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B-free Multistage Trial
Sponsor: Insel Gruppe AG, University Hospital Bern
Summary
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.
Official title: Booster-free Antiretroviral Therapy for Persons Living With HIV and Multidrug Resistance: A Multicentre Multi-stage Randomized Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
210
Start Date
2023-11-13
Completion Date
2027-09
Last Updated
2024-12-04
Healthy Volunteers
No
Conditions
Interventions
DOR/DTG/3TC
Doravirine 100 mg (Pifeltro®) will be administered once daily in combination with co-formulated dolutegravir/lamivudine 50/300 mg (Dovato®) for a duration of 48 weeks.
Locations (8)
Cantonal Hospital Aarau
Aarau, Canton of Aargau, Switzerland
University Hospital Basel
Basel, Switzerland
Inselgruppe AG
Bern, Switzerland
University Hospital Geneva
Geneva, Switzerland
University of Lausanne Hospitals
Lausanne, Switzerland
Lugano Regional Hospital Lugano
Lugano, Switzerland
Cantonal Hospital of St. Gallen
Sankt Gallen, Switzerland
University Hospital Zürich
Zurich, Switzerland