HIV InfectionsNCT06405464
Cabotegravir Plus Rilpivirine Long-acting Regimen in the Swiss HIV Cohort Study:Uptake, Outcome, and Risk Factors for Treatment Failures
An observational study of HIV Infections, run by University of Zurich at 1 site in Switzerland.
Trial summary
This study aims to characterize Swiss HIV Cohort Study participants initiating the CAB+RPV LA regimen, assess adherence to Swiss label indications, and describe treatment outcomes in this large, multicentre, heterogeneous, high-income setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- VOCABRIA 30Mg Tablet, EDURANT 25Mg Tablet and Cabotegravir Injectable Suspension
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 600 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Mar 2022to 30 Jun 2026
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: The study population consists of SHCS participants initiating the CAB+RPV LA regimen and a matched control population on a SOC oral regimen (including dual drug regimens)
Who may be able to join
- Participant in the SHCS
- All SHCS participants initiating the CAB+RPV LA regimen
- All SHCS participants on SOC oral regimen
Who cannot join
- Not participating in the SHCS
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Zurich
Zurich, 8091
Dominique L Braun, MD, 0041442559196, dominique.braun@usz.ch
Jessy J Duran Ramirez, MSc, 0041446341911, jessy.duranramirez@usz.ch
About this study
Official title: Cabotegravir Plus Rilpivirine Long-acting Regimen in the Swiss HIV Cohort Study: Uptake, Outcome, and Risk Factors for Treatment Failures in a Real-world Setting
This study aims to characterize Swiss HIV Cohort Study participants initiating the CAB+RPV LA regimen, assess adherence to Swiss label indications, and describe treatment outcomes in this large, multicentre, heterogeneous, high-income setting. Moreover, the study aims to assess virological, immunological, demographic, clinical, and behavioural factors associated with viral failure under CAB+RPV LA regimen.
- Conditions
- HIV Infections
- Being tested
- VOCABRIA 30Mg Tablet, EDURANT 25Mg Tablet, Cabotegravir Injectable Suspension, Rilpivirine Injectable Suspension, Intact proviral DNA assay
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VOCABRIA 30Mg TabletDrug
Also called Cabotegravir Tablets
CAB 30 mg Film-coated tablets
EDURANT 25Mg TabletDrug
Also called Rilpivirine Tablets
RPV 25 mg film-coated tablets
Cabotegravir Injectable SuspensionDrug
Also called Vocabria
CAB LA 600 mg prolonged release suspension for injection (3 mL)
Rilpivirine Injectable SuspensionDrug
Also called Rekambys
RPV LA 900 mg prolonged release suspension for injection (3 mL)
Intact proviral DNA assayBiological
HIV-1 latent reservoir size
Full-length sequencingBiological
Proviral DNA
| Study group | Role | What they receive |
|---|---|---|
| Swiss HIV Cohort Study participants on CAB+RPV LA regimen | Swiss HIV Cohort Study participants initiating the CAB+RPV LA regimen Receives: Drug: VOCABRIA 30Mg Tablet; Drug: EDURANT 25Mg Tablet; Drug: Cabotegravir Injectable Suspension; Drug: Rilpivirine Injectable Suspension; Biological: Intact proviral DNA assay; Biological: Full-length sequencing | |
| Swiss HIV Cohort Study participants on a standard of care oral regimen | Matched control population on a standard of care oral regimen Receives: Biological: Intact proviral DNA assay; Biological: Full-length sequencing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of individuals with viral blips
Proportion of individuals with viral blips (defined as one HIV-1 RNA >50 and <400 c/mL with a next HIV-1 RNA <50 copies/ml)
Measured: Month 24
Proportion of individuals with confirmed viral failures
Proportion of individuals with confirmed viral failures (defined as two consecutive HIV-1 RNA ≥ 50 c/mL)
Measured: Month 24
Proportion of individuals switching off CAB+RPV LA to previous or another oral regimen
Proportion of individuals switching off CAB+RPV LA to previous or another oral regimen after HIV-1 RNA levels of >50 to <400 copies/mL and >400 copies/mL
Measured: Month 24
Time to viral failure
Overall time to confirmed viral failures (defined as two consecutive HIV-1 RNA ≥ 50 c/mL)
Measured: Up to month 24
Proportion of participants who discontinue treatment due to drug-related reasons
Proportion of participants who discontinue treatment due drug-related reasons and re-suppression regimens (such as adverse events, confirmed viral failure, low level viremia or low blood concentration measurements) including the choice of re-suppression regimens.
