Human Immunodeficiency VirusCABO-CHANCENCT06518408
A Real-life Study of the Use of Cabotegravir Plus Rilpivirine Long-acting in ART-experienced Pre-treated People With HIV
An observational study of Human Immunodeficiency Virus, run by University Hospital Virgen de las Nieves at 15 sites in Spain.
Trial summary
The CABOTEGRAVIR Long Acting + RILPIVIRENE Long Acting regimen was currently endorsed by guidelines worldwide as an option for the Treatment of HIV-1 Infection, however collecting real-world data closer to clinical practice use is still necessary. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Human Immunodeficiency Virus
- What is being tested?
- Cabotegravir Injectable Product and Rilpivirine Injectable Product
- Type of treatment
- Injection or infusion
- How many people
- 287 participants
- Where
- 15 sitesSpain
- Study dates
- 1 Jun 2023to 30 Sep 2027
- Phase
- Observational
- 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
Study population: Virologically suppressed PWH, who switch to CAB LA + RPV LA Q2M (EU SmPC) from June 2023 to March 2024. Participants must meet all inclusion and no exclusion criteria. CAB LA + RPV LA injection may be preceded by an optional oral lead-in (OLI) according to the physician's judgement for 28 days
Inclusion Criteria: participants are required to meet all the following inclusion criteria to be eligible for PWH.
- Aged 18 years or older at the time of signing the informed consent.
- Virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen
- Documented evidence of plasma HIV-1 RNA measurements <50 copies/mL in the 6 months prior to Screening (1x blip is allowed).
- Ability to understand informed consent form (ICF) and other relevant regulatory documents.
- Prior to starting CAB LA + RPV LA injections, HIV physicians should have carefully selected patients who agree to the required injection schedule and counsel patients about the importance of adherence to scheduled dosing visits to help maintain viral suppression and reduce the risk of viral rebound and potential development of resistance with missed doses.
- A female subject is eligible to participate if she is not pregnant (as confirmed by a negative serum or urine hCG test ) and not lactating. Females of childbearing potential will be required to use a highly effective method of contraception.
Exclusion Criteria: participants will be excluded from the trial if there is evidence of any of the following criteria at screening or check-in, as appropriate.
- Within 6 months prior to Screening, any plasma HIV-1 RNA measurement ≥50 copies/mL or within the 6 to 12-month window prior to Screening, any plasma HIV-1 RNA measurement >200 copies/mL, or 2 or more plasma HIV-1 RNA measurements ≥50 copies/mL.
- Previous antiretroviral treatment interruption during the last 6 months or treatment interruptions for more than a month.
- Present or past evidence of viral resistance to agents of the NNRTI or INI class or prior treatment failure with agents of NNRTI or INSTI class
- Any contraindication for CAB LA, RPV LA, oral Cabotegravir or Rilpivirine (see EU SmPC).
- Evidence of Hepatitis B virus (HBV) infection based on the results of testing at Screening for Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (anti-HBc), Hepatitis B surface antibody (anti-HBs) and HBV DNA as follows:
- Participants positive for HBsAg are excluded.
- Participants negative for anti-HBs but positive for anti-HBc (negative HBsAg status), whether negative or positive for HBV DNA, are excluded.
- Note: Participants positive for anti-HBc (negative HBsAg status) and positive for anti-HBs (past and/or current evidence) are immune to HBV and are not excluded.
- Participants treated with entecavir are not excluded.
- Any condition that does not recommend intramuscular injections in the gluteal muscle.
- Pregnancy or breastfeeding women, or with the desire to become pregnant soon.
- Current use of concomitant treatment with prohibited medication
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Spain15 sites
Hospital Universitario Puerto Real, INIBICA,
Cadiz
Jerez de la Frontera University Hospital
Cadiz
Reina Sofía University Hospital
Córdoba
Hospital Universitario Virgen de Las Nieves
Granada, Andalusia, 18008
Hospital Campus de la Salud
Granada, 18014
Hospital Comarcal Santa Ana de Motril
Granada
Complejo Hospitalario de Jaén,
Jaén
Hospital San Pedro
Logroño, La Rioja, 26006
Hu La Princesa
Madrid
Ramon Y Cajal
Madrid
Hospital Reina Sofía
Murcia, Murcia, 30003
Hospital General Universitario Santa Lucía
Murcia
Hospital de Son Llàtzer
Palma de Mallorca
Hospital Universitario de Canarias
Santa Cruz de Tenerife
Hospital Clínico Universitario Lozano Blesa
Zaragoza
About this study
The CABOTEGRAVIR Long Acting + RILPIVIRENE Long Acting regimen was currently endorsed by guidelines worldwide as an option for the Treatment of HIV-1 Infection, however collecting real-world data closer to clinical practice use is still necessary. This study also registers some immunological, metabolic,anti-inflammatory parameters and fat distribution analysis to observe a hypothetical improvement on these parameters.
