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

NCT06518408 | Active Not Recruiting FDA Drug

• 1 other identifier: FIB-CAB-2023-02
• Study Type: observational
• Target: 287
• Locations: 1 country
• Sites: 15

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

Keywords

HIV; Long-Acting; Cabotegravir; Rilpivirine

Outcome Measures

Primary Outcomes (1)

• 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

  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

  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

  12 and 24 months

• Number of episodes of plasma HIV-1 RNA ≥50 copies/mL

  24 months

• Number of participants experiencing confirmed virologic failure at months 12 and 24.

  12 and 24 months

• Change from baseline in the mean lymphocyte subpopulations

  12 and 24 months

Study Arms (1)

study group

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

Drug: Cabotegravir Injectable Product; Drug: Rilpivirine Injectable Product

Interventions

Cabotegravir Injectable Product DRUG

long-acting regimen dosed every 2-months

Also known as: VOCABRIA (cabotegravir)

study group

Rilpivirine Injectable Product DRUG

long-acting regimen dosed every 2-months

Also known as: REKAMBYS (rilpivirine)

study group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Virgen de las Nieves: lead
• ViiV Healthcare: collaborator

Study Sites (15)

Hospital Universitario Virgen de Las Nieves

Granada, Andalusia, 18008, Spain

Location

Hospital San Pedro

Logroño, La Rioja, 26006, Spain

Location

Hospital Reina Sofía

Murcia, Murcia, 30003, Spain

Location

Hospital Universitario Puerto Real, INIBICA,

Cadiz, Spain

Location

Jerez de la Frontera University Hospital

Cadiz, Spain

Location

Reina Sofía University Hospital

Córdoba, Spain

Location

Hospital Campus de la Salud

Granada, 18014, Spain

Location

Hospital Comarcal Santa Ana de Motril

Granada, Spain

Location

Complejo Hospitalario de Jaén,

Jaén, Spain

Location

Hu La Princesa

Madrid, Spain

Location

Ramon Y Cajal

Madrid, Spain

Location

Hospital General Universitario Santa Lucía

Murcia, Spain

Location

Hospital de Son Llàtzer

Palma de Mallorca, Spain

Location

Hospital Universitario de Canarias

Santa Cruz de Tenerife, Spain

Location

Hospital Clínico Universitario Lozano Blesa

Zaragoza, Spain

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

cabotegravir; Rilpivirine

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• CARMEN HIDALGO, PhD

  HU Virgen de las Nieves

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 9, 2024
• First Posted: July 24, 2024
• Study Start: June 1, 2023
• Primary Completion: April 30, 2026
• Study Completion (Estimated): September 30, 2027
• Last Updated: July 24, 2024

Record last verified: 2024-07

Locations

ES (15)