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Evaluating the Safety and Efficacy of Long-Acting Injectable Cabotegravir Compared to Daily Oral TDF/FTC for Pre-Exposure Prophylaxis in HIV-Uninfected Women

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Completion date: Nov 30, 2024 to Oct 17, 2026 Site details revised at 1 of 20 sitesv26 Show 1 more changeShow less
    • Site details revised at 1 of 20 sites
  2. Re-verified, no change to tracked fieldsv25
  3. Results first posted: Mar 28, 2023 Primary endpoints revised (2) · Secondary endpoints shortened, about 73 wordsv24 Show 2 more changesShow less
    • Primary endpoints revised (2)
    • Secondary endpoints shortened, about 73 words

    See this version in full on ClinicalTrials.gov ↗

  4. Primary completion date changed from estimate of May 31, 2022 to Nov 5, 2020 Completion date: May 31, 2022 to Nov 30, 2024v23 Show 1 more changeShow less
    • Completion date: May 31, 2022 to Nov 30, 2024
  5. Primary endpoints revised (2) Enrollment target: estimated 3200 to confirmed 3224 · Secondary endpoints: 8 to 4v22 Show 2 more changesShow less
    • Enrollment target: estimated 3200 to confirmed 3224
    • Secondary endpoints: 8 to 4

    See this version in full on ClinicalTrials.gov ↗

Show 20 earlier versionsHide 20 earlier versions
  1. Trial status: Recruiting to Active, Not Recruiting Site details revised at 20 of 20 sitesv21 Show 1 more changeShow less
    • Site details revised at 20 of 20 sites
  2. Site contacts updated at 3 of 20 sitesv20
  3. Primary endpoints revised (2) Eligibility criteria expanded, about 104 words · Secondary endpoints: 7 to 8 · Study description expanded, about 85 wordsv19 Show 3 more changesShow less
    • Eligibility criteria expanded, about 104 words
    • Secondary endpoints: 7 to 8
    • Study description expanded, about 85 words

    See this version in full on ClinicalTrials.gov ↗

  4. Primary and study completion dates: May 2022 to May 31, 2022 Study sites revised (20)v18 Show 1 more changeShow less
    • Study sites revised (20)

    See this version in full on ClinicalTrials.gov ↗

  5. Study sites: 19 to 20v17
  6. Study sites: 18 to 19v16
  7. Study sites: 17 to 18v15
  8. Study sites: 16 to 17v14
  9. Study sites: 15 to 16v13
  10. Eligibility criteria expanded, about 55 words Study description expanded, about 1 wordv12 Show 1 more changeShow less
    • Study description expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  11. Site contacts updated at 2 of 15 sitesv11
  12. Study sites: 13 to 15v10
  13. Study sites: 11 to 13v9
  14. Study sites: 10 to 11v8
  15. Study sites: 8 to 10v7
  16. Study sites: 4 to 8v6
  17. Study sites: 3 to 4v5
  18. Start date: Nov 1, 2017 to Nov 7, 2017v4
  19. Trial status: Not Yet Recruiting to Recruiting Study sites: 2 to 3 · Start date changed from estimate of Oct 2017 to Nov 1, 2017v3 Show 2 more changesShow less
    • Study sites: 2 to 3
    • Start date changed from estimate of Oct 2017 to Nov 1, 2017
  20. Study sites: 0 to 2v2
  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 study will evaluate the safety and efficacy of the long-acting injectable agent cabotegravir (CAB LA) compared to daily oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) for pre-exposure prophylaxis (PrEP) in HIV-uninfected women.
Trial Details
NCT Number NCT03164564
Lead Sponsor National Institute of Allergy and Infectious Diseases (NIAID)
Conditions HIV Infections
Enrollment 3,224 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov