Status:
ENROLLING_BY_INVITATION
B-free Multistage Trial
Lead Sponsor:
Insel Gruppe AG, University Hospital Bern
Collaborating Sponsors:
Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
University of Bern
Conditions:
HIV
Drug Resistance
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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...
Detailed Description
Life expectancy of persons living with HIV on antiretroviral therapy (ART) is increasing and drug-drug interactions (DDI) with co-medications are becoming a major concern. Individuals who previously e...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
November 13 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT06037564
Start Date
November 13 2023
End Date
September 1 2027
Last Update
December 4 2024
Active Locations (8)
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1
Cantonal Hospital Aarau
Aarau, Canton of Aargau, Switzerland, 5001
2
University Hospital Basel
Basel, Switzerland
3
Inselgruppe AG
Bern, Switzerland, 3010
4
University Hospital Geneva
Geneva, Switzerland