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Study to Evaluate the Safety and Efficacy of Lenacapavir (GS-6207) in Combination With an Optimized Background Regimen (OBR) in Heavily Treatment Experienced Participants Living With HIV-1 Infection With Multidrug Resistance

Study acronym: CAPELLA
StatusActive, Not Recruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary endpoints: details revised at 1 of 1 entry Completion pushed from Jan 2027 to Jan 2028 · Eligibility criteria expanded, about 7 words · Secondary endpoints: details revised at 8 of 8 entries · 2 more Show 5 more changesShow less
    • Completion pushed from Jan 2027 to Jan 2028
    • Eligibility criteria expanded, about 7 words
    • Secondary endpoints: details revised at 8 of 8 entries
    • Site details revised at 5 of 75 sites
    • Publications: details revised at 13 of 21 entries
  2. Secondary endpoints revised (8) Publications: 4 to 21v32 Show 1 more changeShow less
    • Publications: 4 to 21

    See this version in full on ClinicalTrials.gov ↗

  3. Re-verified, no change to tracked fieldsv31
  4. Completion date: Dec 2025 to Jan 2027 Secondary endpoints: 4 to 8v30 Show 1 more changeShow less
    • Secondary endpoints: 4 to 8

    See this version in full on ClinicalTrials.gov ↗

  5. 2 versions Re-verified since Aug 28, 2023, no change to tracked fieldsv28-v29
Show 26 earlier versionsHide 26 earlier versions
  1. Completion date: Oct 2023 to Dec 2025v27
  2. Re-verified, no change to tracked fieldsv26
  3. Primary endpoint revised Secondary endpoints revised (4) · Publications: details revised at 1 of 4 entries · Study title expanded, about 1 wordv25 Show 3 more changesShow less
    • Secondary endpoints revised (4)
    • Publications: details revised at 1 of 4 entries
    • Study title expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  4. Results first posted: Oct 20, 2021 Primary endpoint revised · Interventions: Failing ARV Regimen (Drug), Optimized Background Regimen (OBR) (Drug), Oral Lenacapavir (Drug), Placebo oral tablet (Drug), Subcutaneous… to Failing ARV Regimen (Drug), Optimized Background Regimen (OBR) (Drug), Oral Lenacapavir (Drug), Oral Lenacapavir Placebo (Drug)… · Eligibility criteria expanded, about 10 words · 3 morev24 Show 6 more changesShow less
    • Primary endpoint revised
    • Interventions: Failing ARV Regimen (Drug), Optimized Background Regimen (OBR) (Drug), Oral Lenacapavir (Drug), Placebo oral tablet (Drug), Subcutaneous… to Failing ARV Regimen (Drug), Optimized Background Regimen (OBR) (Drug), Oral Lenacapavir (Drug), Oral Lenacapavir Placebo (Drug)…
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints revised (4)
    • Publications: 3 to 4
    • Study title expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  5. Re-verified, no change to tracked fieldsv23
  6. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 100 to confirmed 72 · Site details revised at 75 of 75 sitesv22 Show 2 more changesShow less
    • Enrollment target: estimated 100 to confirmed 72
    • Site details revised at 75 of 75 sites
  7. Re-verified, no change to tracked fieldsv21
  8. Primary completion date changed from estimate of Oct 2020 to Oct 5, 2020v20
  9. Re-verified, no change to tracked fieldsv19
  10. Study sites: 72 to 75v18
  11. Study sites: 70 to 72v17
  12. Study sites: 69 to 70v16
  13. Study sites: 54 to 69v15
  14. Study sites: 45 to 54v14
  15. Study sites: 39 to 45 Primary completion date: Aug 2020 to Oct 2020v13 Show 1 more changeShow less
    • Primary completion date: Aug 2020 to Oct 2020
  16. Study sites: 35 to 39v12
  17. Study sites: 33 to 35v11
  18. Study sites: 32 to 33v10
  19. Interventions: Failing ARV Regimen (Drug), Optimized Background Regimen (OBR) (Drug), Oral GS-6207 (Drug), Placebo oral tablet (Drug), Subcutaneous… to Failing ARV Regimen (Drug), Optimized Background Regimen (OBR) (Drug), Oral Lenacapavir (Drug), Placebo oral tablet (Drug), Subcutaneous… Eligibility criteria revised · Study title revisedv9 Show 2 more changesShow less
    • Eligibility criteria revised
    • Study title revised

    See this version in full on ClinicalTrials.gov ↗

  20. Study sites: 28 to 32v8
  21. Study sites: 22 to 28v7
  22. Study sites: 18 to 22v6
  23. Study sites: 15 to 18 Primary completion date: May 2021 to Aug 2020v5 Show 1 more changeShow less
    • Primary completion date: May 2021 to Aug 2020
  24. Study sites: 7 to 15v4
  25. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 7 · Start date changed from estimate of Dec 2019 to Nov 21, 2019v3 Show 2 more changesShow less
    • Study sites: 0 to 7
    • Start date changed from estimate of Dec 2019 to Nov 21, 2019
  26. Re-verified, no change to tracked fieldsv2
  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.
Gilead Sciences
113 trials monitored
See 11 trials at risk
The primary objective of this study is to evaluate the antiviral activity of lenacapavir (formerly GS-6207) administered as an add-on to a failing regimen for 14 days (functional monotherapy) in people with human immunodeficiency virus type 1 (HIV-1) (PWH) with multi-drug resistance (MDR).
Trial Details
NCT Number NCT04150068
Lead Sponsor Gilead Sciences
Conditions HIV-1-infection
Enrollment 72 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov