HIV-Therapie ohne Booster
bei Personen mit vorbestehenden HIV-Resistenzen
B-Free Studie
Traitement contre le VIH sans booster
pour les personnes avec résistances médicamenteuses préexistantes
Etude B-Free
Studio B-Free
Terapia anti-HIV senza potenziatore (booster)
in soggetti con resistenze preesistenti all’HIV
B-Free Study
Booster-free HIV therapy
for persons with pre-existing HIV resistance
Information
Why is your participation in the study important?
Life expectancy of people with HIV is increasing due to improved antiretroviral treatment options. However, older people are more likely to develop comorbidities for which additional medication is necessary.
Antiretroviral drugs can interfere with other medications (so-called interactions). These interactions occur most commonly with treatments that contain a booster (ritonavir or cobicistat). In the Swiss HIV Cohort Study (SHCS), 3/4 of problematic drug interactions occur in individuals who receive such boosted therapies.
Antiretroviral drugs dolutegravir, lamivudine and doravirine are approved in Switzerland and have a low potential for interactions with other drug.
To date, the combination of dolutegravir, lamivudine and doravirine has not been studied for use in people with HIV and preexisting drug resistances. In this study, we aim to evaluate whether this new combination of antiretroviral drugs is as effective as your current therapy for the treatment of HIV.
In addition, we would like to assess the influence of the antiretroviral therapy on your quality of life and treatment satisfaction through the course of the study.
A subset of individuals will also have the possibility to participate in two interviews. In these interviews, you will be able to share your perception and expectations towards antiretroviral therapy and research in general, and to tell us about the acceptability of such a clinical study. All your information will be treated confidentially.
Start: September 2023
Duration: 1 year
Number of visits: 8 (including your regular visits)
Participants: 210 participants in Switzerland and the
Netherlands, age ≥18 years, on boosted-ART, with history of virological failure
Randomization into 2 groups of equal size
Intervention group: Booster-free antiretroviral therapy with dolutegravir, lamivudine and doravirine (2 pills to be taken once daily)
Control group: Continue current antiretroviral therapy
Process
Signing consent form
Randomization into the intervention or the control group
Treatment satisfaction and quality of life
Blood and urine sample
Physical examination
Assessment of further medication intake
Adverse events
Adherence to medication
In-depth interview, if agreed (additional 60-90 min)
*can be done by phone
Current Status
33
Screened
31
Randomized
Screened: Number of individuals who were examined
to determine if they are suitable for the study.
Randomized: Number of individuals
who were included in the study.
Study centers
Cantonal Hospital Aarau
Principal Investigator: Christoph Fux
University Hospital Basel
Principal Investigator: Marcel Stöckle
University Hospital Bern (Insel)
Principal Investigator: Bernard Surial
University Hospital Geneva (HUG)
Principal Investigator: Alexandra Calmy
University Hospital Lausanne (CHUV)
Principal Investigator: Matthias Cavassini
Regional Hospital Lugano
Principal Investigator: Enos Bernasconi
Cantonal Hospital of St. Gallen
Principal Investigator: Patrick Schmid
University Hospital Zürich
Principal Investigator: Dominique Braun