Study of Bictegravir/Emtricitabine/Tenofovir Alafenamide Fixed Dose Combination in Adolescents and Children With Human Immunodeficiency Virus-1

StatusActive, Not Recruiting
PhasePhase 2/3
Started

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Record History

The 50 most recent of 62 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Study completion pushed from Nov 2026 to Jun 2027 Show 4 more changesShow less
    • Interventions: B/F/TAF (Adult Strength) (Drug), B/F/TAF (Low Dose) (Drug), B/F/TAF (TOS) (Drug), B/F/TAF (TOS) (Drug), B/F/TAF (TOS) (Drug), B/F/TAF (TOS)… to B/F/TAF (Adult Strength) (Drug), B/F/TAF (Low Dose) (Drug), B/F/TAF (TOS) (Drug), B/F/TAF (TOS) (Drug), B/F/TAF (TOS) (Drug), B/F/TAF (TOS)…
    • Eligibility criteria shortened, about 31 words
    • Secondary endpoints: details revised at 30 of 36 entries
    • Site details revised at 7 of 25 sites
  2. 2 versions Re-verified since Feb 12, 2026, no change to tracked fieldsv60-v61
  3. Study completion date: Sep 2025 to Nov 2026v59
  4. Primary endpoints: 6 to 7
    • Primary completion date changed from estimate of Mar 2025 to Mar 24, 2025
    v58
  5. Primary completion date: Jun 2024 to Mar 2025v57 Show 4 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 170 to confirmed 177
    • Study sites: 26 to 25
    • Study completion date: Dec 2024 to Sep 2025
Show 44 earlier versionsHide 44 earlier versions
  1. Enrollment target: 172 to 170
    • Site details revised at 2 of 26 sites
    v56
  2. Site details revised at 2 of 26 sitesv55
  3. Re-verified, no change to tracked fieldsv54
  4. Eligibility criteria expanded, about 3 wordsv53
  5. Re-verified, no change to tracked fieldsv52
  6. Study sites: 25 to 26v51
  7. Re-verified, no change to tracked fieldsv50
  8. Study sites: 24 to 25v49
  9. Study sites: 23 to 24v48
  10. 2 versions Re-verified since May 3, 2023, no change to tracked fieldsv46-v47
  11. Study sites revised (23)
    • Study title expanded, about 7 words
    v45
  12. Trial status: Active, Not Recruiting to Recruiting
    • Enrollment target: 122 to 172
    • Study sites: 22 to 23
    v44
  13. Primary completion date: May 2023 to Jun 2024
    • Study completion date: Jul 2026 to Dec 2024
    • Secondary endpoints: details revised at 4 of 36 entries
    v43
  14. 3 versions Re-verified since Jun 3, 2022, no change to tracked fieldsv40-v42
  15. Primary completion date: Jul 31, 2022 to May 2023
    • Study completion date: Nov 2024 to Jul 2026
    v39
  16. Re-verified, no change to tracked fieldsv38
  17. Study completion date: Nov 2023 to Nov 2024v37
  18. 2 versions Re-verified since Dec 18, 2020, no change to tracked fieldsv35-v36
  19. Primary completion date: Jan 31, 2022 to Jul 31, 2022v34 Show 4 more changesShow less
    • Interventions: B/F/TAF (Adult Strength) (Drug), B/F/TAF (Low Dose) (Drug) to B/F/TAF (Adult Strength) (Drug), B/F/TAF (Low Dose) (Drug), B/F/TAF (TOS) (Drug), B/F/TAF (TOS) (Drug), B/F/TAF (TOS) (Drug), B/F/TAF (TOS)…
    • Eligibility criteria expanded, about 262 words
    • Secondary endpoints: 26 to 36
    • Study arms: 4 to 8
  20. Re-verified, no change to tracked fieldsv33
  21. Primary completion date: Jul 2020 to Jan 31, 2022v32
  22. 2 versions Re-verified since May 29, 2020, no change to tracked fieldsv30-v31
  23. Study sites revised (22)v29
  24. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 125 to confirmed 122
    • Study sites revised (22)
    v28
  25. Study sites revised (22)v27
  26. Primary completion date: Oct 2019 to Jul 2020v26
  27. Re-verified, no change to tracked fieldsv25
  28. Site details revised at 1 of 22 sitesv24
  29. 3 versions Re-verified since May 30, 2019, no change to tracked fieldsv21-v23
  30. Study sites: 21 to 22v20
  31. Re-verified, no change to tracked fieldsv19
  32. Trial status: Active, Not Recruiting to Recruitingv18 Show 4 more changesShow less
    • Primary completion date: Jul 16, 2018 to Oct 2019
    • Enrollment target: 101 to 125
    • Study completion date: Nov 2020 to Nov 2023
    • Study sites revised (21)
  33. Interventions: B/F/TAF (Drug) to B/F/TAF (Adult Strength) (Drug), B/F/TAF (Low Dose) (Drug)
    • Study arms: 2 to 4
    v17
  34. Primary completion date: Jul 9, 2018 to Jul 16, 2018v16
  35. Primary completion date changed from estimate of Dec 2018 to Jul 9, 2018
    • Study completion date: Jan 2019 to Nov 2020
    v15
  36. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 100 to confirmed 101
    • Study sites: 23 to 21
    v14
  37. Trial status: Active, Not Recruiting to Recruiting
    • Study sites revised (23)
    v13
  • 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 12 trials at risk
The goals of this clinical study are to learn how Bictegravir/Emtricitabine/Tenofovir Alafenamide fixed dose combination (FDC) interacts with the body, confirm the dose, and also to learn more about the safety and tolerability of Bictegravir/Emtricitabine/Tenofovir Alafenamide FDC in adolescents and children with HIV-1.
Trial Details
NCT Number NCT02881320
Lead Sponsor Gilead Sciences
Conditions
(from sponsor)		 HIV-1 Infection
Enrollment 177 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov