Outcomes of the PLHIV With Suboptimal Viral Suppression to Injectable Long-acting Antiretrovirals
Recruiting · NCT06507059 · Interventional (participants receive a specific treatment) · Lead sponsor: Chang Gung Memorial Hospital
View the official record on ClinicalTrials.gov →Interventions studied
Antiretroviral Combinationscabotegravir/rilpivirine (600mg/ 900mg)
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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.
Where it is running
4 locations listed.
- Chang Gung Memorial Hospital, Keelung - Keelung, Taiwan
- Chang Gung Memorial Hospital, Taipei - Taipei, Taiwan
- Taoyuan General Hospital, Ministry of Health and Welfare - Taoyuan, Taiwan
- Chang Gung Memorial Hospital, Linkou - Taoyuan, Taiwan