Antiviral Long Acting Drugs Landing in People Living With HIV

NCT06468995 | Active Not Recruiting

• 1 other identifier: CET 166-2024
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This is a monocentric, prospective, double-arm, randomized, open-label, implementation-effectiveness hybrid type III study aimed at comparing hospital-based and home-based administration of CAB LA + RPV LA treatment for HIV-1-infected patients. Study participants receiving IM CAB + RPV will complete various questionnaires and scales, including FIM, AIM, IAM, EQ-5D-5L, HAT-QoL, and HIVTSQ, throughout the study. HCPs will also complete FIM, AIM, IAM, and a Likert scale.

Conditions

Antiviral Agents; HIV

Keywords

Rilpivirine; Cabotegravir; HIV; Long acting; Antiretroviral; PLWH

Outcome Measures

Primary Outcomes (4)

• Feasibility of Implementation Measure (FIM) scale

  Proportion of participants receiving injections with an average composite score greater than or equal to 4 across the questions of Feasibility of Implementation Measure (FIM) and average composite score.

  Months 1 and 7 and 11

• Acceptability of Intervention Measure (AIM) scale

  Proportion of participants receiving injections with an average composite score greater than or equal to 4 across the questions of Acceptability of Intervention Measure (AIM) and average composite score.

  Months 1 and 7 and 11

• Intervention Appropriateness Measure (IAM) scale

  Proportion of participants receiving injections with an average composite score greater than or equal to 4 across the questions of Intervention Appropriateness Measure (IAM) and average composite score.

  Months 1 and 7 and 11

• Qualitative insights

  Qualitative insights regarding feasibility, acceptability, and appropriateness of CAB+RPV IM q2M.

  Months 1 and 7 and 11

Secondary Outcomes (10)

• Proportion of patients willing to enroll in the study

  Months 7 and 11

• Proportion of patients voluntary asking to stop CAB+RPV LA administration

  Months 7 and 11

• Proportion of CAB+RPV LA injections occurring within the target window

  Months 7 and 11

• Average score of satisfaction on a Likert scale

  Months 7 and 11

• Proportion of PWH with HIV-RNA >50 copies/mL

  Months 7 and 11

Study Arms (2)

Hospital arm

ACTIVE COMPARATOR

CAB 600mg +RPV 900mg q2M IM administration and follow-up in hospital

Other: Surveys completion; Drug: Hospital administration of CAB+RPV

Home arm

EXPERIMENTAL

CAB 600mg +RPV 900mg q2M IM administration and follow-up at home

Other: Surveys completion; Drug: Home administration of CAB+RPV

Interventions

Surveys completion OTHER

Completion of surveys: the Feasibility of Implementation Measure (FIM), the Acceptability of Intervention Measure (AIM), the Intervention Appropriateness Measure (IAM), a Likert scale, the EQ-5D-5L questionnaire, the HIV/AIDS-Targeted Quality of Life (HAT-QoL) questionnaire and the HIV Treatment Satisfaction Questionnaire (HIVTSQ).

Home arm; Hospital arm

Home administration of CAB+RPV DRUG

Drug treatment and follow-up at home (home arm).

Home arm

Hospital administration of CAB+RPV DRUG

Drug treatment and follow-up in hospital (hospital arm)

Hospital arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• People living with HIV-1 infection that could, according to clinical practice, switch current ART to IM CAB + RPV;
• Aged 18 years or older at the time of signing the informed consent.
• People willing to switch to long-acting therapy
• on a stable (≥6 months) antiretroviral regimen and virologically suppressed (HIV-1 RNA \<50 copies/ml):
• Documented evidence of plasma HIV-1 RNA measurements \<50 c/mL in the 6 months prior to Screening.
• Plasma HIV-1 RNA \<50 c/mL at Screening.
• Ability to understand informed consent form and other relevant regulatory documents.

You may not qualify if:

• An individual who meets any of the following criteria will be excluded from participation in this study:
• Within 6 months prior to Screening, any plasma HIV-1 RNA measurement \>=50 c/mL or within the 6 to 12-month window prior to Screening, any plasma HIV-1 RNA measurement \>200 c/mL, or 2 or more plasma HIV-1 RNA measurements \>=50 c/mL.
• 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
• Unwillingness or any condition that might prevent the completion of all surveys over study follow-up.
• Any contraindication for CAB LA, RPV LA, oral Cabotegravir or Rilpivirine (see EU SmPC):
• Women who are pregnant, breastfeeding or plan to become pregnant or breastfeed during the study
• Participants with moderate to severe hepatic impairment
• Any pre-existing physical or mental condition (including substance use disorder) which, in the opinion of the Investigator, may interfere with the participant's ability to comply with the dosing schedule and/or protocol evaluations or which may compromise the safety of the participant
• 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.
• Asymptomatic individuals with chronic hepatitis C virus (HCV) infection will not be excluded, however Clinicians must carefully assess if therapy specific for HCV infection is required; participants who require or qualify for immediate HCV treatment are excluded
• Unstable liver disease (as defined by any of the following: presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice or cirrhosis, or decompensated cirrhosis (eg. ascites, encephalopathy, or variceal bleeding)), known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones or otherwise stable chronic liver disease per investigator assessment)
• History of liver cirrhosis with or without hepatitis viral co-infection.

Sponsors & Collaborators

• IRCCS San Raffaele: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

IRCCS San Raffaele Scientific Institute

Milan, 20127, Italy

Location

Study Officials

• Silvia Nozza, MD

  Vita-Salute San Raffaele University

  PRINCIPAL INVESTIGATOR

• Antonella Castagna, Prof

  Vita-Salute San Raffaele University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: June 12, 2024
• First Posted: June 21, 2024
• Study Start: December 2, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)