Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06037564 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

B-free Multistage Trial

Study acronym: B-free
StatusEnrolling by Invitation
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion date: Nov 2025 to Oct 2026
    • Study sites: 7 to 8
    • Study completion date: Dec 2027 to Sep 2027
    • Eligibility criteria shortened, about 6 words
    v5
  2. Re-verified, no change to tracked fieldsv4
  3. Trial status: Recruiting to Enrolling by Invitationv3 Show 4 more changesShow less
    • Primary completion date: Aug 2025 to Nov 2025
    • Study completion date: Aug 2027 to Dec 2027
    • Start date changed from estimate of Oct 2023 to Nov 13, 2023
    • Site details revised at 7 of 7 sites
  4. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised at 7 of 7 sites
    v2
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 primary objective of the study is to evaluate the efficacy of a booster-free regimen including DOR/DTG/3TC among HIV-suppressed PLWH with previous virological failure. The key secondary objectives are i) to determine whether switching to DOR / DTG / 3TC leads to lower burden of DDI compared to continuing a booster-containing regimen, and ii) to assess changes in patient perception on treatment acceptability and satisfaction, as well as health-related quality of life after a switch to booster-free ART. Qualitative sub-study: Qualitative objectives will be met using semi-structured interviews. Thirty people (15 from the intervention arm, 15 from the control arm) will be interviewed twice, at week 0 and week 48. Additional 15 individuals from the observational cohort will be interviewed once. Interviews will take place following study visits and performed using semi-structured guides. The guide for the interviews at week 48 will be based on results from analyses of the interviews conducted at week 0.
Trial Details
NCT Number NCT06037564
Lead Sponsor Insel Gruppe AG, University Hospital Bern
Collaborators: Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland, University of Bern
Conditions
(from sponsor)		 HIV, Drug Resistance, Drug Drug Interaction
Enrollment 210 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov