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

NCT ID: NCT06518408

Last Updated: 2024-07-24

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 287 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2027-09-30

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.

Conditions

Human Immunodeficiency Virus

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

study group

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

Cabotegravir Injectable Product

Intervention Type: DRUG

long-acting regimen dosed every 2-months

Rilpivirine Injectable Product

Intervention Type: DRUG

long-acting regimen dosed every 2-months

Interventions

Cabotegravir Injectable Product

long-acting regimen dosed every 2-months

Intervention Type: DRUG

Rilpivirine Injectable Product

long-acting regimen dosed every 2-months

Intervention Type: DRUG

Other Intervention Names

VOCABRIA (cabotegravir); REKAMBYS (rilpivirine)

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ViiV Healthcare

INDUSTRY

Sponsor Role: collaborator

University Hospital Virgen de las Nieves

OTHER

Sponsor Role: lead

Responsible Party

Carmen Hidalgo Tenorio

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

CARMEN HIDALGO, PhD

Role: PRINCIPAL_INVESTIGATOR

HU Virgen de las Nieves

Locations

Hospital Universitario Virgen de Las Nieves

Granada, Andalusia, Spain

Hospital San Pedro

Logroño, La Rioja, Spain

Hospital Reina Sofía

Murcia, Murcia, Spain

Hospital Universitario Puerto Real, INIBICA,

Cadiz, , Spain

Jerez de la Frontera University Hospital

Cadiz, , Spain

Reina Sofía University Hospital

Córdoba, , Spain

Hospital Campus de la Salud

Granada, , Spain

Hospital Comarcal Santa Ana de Motril

Granada, , Spain

Complejo Hospitalario de Jaén,

Jaén, , Spain

Hu La Princesa

Madrid, , Spain

Ramon Y Cajal

Madrid, , Spain

Hospital General Universitario Santa Lucía

Murcia, , Spain

Hospital de Son Llàtzer

Palma de Mallorca, , Spain

Hospital Universitario de Canarias

Santa Cruz de Tenerife, , Spain

Hospital Clínico Universitario Lozano Blesa

Zaragoza, , Spain

Countries

Spain

Other Identifiers

FIB-CAB-2023-02

Identifier Type: -

Identifier Source: org_study_id