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

Launched by CHANG GUNG MEMORIAL HOSPITAL · Jul 11, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at whether long-acting injectable treatments can help people living with HIV who have had trouble sticking to their medication routines. Researchers want to see if these injections can lead to better viral suppression, meaning lower levels of the virus in the blood, compared to the usual oral medications. The trial is currently recruiting participants aged 18 and older who have been diagnosed with HIV for at least a year and have a recent viral load of 200 copies/mL or more.

To participate, individuals must be willing to receive injections in their buttocks and stay in touch with the research team throughout the study. They should also be able to transition back to oral medications after the study if needed. However, some people may not be eligible, such as those who have recently changed their oral medication or who have specific health issues. Participants can expect to receive close monitoring and support during the trial, helping researchers understand how these long-acting treatments might improve health outcomes for those struggling with medication adherence.

Gender

ALL

Eligibility criteria

• 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.