Antiviral Long Acting Drugs Landing in People Living With HIV (NCT06468995) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Antiviral Long Acting Drugs Landing in People Living With HIV
Italy120 participantsStarted 2024-12-02
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 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.
Exclusion Criteria:
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
* Any evidence of a current Center for Disease Control and Prevention (CDC) Stage 3 disease…