Psychosocial aspects are also very important in these patients as these patients may suffer social stigma, and therefore suffer certain psychological disorders. Patient experience data will be assessed through PROs and bespoke single-item questions to collect patient perception of treatment and register psychosocial aspects related to their health status.
- Conditions
- Human Immunodeficiency Virus
- Being tested
- Cabotegravir Injectable Product, Rilpivirine Injectable Product
- Keywords
- HIV, Long-Acting, Cabotegravir, Rilpivirine
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cabotegravir Injectable ProductDrug
Also called VOCABRIA (cabotegravir)
long-acting regimen dosed every 2-months
Rilpivirine Injectable ProductDrug
Also called REKAMBYS (rilpivirine)
long-acting regimen dosed every 2-months
| Study group | Role | What they receive |
|---|---|---|
| study group | Patients enrolled who switch to receive Cabotegravir long acting plus Rilpivirine long acting intramuscular injection every 2 months Receives: Drug: Cabotegravir Injectable Product; Drug: Rilpivirine Injectable Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants switching treatment to CAB LA + RPV LA regimen dosed every 2-months with plasma HIV-1 RNA ≥50 at month 12
Proportion of participants suppressed on stable oral ART that switched to CAB LA + RPV LA with plasma HIV-1 RNA ≥50 copies/mL at month 12
Measured: 12 months
Secondary outcomes (26)
Number of participants switching treatment to CAB LA + RPV LA regimen dosed every 2-months with plasma HIV-1 RNA ≥50 at month 24
Proportion of participants suppressed on stable oral ART that switch to CAB LA + RPV LA with plasma HIV-1 RNA ≥50 copies/mL at month 24
Measured: 24 months
Number of participants switching treatment to CAB LA + RPV LA regimen dosed every 2-months with plasma HIV-1 RNA ≥50 at months 12 and 24
Proportion of participants suppressed on stable oral ART that switch to CAB LA + RPV LA with plasma HIV-1 RNA <50 copies/mL at months 12 and 24
Measured: 12 and 24 months
Number of episodes of plasma HIV-1 RNA ≥50 copies/mL
Number of episodes of plasma HIV-1 RNA ≥50 copies/mL that do not meet the criteria for confirmed virological failure
Measured: 24 months
Number of participants experiencing confirmed virologic failure at months 12 and 24.
Proportion of participants experiencing confirmed virologic failure (CVF: two consecutive plasma HIV-1 RNA ≥200 copies/mL) at months 12 and 24.
Measured: 12 and 24 months
Change from baseline in the mean lymphocyte subpopulations
Changes from baseline in the mean values of CD4, CD8 and CD4/CD8 ratio of participants switching to CAB LA + RPV LA at months 12 and 24.
Measured: 12 and 24 months
Incidence and severity of adverse events
Proportion of emergence of adverse events, laboratory abnormalities and discontinuation rates due to adverse events. Includes severity evaluation of those
Measured: 24 months
Description of reasons for discontinuation from CAB LA + RPV LA over 24 months
Reasons recorded for discontinuation of the study intervention during the follow-up
Measured: 24 months
Number of reports fo adverse events over 24 months
Persistence over 24 months of adverse events, including injection site reactions (ISR), after switching to CAB LA + RPV LA
Measured: 24 months
Description of reasons for switching to CAB LA + RPV LA
Reasons recorded for switching to the study intervention
Measured: 24 months
Changes in absolute values from baseline over 24 months in metabolic control parameters: glucose
changes from baseline over 24 months and the proportion by patient subgroup with significant changes: in metabolic control parameters: glucose
Measured: 24 months
Changes in absolute values from baseline over 24 months in metabolic control parameters: lipids
changes from baseline over 24 months and the proportion by patient subgroup with significant changes: in metabolic control parameters: lipids.
Measured: 24 months
Changes in absolute values from baseline over 24 months in metabolic control parameters: weight
changes from baseline over 24 months and the proportion by patient subgroup with significant changes: in metabolic control parameters: weight.
Measured: 24 months
Changes in absolute values from baseline over 24 months in metabolic control parameters: waist circumference.
changes from baseline over 24 months and the proportion by patient subgroup with significant changes: in metabolic control parameters: waist circumference.
Measured: 24 months
Changes in absolute values from baseline over 24 months in metabolic control parameters: BMI
changes from baseline over 24 months and the proportion by patient subgroup with significant changes in metabolic control parameters: BMI (kg/m^2).
Measured: 24 months
Changes in pro-inflammatory biomarkers (D-Dimmer) from baseline over 24 months in a subgroup of participants
Assesment and description in a subgroup of study participants of the change of pro-inflammatory biomarkers (D-Dimmer) after switching to CAB LA+ RPV LA through the study.
