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ENROLLING BY INVITATION
NCT06037564
PHASE4

B-free Multistage Trial

Sponsor: Insel Gruppe AG, University Hospital Bern

View on ClinicalTrials.gov

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

Interventions

DRUG

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