Measured: Month 24
Proportion of participants who discontinue treatment due to drug-unrelated reasons
Proportion of participants who discontinue treatment due drug-unrelated reasons and re-suppression regimens (such as patient wish, death, migration, and loss to follow-up) including the choice of re-suppression regimens.
Measured: Month 24
Proportion of participants by characteristics
- Proportion of participants by socio-demographic and clinical characteristic(s) (e.g., by age, sex, body mass index, race, geographic origin, education, transmission mode, HIV-1 RNA levels, CD4 cell count, duration of HIV-1 infection, HIV-1 subtype, previous regimen, genotypic resistance profile, coinfections, lifestyle variables, and co-medications)
Measured: Month 24
Overall adherence to Swiss label indication in CAB+RPV LA prescriptions
- Overall adherence to Swiss label indication in CAB+RPV LA prescriptions between care providers, such as university hospital versus private physicians, and among nationwide centres
Measured: Month 24
Overall adherence to the proposed injection schedules
- Overall adherence to the proposed injection schedules quantified by deriving an CAB+RPV LA adherence threshold (e.g., accounting for any missed injection, daily oral bridging ART, and delayed injection of +7 days according to the Swiss label indication)
Measured: Month 24
Proportion of participants by treatment adherence category
- Proportion of participants by treatment adherence categories (e.g., optimal, sub-optimal, and poor adherence)
Measured: Month 24
Secondary outcomes (3)
Investigate in-depth factors associated with viral blips and viral failure
Proportion of individuals by risk factor(s) (e.g., by body mass index, race, geographic origin, education, HIV-1 RNA levels, CD4 cell count, duration of HIV-1 infection, HIV-1 subtype, previous regimen, treatment adherence, CAB+RPV LA plasma concentrations measured at time of failure, genotypic resistance profile , lifestyle variables, and co-medications)
Measured: Month 24
Measure intact proviral DNA as potential predictor for viral failure
Measure intact proviral DNA as potential predictor for viral failure among PWH initiating CAB+RPV LA regimen and compare with the matched control population on a SOC oral regimen
Measured: Month 24
Assessment of resistance associated mutations from proviral DNA as potential predictor for viral failure
Assessment of resistance associated mutations from proviral DNA as potential predictor for viral failure among PWH initiating CAB+RPV LA regimen and compare with the matched control population on a SOC oral regimen
Measured: Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study start1 Mar 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss HIV Cohort Study
- Responsible party
- Sponsor
- Investigators
- Jessy J Duran Ramirez, MSc, Principal investigator, Department of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06405464
- Sponsor's protocol ID
- 903_SHCS
- Other IDs
- 222485
- Status last verified
- Apr 2024
- First submitted
- 15 Apr 2024
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cabotegravir Plus Rilpivirine Long-acting Regimen in the Swiss HIV Cohort Study: Uptake, Outcome, and Risk Factors for Treatment Failures in a Real-world Setting
- ClinicalTrials.gov ID
- NCT06405464
- Acronym / sponsor ID
- 903_SHCS
- Conditions
- HIV Infections
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Swiss HIV Cohort Study
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 8 May 2024 (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.
This study aims to characterize Swiss HIV Cohort Study participants initiating the CAB+RPV LA regimen, assess adherence to Swiss label indications, and describe treatment outcomes in this large, multicentre, heterogeneous, high-income setting. Moreover, the study aims to assess virological, immunological, demographic, clinical, and behavioural factors associated with viral failure under CAB+RPV LA regimen.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Swiss HIV Cohort Study participants on CAB+RPV LA regimen | – | Drug: VOCABRIA 30Mg Tablet, Drug: EDURANT 25Mg Tablet, Drug: Cabotegravir Injectable Suspension, Drug: Rilpivirine Injectable Suspension, Biological: Intact proviral DNA assay, Biological: Full-length sequencingSwiss HIV Cohort Study participants initiating the CAB+RPV LA regimen |
| Swiss HIV Cohort Study participants on a standard of care oral regimen | – | Biological: Intact proviral DNA assay, Biological: Full-length sequencingMatched control population on a standard of care oral regimen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of SHCS participants initiating the CAB+RPV LA regimen and a matched control population on a SOC oral regimen (including dual drug regimens)
Key inclusion criteria (3 listed)
- Participant in the SHCS
- All SHCS participants initiating the CAB+RPV LA regimen
- All SHCS participants on SOC oral regimen
Key exclusion criteria (1 listed)
- Not participating in the SHCS
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 |
|---|---|---|
| VOCABRIA 30Mg TabletAlso: Cabotegravir TabletsCAB 30 mg Film-coated tablets | Drug | Swiss HIV Cohort Study participants on CAB+RPV LA regimen |
| EDURANT 25Mg TabletAlso: Rilpivirine TabletsRPV 25 mg film-coated tablets | Drug | Swiss HIV Cohort Study participants on CAB+RPV LA regimen |
| Cabotegravir Injectable SuspensionAlso: VocabriaCAB LA 600 mg prolonged release suspension for injection (3 mL) | Drug | Swiss HIV Cohort Study participants on CAB+RPV LA regimen |
| Rilpivirine Injectable SuspensionAlso: RekambysRPV LA 900 mg prolonged release suspension for injection (3 mL) | Drug | Swiss HIV Cohort Study participants on CAB+RPV LA regimen |
| Intact proviral DNA assayHIV-1 latent reservoir size | Biological | Swiss HIV Cohort Study participants on CAB+RPV LA regimen, Swiss HIV Cohort Study participants on a standard of care oral regimen |
| Full-length sequencingProviral DNA | Biological | Swiss HIV Cohort Study participants on CAB+RPV LA regimen, Swiss HIV Cohort Study participants on a standard of care oral regimen |
Primary outcome
Proportion of individuals with viral blips
Time frame: Month 24
Proportion of individuals with viral blips (defined as one HIV-1 RNA >50 and <400 c/mL with a next HIV-1 RNA <50 copies/ml)
Proportion of individuals with confirmed viral failures
Time frame: Month 24
Proportion of individuals with confirmed viral failures (defined as two consecutive HIV-1 RNA ≥ 50 c/mL)
Proportion of individuals switching off CAB+RPV LA to previous or another oral regimen
Time frame: Month 24
Proportion of individuals switching off CAB+RPV LA to previous or another oral regimen after HIV-1 RNA levels of >50 to <400 copies/mL and >400 copies/mL
Time to viral failure
Time frame: Up to month 24
Overall time to confirmed viral failures (defined as two consecutive HIV-1 RNA ≥ 50 c/mL)
Proportion of participants who discontinue treatment due to drug-related reasons
Time frame: Month 24
Proportion of participants who discontinue treatment due drug-related reasons and re-suppression regimens (such as adverse events, confirmed viral failure, low level viremia or low blood concentration measurements) including the choice of re-suppression regimens.
Proportion of participants who discontinue treatment due to drug-unrelated reasons
Time frame: Month 24
Proportion of participants who discontinue treatment due drug-unrelated reasons and re-suppression regimens (such as patient wish, death, migration, and loss to follow-up) including the choice of re-suppression regimens.
Proportion of participants by characteristics
Time frame: Month 24
- Proportion of participants by socio-demographic and clinical characteristic(s) (e.g., by age, sex, body mass index, race, geographic origin, education, transmission mode, HIV-1 RNA levels, CD4 cell count, duration of HIV-1 infection, HIV-1 subtype, previous regimen, genotypic resistance profile, coinfections, lifestyle variables, and co-medications)
Overall adherence to Swiss label indication in CAB+RPV LA prescriptions
Time frame: Month 24
- Overall adherence to Swiss label indication in CAB+RPV LA prescriptions between care providers, such as university hospital versus private physicians, and among nationwide centres
Overall adherence to the proposed injection schedules
Time frame: Month 24
- Overall adherence to the proposed injection schedules quantified by deriving an CAB+RPV LA adherence threshold (e.g., accounting for any missed injection, daily oral bridging ART, and delayed injection of +7 days according to the Swiss label indication)
Proportion of participants by treatment adherence category
Time frame: Month 24
- Proportion of participants by treatment adherence categories (e.g., optimal, sub-optimal, and poor adherence)
3 secondary outcomes
Investigate in-depth factors associated with viral blips and viral failure
Time frame: Month 24
Measure intact proviral DNA as potential predictor for viral failure
Time frame: Month 24
Assessment of resistance associated mutations from proviral DNA as potential predictor for viral failure
Time frame: Month 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Individual participant dataSharing planned: Undecided
Related trials for HIV Infections
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
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. This study is not recruiting at the moment.
Jessy J Duran Ramirez, MSc principal investigator
Department of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections, run by University of Zurich at 1 site 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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dominique L Braun, MD (0041442559196, dominique.braun@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of individuals with viral blips (time frame: Month 24). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 May 2024.