Measured: 24 months
Changes in pro-inflammatory biomarkers (fibrinogen) from baseline over 24 months in a subgroup of participants
Assesment and description in a subgroup of study participants of the change of pro-inflammatory biomarkers (fibrinogen) after switching to CAB LA+ RPV LA through the study.
Measured: 24 months
Changes in pro-inflammatory biomarkers (CRP) from baseline over 24 months in a subgroup of participants
Assesment and description in a subgroup of study participants of the change of pro-inflammatory biomarkers (CRP) after switching to CAB LA+ RPV LA through the study.
Measured: 24 months
Changes in pro-inflammatory biomarkers (IL-6) from baseline over 24 months in a subgroup of participants
Assesment and description in a subgroup of study participants of the change of pro-inflammatory biomarkers (IL-6) after switching to CAB LA+ RPV LA through the study.
Measured: 24 months
Changes in creatinine values from baseline over 24 months
Changes from baseline over 24 months in creatinine (mg/dL) values after switching to CAB LA + RPV LA
Measured: 24 months
Changes in hepatic values (Albumine) from baseline over 24 months
Changes from baseline over 24 months in hepatic values (Albumine) in g/dL after switching to CAB LA + RPV LA
Measured: 24 months
Changes in hepatic values (Alanine transaminase (ALT), Aspartate transaminase (AST) and Alkaline phosphatase (ALP)) from baseline over 24 months
Changes from baseline over 24 months in hepatic values (Alanine transaminase (ALT), Aspartate transaminase (AST) and Alkaline phosphatase (ALP)) in U/L after switching to CAB LA + RPV LA
Measured: 24 months
Changes in preference values from baseline over 24 months about ART
Rate of ART preference of LA-injected vs. oral ART at months12 and 24 and description of reasons
Measured: 12 and 24 months
Changes in patient reported outcomes questionnaires from baseline over 24 months: WHOQOL-HIV-BREF
Changes from baseline in domains of PROs: World Health Organization Quality of Life, on Human Immunodeficiency Virus, brief version (WHOQOL-HIV-BREF) scale over 24 months and the proportion by patient subgroup with significant changes. MIN VALUE 26- MAX VALUE 130. Higher scores mean better quality of life.
Measured: 24 months
Changes in patient reported outcomes questionnaires from baseline over 24 months: HSSS
Changes from baseline in domains of PROs: adapted HIV Stigma Scale for use in Spain (HSSS) scale over 24 months and the proportion by patient subgroup with significant changes. Scores can range from 40 to 160 [1 x 40 items to 4 x 40 items]. Higher scores indicate greater feelings of stigma
Measured: 24 months
Changes in patient reported outcomes questionnaires from baseline over 24 months: PSQI
Changes from baseline in domains of PROs: Pittsburgh Sleep Quality Index (PSQI) scale over 24 months and the proportion by patient subgroup with significant changes. Score has a possible range of 0-21 points. Higher scores means better sleep quality
Measured: 24 months
Incidence of adherence to scheduled interventions over 24 months
- Number and percentage of total injections within ±7-day dosing window
- Number and percentage of missed injections.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2024
- Study start1 Jun 2023
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Immunodeficiency VirusStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 287 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Virgen de las Nieves
- Sponsor type
- University, hospital or other
- Collaborators
- ViiV Healthcare
- Responsible party
- Principal investigator, Carmen Hidalgo Tenorio, University Hospital Virgen de las Nieves
- Investigators
- CARMEN HIDALGO, PhD, Principal investigator, HU Virgen de las Nieves
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06518408
- Sponsor's protocol ID
- FIB-CAB-2023-02
- Acronym
- CABO-CHANCE
- Status last verified
- Jul 2024
- First submitted
- 9 Jul 2024
- Last updated
- 24 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-life Study of the Use of Cabotegravir Plus Rilpivirine Long-acting in ART-experienced Pre-treated People With HIV
- ClinicalTrials.gov ID
- NCT06518408
- Acronym / sponsor ID
- CABO-CHANCE / FIB-CAB-2023-02
- Conditions
- Human Immunodeficiency Virus
- Keywords
- HIV, Long-Acting, Cabotegravir, Rilpivirine
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 287 participants (actual)
- Lead sponsor
- University Hospital Virgen de las NievesUniversity, hospital or other
- Collaborators
- ViiV Healthcare
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 24 Jul 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.
The CABOTEGRAVIR Long Acting + RILPIVIRENE Long Acting regimen was currently endorsed by guidelines worldwide as an option for the Treatment of HIV-1 Infection, however collecting real-world data closer to clinical practice use is still necessary. This study also registers some immunological, metabolic,anti-inflammatory parameters and fat distribution analysis to observe a hypothetical improvement on these parameters.
Psychosocial aspects are also very important in these patients as these patients may suffer social stigma, and therefore suffer certain psychological disorders. Patient experience data will be assessed through PROs and bespoke single-item questions to collect patient perception of treatment and register psychosocial aspects related to their health status.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study group | – | Drug: Cabotegravir Injectable Product, Drug: Rilpivirine Injectable ProductPatients enrolled who switch to receive Cabotegravir long acting plus Rilpivirine long acting intramuscular injection every 2 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Virologically suppressed PWH, who switch to CAB LA + RPV LA Q2M (EU SmPC) from June 2023 to March 2024. Participants must meet all inclusion and no exclusion criteria. CAB LA + RPV LA injection may be preceded by an optional oral lead-in (OLI) according to the physician's judgement for 28 days
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 |
|---|---|---|
| Cabotegravir Injectable ProductAlso: VOCABRIA (cabotegravir)long-acting regimen dosed every 2-months | Drug | study group |
| Rilpivirine Injectable ProductAlso: REKAMBYS (rilpivirine)long-acting regimen dosed every 2-months | Drug | study group |
Primary outcome
Number of participants switching treatment to CAB LA + RPV LA regimen dosed every 2-months with plasma HIV-1 RNA ≥50 at month 12
Time frame: 12 months
Proportion of participants suppressed on stable oral ART that switched to CAB LA + RPV LA with plasma HIV-1 RNA ≥50 copies/mL at month 12
26 secondary outcomes
Number of participants switching treatment to CAB LA + RPV LA regimen dosed every 2-months with plasma HIV-1 RNA ≥50 at month 24
Time frame: 24 months
Number of participants switching treatment to CAB LA + RPV LA regimen dosed every 2-months with plasma HIV-1 RNA ≥50 at months 12 and 24
Time frame: 12 and 24 months
Number of episodes of plasma HIV-1 RNA ≥50 copies/mL
Time frame: 24 months
Number of participants experiencing confirmed virologic failure at months 12 and 24.
Time frame: 12 and 24 months
Change from baseline in the mean lymphocyte subpopulations
Time frame: 12 and 24 months
Incidence and severity of adverse events
Time frame: 24 months
Description of reasons for discontinuation from CAB LA + RPV LA over 24 months
Time frame: 24 months
Number of reports fo adverse events over 24 months
Time frame: 24 months
Description of reasons for switching to CAB LA + RPV LA
Time frame: 24 months
Changes in absolute values from baseline over 24 months in metabolic control parameters: glucose
Time frame: 24 months
Changes in absolute values from baseline over 24 months in metabolic control parameters: lipids
Time frame: 24 months
Changes in absolute values from baseline over 24 months in metabolic control parameters: weight
Time frame: 24 months
Changes in absolute values from baseline over 24 months in metabolic control parameters: waist circumference.
Time frame: 24 months
Changes in absolute values from baseline over 24 months in metabolic control parameters: BMI
Time frame: 24 months
Changes in pro-inflammatory biomarkers (D-Dimmer) from baseline over 24 months in a subgroup of participants
Time frame: 24 months
Changes in pro-inflammatory biomarkers (fibrinogen) from baseline over 24 months in a subgroup of participants
Time frame: 24 months
Changes in pro-inflammatory biomarkers (CRP) from baseline over 24 months in a subgroup of participants
Time frame: 24 months
Changes in pro-inflammatory biomarkers (IL-6) from baseline over 24 months in a subgroup of participants
Time frame: 24 months
Changes in creatinine values from baseline over 24 months
Time frame: 24 months
Changes in hepatic values (Albumine) from baseline over 24 months
Time frame: 24 months
Changes in hepatic values (Alanine transaminase (ALT), Aspartate transaminase (AST) and Alkaline phosphatase (ALP)) from baseline over 24 months
Time frame: 24 months
Changes in preference values from baseline over 24 months about ART
Time frame: 12 and 24 months
Changes in patient reported outcomes questionnaires from baseline over 24 months: WHOQOL-HIV-BREF
Time frame: 24 months
Changes in patient reported outcomes questionnaires from baseline over 24 months: HSSS
Time frame: 24 months
Changes in patient reported outcomes questionnaires from baseline over 24 months: PSQI
Time frame: 24 months
Incidence of adherence to scheduled interventions over 24 months
Time frame: 24 months
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 24 Jul 2024.
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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. This study is not recruiting at the moment.
CARMEN HIDALGO, PhD principal investigator
HU Virgen de las Nieves
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Human Immunodeficiency Virus, run by University Hospital Virgen de las Nieves at 15 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: under way, not looking for participants, as of the sponsor's last update on 24 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Spain. 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?
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?
Number of participants switching treatment to CAB LA + RPV LA regimen dosed every 2-months with plasma HIV-1 RNA ≥50 at month 12 (time frame: 12 months). 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 24 Jul 2024.