Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:38 PM
Ignite Modification Date:
2025-12-24 @ 2:38 PM
NCT ID:
NCT06507059
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06507059
Study Brief:
Protocol Section:
NCT06507059