A Real-life Study of the Use of Cabotegravir Plus Rilpivirine Long-acting in ART-experienced Pre-treated People With HIV (CABO-CHANCE)

University Hospital Virgen de las Nieves

Status: Active, not recruiting

Conditions: Human Immunodeficiency Virus

Treatments: Drug: Cabotegravir Injectable Product; Drug: Rilpivirine Injectable Product

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06518408

FIB-CAB-2023-02

Details and patient eligibility

About

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.

Enrollment: 287 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

287 participants in 1 patient group

study group

Description:

Patients enrolled who switch to receive Cabotegravir long acting plus Rilpivirine long acting intramuscular injection every 2 months

Treatment:

Drug: Rilpivirine Injectable Product

Drug: Cabotegravir Injectable Product