Outcomes of the PLHIV With Suboptimal Viral Suppression to Injectable Long-acting Antiretrovirals
Launched by CHANG GUNG MEMORIAL HOSPITAL · Jul 11, 2024
Trial Information
Current as of July 09, 2025
Recruiting
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.
About Chang Gung Memorial Hospital
Chang Gung Memorial Hospital, one of the largest healthcare organizations in Taiwan, is renowned for its commitment to advancing medical research and improving patient care. As a clinical trial sponsor, the hospital leverages its extensive clinical expertise and state-of-the-art facilities to conduct innovative research across various medical disciplines. With a focus on collaboration and ethical practices, Chang Gung Memorial Hospital aims to contribute to the global body of medical knowledge through rigorous clinical trials that enhance treatment options and improve health outcomes for patients.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Taoyuan, , Taiwan
Keelung, , Taiwan
Taipei, , Taiwan
Taoyuan, , Taiwan
Patients applied
Trial Officials
Nan-Yu Chen, MD, PhD
Principal Investigator
Chang Gung Memorial Hospital
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported