NCT06507059 Outcomes of the PLHIV With Suboptimal Viral Suppression to Injectable Long-acting Antiretrovirals
| NCT ID | NCT06507059 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Chang Gung Memorial Hospital |
| Condition | HIV-1-infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-07-19 |
| Primary Completion | 2025-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 40 participants in total. It began in 2024-07-19 with a primary completion date of 2025-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 antiretrovirals.
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.
Contact & Investigator
Nan-Yu Chen, MD, PhD
PRINCIPAL INVESTIGATOR
Chang Gung Memorial Hospital
Frequently Asked Questions
Who can join the NCT06507059 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying HIV-1-infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06507059 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 40 participants.
Is NCT06507059 currently recruiting?
Yes, NCT06507059 is actively recruiting participants. Contact the research team at nanyuchen@cgmh.org.tw for enrollment information.
Where is the NCT06507059 trial being conducted?
This trial is being conducted at Keelung, Taiwan, Taipei, Taiwan, Taoyuan, Taiwan, Taoyuan, Taiwan.
Who is sponsoring the NCT06507059 clinical trial?
NCT06507059 is sponsored by Chang Gung Memorial Hospital. The principal investigator is Nan-Yu Chen, MD, PhD at Chang Gung Memorial Hospital. The trial plans to enroll 40 participants.
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