RecruitingPhase 3NCT06507059

Outcomes of the PLHIV With Suboptimal Viral Suppression to Injectable Long-acting Antiretrovirals

A Phase 3 Study Comparing Clinical Outcomes in People Living With HIV (PLHIV) With Suboptimal Adherence Treated With Injectable Long-acting Antiretrovirals Versus Oral Antiretrovirals

Sponsor

Chang Gung Memorial Hospital

Enrollment

40 participants

Start Date

Jul 19, 2024

Study Type

INTERVENTIONAL

Conditions

HIV-1-infection Non-Adherence, Medication

Summary

This study aims to determine whether people living with HIV (PLHIV) with suboptimal medical adherence can achieve better viral suppression with long-acting antiretrovirals (LA) compared to all-oral antiretrovirals.

Eligibility

Min Age: 18 Years

Inclusion Criteria7

Willing to sign the written informed consent form for male and female participants aged 18 and above.
At the time of enrollment, diagnosed with HIV infection for a minimum of 12 months.
Under oral antiretroviral treatment (ART), which can be irregular or interrupted, with the most recent viral load ≥ 200 copies/mL.
Body weight ≥ 35Kg.
Willing to maintain contact with the research team throughout the study (provide accurate and reachable phone numbers, social accounts like Line, or reliable contact information of family or friends).
Willing to receive gluteal (buttocks) drug injections.
Willing to transition back to oral medication or follow the recommended treatment prescription according to the then-current national treatment guidelines after discontinuation of long-acting injectable drugs.

Exclusion Criteria6

For those currently undergoing oral antiretroviral therapy, who have started or restarted oral ART for less than six consecutive months before screening.
Previously undergone HIV drug resistance testing and known to have resistance mutations to either cabotegravir or rilpivirine.
Unable to commit to maintaining contact with the research team throughout the study.
Individuals who cannot receive treatment for hepatitis B during the period of transitioning to long-acting injections, if they are hepatitis B carriers.
Individuals with buttock fillers.
Women who are planning to become pregnant, pregnant, or currently breastfeeding.