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Completed NCT06468995

Antiviral Long Acting Drugs Landing in People Living With HIV

Conditions: HIV, Antiviral Agents

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Phase: NA
Enrollment: 120
Sponsor: IRCCS San Raffaele

Location: IRCCS San Raffaele Scientific Institute Milan

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.

Eligibility Criteria

Inclusion Criteria: * 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 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 * Any evidence of a current Center for Disease Control and Prevention (CDC) Stage 3 disease, except cutaneous Kaposi's sarcoma not requiring systemic therapy, and CD4+ counts \

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06468995). StuddyBuddy aggregates publicly available trial information.