NCT06037564Enrolling by invitationPhase 4
B-free Multistage Trial
Booster-free Antiretroviral Therapy for Persons Living With HIV and Multidrug Resistance: A Multicentre Multi-stage Randomized Trial
Source: ClinicalTrials.gov · Last updated 4 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 210 (estimated)
- First submitted
- 24 Apr 2023
- Start date
- Nov 2023
- Primary completion date
- Oct 2026
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Diseases
- HIV
- NCT number
- NCT06037564
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 210
- From Nov 2023 to the primary completion date, Oct 2026
- 8 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Known hypersensitivity, allergy, or intolerance to DOR, DTG, or 3TC
- Chronic hepatitis B infection, defined as a positive hepatitis B surface antigen (HBsAg) at the screening visit
Lab values
- Creatinine clearance \<30mL/min, calculated using the CKD-EPI formula
Other
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cantonal Hospital Aarau Coordinator of this site? Confirm its status | Aarau | Switzerland | Unknown status |
| University Hospital Basel Coordinator of this site? Confirm its status | Basel | Switzerland | Unknown status |
| Inselgruppe AG Coordinator of this site? Confirm its status | Bern | Switzerland | Unknown status |
| University Hospital Geneva Coordinator of this site? Confirm its status | Geneva | Switzerland | Unknown status |
| University of Lausanne Hospitals Coordinator of this site? Confirm its status | Lausanne | Switzerland | Unknown status |
| Lugano Regional Hospital Lugano Coordinator of this site? Confirm its status | Lugano | Switzerland | Unknown status |
| Cantonal Hospital of St. Gallen Coordinator of this site? Confirm its status | Sankt Gallen | Switzerland | Unknown status |
| University Hospital Zurich Coordinator of this site? Confirm its status | Zurich | Switzerland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.