Clinical Trials in Switzerland / NCT06037564
Enrolling by invitation Phase 4

B-free Multistage Trial

NCT06037564 · tracked via the Priya Life Science Switzerland tracker
Phase
Phase 4
Started
2023-11-13
Last updated
2024-12-04

Condition(s) studied

HIVDrug ResistanceDrug Drug Interaction

Investigational drug(s) / intervention(s)

DOR/DTG/3TC

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion criteria * Informed consent as documented by signature * Age ≥18 years * Documented HIV-1 infection * On ART including a pharmacological booster (ritonavir or cobicistat) and at least 2 drugs from classes other than NRTI (e.g. non-nucleoside reverse transcriptase inhibitor, integrase-inhibitor, protease inhibitor or entry inhibitor) * History of ART change due to virological failure * HIV-RNA \<50 cp/mL at screening and for at least 24 weeks before screening, one blip with less than 200 cp/mL allowed Exclusion criteria * Creatinine clearance \<30mL/min, calculated using the CKD-EPI formula * Known hypersensitivity, allergy, or intolerance to DOR, DTG, or 3TC * Presence of major drug resistance mutations against DTG (G118R, G140R, Q148H, Q148K, Q148R, R263K) or DOR (V106A, Y188L, F227C, F227L, M230L, Y318F) according to IAS-USA in individual cumulative resistance analyses. Patients without available resistance testing should not be excluded if no resistance to DTG and/or DOR is assumed based on ART history. * Concomitant use of drugs that decrease DTG or DOR blood concentrations * Chronic hepatitis B infection, defined as a positive hepatitis B surface antigen (HBsAg) at the screening visit * Women who are pregnant or breast-feeding. Women of childbearing potential (women who are not surgically sterilized / hysterectomised and / or post-menopausal for longer than 2 years must have a negative pregnancy test at screening). * Participation in another ART intervention study within the 30 days preceding and during the present study. Qualitative sub-study The same inclusion and exclusion criteria as those listed above will be applied. Fifteen persons who were excluded from the trial based on the exclusion criteria above will be recruited for qualitative interviews. In addition to the criteria mentioned above, individuals who are not fluent in German or French will be excluded from the qualitative sub-study.

Primary outcome measure(s)

Trial sites (8)

FacilityCityRegionStatus
Cantonal Hospital Aarau Aarau Canton of Aargau
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

More Insel Gruppe AG, University Hospital Bern trials in Switzerland

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06037564 on ClinicalTrials.gov ↗ ← All trials in Switzerland