29, 2028 to Jan 1, 2029
    • Start date: May 24, 2024 to May 14, 2024
    • Site details revised at 8 of 34 sites
  3. Primary and study completion dates: Aug 16, 2028 to Sep 29, 2028 Site contacts updated at 2 of 34 sitesv10 Show 1 more changeShow less
    • Site contacts updated at 2 of 34 sites
  4. Primary and study completion dates: Jun 26, 2028 to Aug 16, 2028 Site contacts updated at 1 of 34 sitesv9 Show 1 more changeShow less
    • Site contacts updated at 1 of 34 sites
  5. Study sites: 25 to 34 Start date: May 14, 2024 to May 24, 2024v8 Show 1 more changeShow less
    • Start date: May 14, 2024 to May 24, 2024
Show 6 earlier versionsHide 6 earlier versions
  1. Study sites: 22 to 25v7
  2. Study sites: 18 to 22 Eligibility criteria expanded, about 38 wordsv6 Show 1 more changeShow less
    • Eligibility criteria expanded, about 38 words

    See this version in full on ClinicalTrials.gov ↗

  3. Study sites: 35 to 18v5
  4. Trial status: Not Yet Recruiting to Recruiting Primary and study completion dates: Jun 24, 2027 to Jun 26, 2028 · Start date changed from estimate of Apr 1, 2024 to May 14, 2024 · Eligibility criteria expanded, about 169 words · 1 morev4 Show 4 more changesShow less
    • Primary and study completion dates: Jun 24, 2027 to Jun 26, 2028
    • Start date changed from estimate of Apr 1, 2024 to May 14, 2024
    • Eligibility criteria expanded, about 169 words
    • Site details revised at 35 of 35 sites

    See this version in full on ClinicalTrials.gov ↗

  5. Start date: Jan 5, 2024 to Apr 1, 2024 Study sites: 0 to 35 · Primary and study completion dates: Mar 31, 2027 to Jun 24, 2027v3 Show 2 more changesShow less
    • Study sites: 0 to 35
    • Primary and study completion dates: Mar 31, 2027 to Jun 24, 2027
  6. Collaborators expanded, about 4 wordsv2 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 long-term evaluation of long-acting injectable cabotegravir (CAB LA) for HIV pre-exposure prophylaxis (PrEP) in eligible participants who have completed DAIDS (Division of AIDS) sponsored studies HPTN 083 and HPTN 084 and associated sub-studies. Participants will continue receiving CAB LA and be followed for new HIV diagnosis, SAEs (serious adverse events), Grade 3 and Grade 4 ISRs (injection site reactions), and AEs (adverse events) leading to withdrawal.
Trial Details
NCT Number NCT06134362
Lead Sponsor ViiV Healthcare
Collaborators: GlaxoSmithKline, PPD Development, LP
Conditions HIV Infections
Enrollment 2,996 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov