Status:
RECRUITING
Outcomes of the PLHIV With Suboptimal Viral Suppression to Injectable Long-acting Antiretrovirals
Lead Sponsor:
Chang Gung Memorial Hospital
Collaborating Sponsors:
Taoyuan General Hospital
Conditions:
HIV-1-infection
Non-Adherence, Medication
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 an...
Detailed Description
This is an open-label, multi-center, randomized, active-controlled, superiority trial on 40 adult subjects who had been diagnosed to have HIV infection for at least 12 months before enrollment but wit...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 19 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06507059
Start Date
July 19 2024
End Date
December 31 2026
Last Update
August 23 2024
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Chang Gung Memorial Hospital, Keelung
Keelung, Taiwan, 204
2
Chang Gung Memorial Hospital, Taipei
Taipei, Taiwan, 105
3
Taoyuan General Hospital, Ministry of Health and Welfare
Taoyuan District, Taiwan, 330
4
Chang Gung Memorial Hospital, Linkou
Taoyuan District, Taiwan, 333