Antiviral Long Acting Drugs Landing in People Living With HIV

NCT06468995 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-03-10

No results posted yet for this study

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

  • HIV
  • Antiviral Agents

Interventions

OTHER

Surveys completion

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).

DRUG

Home administration of CAB+RPV

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

DRUG

Hospital administration of CAB+RPV

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

Sponsors & Collaborators

Principal Investigators

  • Silvia Nozza, MD · Vita-Salute San Raffaele University

  • Antonella Castagna, Prof · Vita-Salute San Raffaele University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-12-02
Primary Completion
2026-07-01
Completion
2026-07-01

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06468995 on ClinicalTrials.gov