HIVPhase 4B-freeNCT06037564
B-free Multistage Trial
A Phase 4 study testing DOR/DTG/3TC in people with HIV and Drug Resistance, run by Insel Gruppe AG, University Hospital Bern at 8 sites in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV, Drug Resistance, Drug Drug Interaction
- What is being tested?
- DOR/DTG/3TC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 8 sitesSwitzerland
- Study dates
- 13 Nov 2023to Sep 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
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- 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.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
Switzerland8 sites
Cantonal Hospital Aarau
Aarau, Canton of Aargau, 5001
University Hospital Basel
Basel
Inselgruppe AG
Bern, 3010
University Hospital Geneva
Geneva
University of Lausanne Hospitals
Lausanne
Lugano Regional Hospital Lugano
Lugano
Cantonal Hospital of St. Gallen
Sankt Gallen
University Hospital Zürich
Zurich
About this study
Official title: Booster-free Antiretroviral Therapy for Persons Living With HIV and Multidrug Resistance: A Multicentre Multi-stage Randomized Trial
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.
Read the 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 experienced virological failure are at risk of DDI as they are generally treated with ritonavir- or cobicistat-boosted ART. The high potency as well as the favorable safety and pharmacokinetic profile of new antiretroviral drugs, including dolutegravir (DTG) and doravirine (DOR), support their evaluation as part of un-boosted therapy for individuals with a history of virological failure. In this adaptive trial within the Swiss HIV Cohort Study (SHCS) and partner clinics in the Netherlands, the investigators aim to evaluate the efficacy and acceptability of the booster-free regimen DOR/DTG/3TC for treatment-experienced individuals.
- Conditions
- HIV, Drug Resistance, Drug Drug Interaction
- Being tested
- DOR/DTG/3TC
- Keywords
- HIV, Doravirine, Dolutegravir, Drug resistance, Drug-drug interaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DOR/DTG/3TCDrug
Also called Doravirine (Pifeltro®) + Dolutegravir/Lamivudine (Dovato®)
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 group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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. Receives: Drug: DOR/DTG/3TC |
| Control | No intervention | Participants randomized to the control arm will continue to take their fully suppressive ART at baseline. The following selection of treatment combinations could be encountered in the control group (among others): * Once-daily co-formulated elvitegravir 150 mg, cobicistat 150 mg, tenofovir alafenamide 10 mg, emtricitabine 200 mg (Genvoya®) and darunavir 800 mg (e.g. Darunavir Mylan®) * Once-daily co-formulated darunavir 800 mg, cobicistat 150 mg, tenofovir alafenamide 10 mg, emtricitabine 200 mg (Symtuza ®) and DTG 50 mg (Tivicay ®) * Once-daily DTG 50 mg (Tivicay®), darunavir 800 mg (e.g. Darunavir Mylan®), and ritonavir 100 mg (Norvir®) * Etravirine 200 mg twice daily (Intelence®), raltegravir 400 mg twice daily (Isentress®),darunavir 800 mg once daily (e.g. Darunvair Mylan®) and ritonavir 100 mg once daily (Norvir®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Loss of viral suppression
Difference in the proportion of individuals with an HIV-RNA ≥50 cp/mL at 48 weeks between the treatment arms.
Measured: Week 48
Secondary outcomes (17)
Changes in DDI score from week 0 to 48
Using the University of Liverpool Drug Database (https://www.hiv-druginteractions.org/), the prescribed ART and co-medications will be categorized as red flag (3 points) for severe DDIs when co-administration is contraindicated, amber flag (2 points) for potential clinically significant DDIs manageable by dose adjustment or clinical monitoring, yellow flag (1 point) for DDIs of weak clinical relevance with no need of a priori dosage adjustment or monitoring, and a green flag (0 points) for no interactions. Amber flag DDIs will be downgraded to 1 point if there is evidence that the DDI was managed correctly (i.e. DTG administered 2 hours before or 6 hours after taking divalent cations). The sum of all points at visit 6, week 48 will be compared to baseline.
Measured: Week 0 and 48
Patient report outcomes concerning changes in treatment satisfaction between baseline and 48 weeks, as determined using the HIV Treatment Satisfaction Questionnaire HIVTSQc (change version).
The investigators will assess changes in treatment satisfaction between week 0 and 48 using the validated HIV Treatment Satisfaction Questionnaire HIVTSQc (change version).
Measured: Week 0 to 48
Proportion of patients experiencing confirmed virological failure
Proportion of patients experiencing confirmed virological failure, defined as 2 consecutive plasma HIV viral loads ≥200 copies/mL
Measured: Week 48
Proportion of individuals detected with new drug resistance
Proportion of individuals experiencing impairment / loss of future drug options throughout the study period, defined as new detection of resistance-associated mutations against DOR, DTG, 3TC (intervention-arm) or against the components of the ART regimen that the virus was considered to be sensitive to at randomization (based on historic resistance testing or treatment history; control-arm).
Measured: Week 0 to 48
Proportion of individuals with any moderate (orange flag) or severe (red flag) DDI
Proportion of individuals with any moderate (orange flag) or severe (red flag) DDI at any study visit between baseline and week 48, based on the results from the Liverpool drug interaction database (www.hiv-druginteractions.org).
Measured: Week 0 to 48
Proportion of patients with DDI leading to suboptimal management of comorbidities
Proportion of patients with DDI leading to suboptimal management of comorbidities between baseline and week 48, as reported by the cohort physician.
Measured: Week 0 and 48
Patient report outcomes concerning differences in quality of life between both groups at week 48 assessed by the World Health Organization Quality-of-Life- HIV Bref (WHOQOL-HIV BREF) questionnaire
Differences in quality of life between both groups at week 48, assessed using the World Health Organization Quality-of-Life- HIV Bref (WHOQOL-HIV BREF) questionnaire
Measured: Week 48
Patient report outcomes concerning differences in treatment satisfaction between both groups assessed by HIV Treatment Satisfaction Questionnaires
The investigators will assess the differences in treatment satisfaction between both groups at week 48, as determined using the validated HIV Treatment Satisfaction Questionnaires HIVTSQ.
Measured: Week 48
Proportion of individuals reporting depression assessed by Patient Health Questionnaire-9
Depression will be assessed at baseline and week 48, assessed using the Patient Health Questionnaire-9 (PHQ-9)
Measured: Week 0 and 48
Changes in intact proviral HIV-DNA levels
Changes in intact proviral HIV-DNA levels in peripheral blood mononuclear cells (PBMCs) between baseline and week 48. Stored PBMC samples will be used to determine HIV-DNA levels by a digital droplet PCR (ddPCR) assay using the RAINDANCE system.
Measured: Week 0 to 48
Proportion of individuals who develop a detectable HBV viral load
Proportion of individuals with a positive anti-HBc and negative anti-HBs ("anti-HBc alone") who develop a detectable HBV viral load (>50 IU/mL) at weeks 24 and 48.
Measured: Weeks 24 and 48
Cumulative cost of all ART drugs used
The 48-weeks cumulative cost of the received ART regimen will be calculated using prices published by the Federal Office of Public Health (https://www.spezialitaetenliste.ch/ShowPreparations.aspx).
Measured: Week 0 to 48
Perception of the trial and/or of HIV-related research in general assessed by qualitative interviews in a subset of approximately 30 trial participants
Perception of the trial and/or of HIV-related research in general.
Measured: Week 0 and 48
Acceptability conditions of participation in the trial assessed by qualitative interviews in a subset of approximately 30 trial participants
Acceptability conditions, understood as all barriers and facilitators to be involved in a trial.
Measured: Week 0 and 48
Needs regarding the booster-free regimen or regarding ART in general assessed by qualitative interviews in a subset of approximately 30 trial participants
Needs regarding the booster-free regimen or regarding ART in general for participants included in the observational cohort.
Measured: Week 0 and 48
Expectations regarding the booster-free regimen or regarding ART in general assessed by qualitative interviews in a subset of approximately 30 trial participants
Expectations regarding the booster-free regimen or regarding ART in general for participants included in the observational cohort.
Measured: Week 0 and 48
Perspectives on how the participants' current and anticipated needs can be assessed by qualitative interviews in a subset of approximately 30 trial participants
Perspectives on how the participants' current and anticipated needs can be addressed by research.
Measured: Week 0 and 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2023
- Study start13 Nov 2023
- Primary completionOct 2026 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multi-stage, randomized, multicenter, open-label non-inferiority trial with active control
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland, University of Bern
- Responsible party
- Sponsor
- Investigators
- Gilles Wandeler, Prof, Principal investigator, Inselspital, Bern, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06037564
- Sponsor's protocol ID
- B-free trial - Stage 1
- Acronym
- B-free
- Status last verified
- Dec 2024
- First submitted
- 24 Apr 2023
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ballif M, Braun D, Calmy A, Bernasconi E, Cavassini M, Tissot F, Stoeckle M, Schmid P, Fux CA, Van der Valk M, Brinkman K, Mudrikova T, Bonnet F, Leleux O, Saude M, Hirter D, Schwab N, Limacher A, Rintelen F, Kouyos R, Haerry D, Zambrano SC, Egloff M, Akre C, Peytremann-Bridevaux I, Rauch A, Wandeler G, Surial B. Booster-free anti-retroviral therapy for persons living with HIV and multidrug resistance (B-Free): protocol for a multicentre, multistage, randomised, controlled, non-inferiority trial. BMJ Open. 2024 Nov 21;14(11):e094912. doi: 10.1136/bmjopen-2024-094912.
PubMed 39578038
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Booster-free Antiretroviral Therapy for Persons Living With HIV and Multidrug Resistance: A Multicentre Multi-stage Randomized Trial
- ClinicalTrials.gov ID
- NCT06037564
- Acronym / sponsor ID
- B-free / B-free trial - Stage 1
- Conditions
- HIV, Drug Resistance, Drug Drug Interaction
- Keywords
- HIV, Doravirine, Dolutegravir, Drug resistance, Drug-drug interaction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland, University of Bern
- Study start
- 13 Nov 2023 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 14 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 experienced virological failure are at risk of DDI as they are generally treated with ritonavir- or cobicistat-boosted ART. The high potency as well as the favorable safety and pharmacokinetic profile of new antiretroviral drugs, including dolutegravir (DTG) and doravirine (DOR), support their evaluation as part of un-boosted therapy for individuals with a history of virological failure. In this adaptive trial within the Swiss HIV Cohort Study (SHCS) and partner clinics in the Netherlands, the investigators aim to evaluate the efficacy and acceptability of the booster-free regimen DOR/DTG/3TC for treatment-experienced individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Multi-stage, randomized, multicenter, open-label non-inferiority trial with active control
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: DOR/DTG/3TCDoravirine 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. |
| Control | No intervention | –Participants randomized to the control arm will continue to take their fully suppressive ART at baseline. The following selection of treatment combinations could be encountered in the control group (among others): * Once-daily co-formulated elvitegravir 150 mg, cobicistat 150 mg, tenofovir alafenamide 10 mg, emtricitabine 200 mg (Genvoya®) and darunavir 800 mg (e.g. Darunavir Mylan®) * Once-daily co-formulated darunavir 800 mg, cobicistat 150 mg, tenofovir alafenamide 10 mg, emtricitabine 200 mg (Symtuza ®) and DTG 50 mg (Tivicay ®) * Once-daily DTG 50 mg (Tivicay®), darunavir 800 mg (e.g. Darunavir Mylan®), and ritonavir 100 mg (Norvir®) * Etravirine 200 mg twice daily (Intelence®), raltegravir 400 mg twice daily (Isentress®),darunavir 800 mg once daily (e.g. Darunvair Mylan®) and ritonavir 100 mg once daily (Norvir®) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DOR/DTG/3TCAlso: Doravirine (Pifeltro®) + Dolutegravir/Lamivudine (Dovato®)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. | Drug | Intervention |
Primary outcome
Loss of viral suppression
Time frame: Week 48
Difference in the proportion of individuals with an HIV-RNA ≥50 cp/mL at 48 weeks between the treatment arms.
17 secondary outcomes
Changes in DDI score from week 0 to 48
Time frame: Week 0 and 48
Patient report outcomes concerning changes in treatment satisfaction between baseline and 48 weeks, as determined using the HIV Treatment Satisfaction Questionnaire HIVTSQc (change version).
Time frame: Week 0 to 48
Proportion of patients experiencing confirmed virological failure
Time frame: Week 48
Proportion of individuals detected with new drug resistance
Time frame: Week 0 to 48
Proportion of individuals with any moderate (orange flag) or severe (red flag) DDI
Time frame: Week 0 to 48
Proportion of patients with DDI leading to suboptimal management of comorbidities
Time frame: Week 0 and 48
Patient report outcomes concerning differences in quality of life between both groups at week 48 assessed by the World Health Organization Quality-of-Life- HIV Bref (WHOQOL-HIV BREF) questionnaire
Time frame: Week 48
Patient report outcomes concerning differences in treatment satisfaction between both groups assessed by HIV Treatment Satisfaction Questionnaires
Time frame: Week 48
Proportion of individuals reporting depression assessed by Patient Health Questionnaire-9
Time frame: Week 0 and 48
Changes in intact proviral HIV-DNA levels
Time frame: Week 0 to 48
Proportion of individuals who develop a detectable HBV viral load
Time frame: Weeks 24 and 48
Cumulative cost of all ART drugs used
Time frame: Week 0 to 48
Perception of the trial and/or of HIV-related research in general assessed by qualitative interviews in a subset of approximately 30 trial participants
Time frame: Week 0 and 48
Acceptability conditions of participation in the trial assessed by qualitative interviews in a subset of approximately 30 trial participants
Time frame: Week 0 and 48
Needs regarding the booster-free regimen or regarding ART in general assessed by qualitative interviews in a subset of approximately 30 trial participants
Time frame: Week 0 and 48
Expectations regarding the booster-free regimen or regarding ART in general assessed by qualitative interviews in a subset of approximately 30 trial participants
Time frame: Week 0 and 48
Perspectives on how the participants' current and anticipated needs can be assessed by qualitative interviews in a subset of approximately 30 trial participants
Time frame: Week 0 and 48
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
- Derived from this study: PubMed 39578038Ballif M, Braun D, Calmy A, Bernasconi E, Cavassini M, Tissot F, Stoeckle M, Schmid P, Fux CA, Van der Valk M, Brinkman K, Mudrikova T, Bonnet F, Leleux O, Saude M, Hirter D, Schwab N, Limacher A, Rintelen F, Kouyos R, Haerry D, Zambrano SC, Egloff M, Akre C, Peytremann-Bridevaux I, Rauch A, Wandeler G, Surial B. Booster-free anti-retroviral therapy for persons living with HIV and multidrug resistance (B-Free): protocol for a multicentre, multistage, randomised, controlled, non-inferiority trial. BMJ Open. 2024 Nov 21;14(11):e094912. doi: 10.1136/bmjopen-2024-094912.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gilles Wandeler, Prof principal investigator
Inselspital, Bern, Switzerland
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing DOR/DTG/3TC in people with HIV and Drug Resistance, run by Insel Gruppe AG, University Hospital Bern at 8 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Loss of viral suppression (time frame: Week 48). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06037564, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2024.