Clinical trial NCT06518408: A Real-life Study of the Use of Cabotegravir Plus Rilpivirine Long-acting in ART-experienced Pre-treated People With HIV
Official title: A Real-life Study of the Use of Cabotegravir Plus Rilpivirine Long-acting in ART-experienced Pre-treated People With HIV
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Human Immunodeficiency Virus
Keywords: HIV
Long-Acting
Cabotegravir
Rilpivirine
Lead sponsor: University Hospital Virgen de las Nieves
Sponsor class: OTHER
Collaborators: name: ViiV Healthcare
First posted: 2024-07-24
Enrollment: 287
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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

Brief 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. 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.


Eligibility criteria: 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

Primary outcomes:
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
timeFrame: 12 months
Secondary outcomes:
measure: Number of participants switching treatment to CAB LA + RPV LA regimen dosed every 2-months with plasma HIV-1 RNA ≥50 at month 24
timeFrame: 24 months
measure: 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
timeFrame: 12 and 24 months
measure: Number of episodes of plasma HIV-1 RNA ≥50 copies/mL
timeFrame: 24 months
measure: Number of participants experiencing confirmed virologic failure at months 12 and 24.
timeFrame: 12 and 24 months
measure: Change from baseline in the mean lymphocyte subpopulations
timeFrame: 12 and 24 months
measure: Incidence and severity of adverse events
timeFrame: 24 months
measure: Description of reasons for discontinuation from CAB LA + RPV LA over 24 months
timeFrame: 24 months
measure: Number of reports fo adverse events over 24 months
timeFrame: 24 months
measure: Description of reasons for switching to CAB LA + RPV LA
timeFrame: 24 months
measure: Changes in absolute values from baseline over 24 months in metabolic control parameters: glucose
timeFrame: 24 months
measure: Changes in absolute values from baseline over 24 months in metabolic control parameters: lipids
timeFrame: 24 months
measure: Changes in absolute values from baseline over 24 months in metabolic control parameters: weight
timeFrame: 24 months
measure: Changes in absolute values from baseline over 24 months in metabolic control parameters: waist circumference.
timeFrame: 24 months
measure: Changes in absolute values from baseline over 24 months in metabolic control parameters: BMI
timeFrame: 24 months
measure: Changes in pro-inflammatory biomarkers (D-Dimmer) from baseline over 24 months in a subgroup of participants
timeFrame: 24 months
measure: Changes in pro-inflammatory biomarkers (fibrinogen) from baseline over 24 months in a subgroup of participants
timeFrame: 24 months
measure: Changes in pro-inflammatory biomarkers (CRP) from baseline over 24 months in a subgroup of participants
timeFrame: 24 months
measure: Changes in pro-inflammatory biomarkers (IL-6) from baseline over 24 months in a subgroup of participants
timeFrame: 24 months
measure: Changes in creatinine values from baseline over 24 months
timeFrame: 24 months
measure: Changes in hepatic values (Albumine) from baseline over 24 months
timeFrame: 24 months
measure: Changes in hepatic values (Alanine transaminase (ALT), Aspartate transaminase (AST) and Alkaline phosphatase (ALP)) from baseline over 24 months
timeFrame: 24 months
measure: Changes in preference values from baseline over 24 months about ART
timeFrame: 12 and 24 months
measure: Changes in patient reported outcomes questionnaires from baseline over 24 months: WHOQOL-HIV-BREF
timeFrame: 24 months
measure: Changes in patient reported outcomes questionnaires from baseline over 24 months: HSSS
timeFrame: 24 months
measure: Changes in patient reported outcomes questionnaires from baseline over 24 months: PSQI
timeFrame: 24 months
measure: Incidence of adherence to scheduled interventions over 24 months
timeFrame: 24 months
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Hospital Universitario Virgen de Las Nieves
state: Andalucía
city: Logroño
country: Spain
facility: Hospital San Pedro
state: La Rioja
city: Murcia
country: Spain
facility: Hospital Reina Sofía
state: Región De Murcia
city: Cadiz
country: Spain
facility: Hospital Universitario Puerto Real, INIBICA,
city: Cadiz
country: Spain
facility: Jerez de la Frontera University Hospital
city: Córdoba
country: Spain
facility: Reina Sofía University Hospital
city: Granada
country: Spain
facility: Hospital Campus de la Salud
city: Granada
country: Spain
facility: Hospital Comarcal Santa Ana de Motril
city: Jaén
country: Spain
facility: Complejo Hospitalario de Jaén,
city: Madrid
country: Spain
facility: Hu La Princesa
city: Madrid
country: Spain
facility: Ramon Y Cajal
city: Murcia
country: Spain
facility: Hospital General Universitario Santa Lucía
city: Palma De Mallorca
country: Spain
facility: Hospital de Son Llàtzer
city: Tenerife
country: Spain
facility: Hospital Universitario de Canarias
city: Zaragoza
country: Spain
facility: Hospital Clínico Universitario Lozano Blesa
Study officials:
affiliation: HU Virgen de las Nieves
name: CARMEN HIDALGO, PhD
role: PRINCIPAL_INVESTIGATOR
References: