Improving viral suppression in HIV patients with poor medication adherence using long-acting treatments
A Phase 3 Study Comparing Clinical Outcomes in People Living With HIV (PLHIV) With Suboptimal Adherence Treated With Injectable Long-acting Antiretrovirals Versus Oral Antiretrovirals
PHASE3 · Chang Gung Memorial Hospital · NCT06507059
This study is testing if switching to long-acting HIV medications can help people who have trouble sticking to their treatment better control the virus.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Chang Gung Memorial Hospital (other) |
| Locations | 4 sites (Keelung and 3 other locations) |
| Trial ID | NCT06507059 on ClinicalTrials.gov |
What this trial studies
This study investigates whether long-acting antiretrovirals can enhance viral suppression in individuals living with HIV who have struggled with medication adherence. It is an open-label, multi-center, randomized trial involving 40 adult participants diagnosed with HIV for at least 12 months and exhibiting suboptimal viral suppression. Participants will be randomly assigned to either switch to long-acting treatment immediately or after 24 weeks, with their viral loads monitored over the course of the study. Psychological assessments related to self-stigma and depression will also be conducted at various points during the trial.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older living with HIV for at least 12 months and experiencing suboptimal viral suppression despite antiretroviral treatment.
Not a fit: Patients with established resistance to cabotegravir or rilpivirine will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve viral suppression rates in patients with HIV who have difficulty adhering to traditional oral medication regimens.
How similar studies have performed: Other studies have shown promise in using long-acting antiretrovirals for improving adherence and viral suppression, indicating that this approach is not entirely novel but still holds significant potential.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Keelung and 3 other locations
- Chang Gung Memorial Hospital, Keelung — Keelung, Taiwan (RECRUITING)
- Chang Gung Memorial Hospital, Taipei — Taipei, Taiwan (RECRUITING)
- Taoyuan General Hospital, Ministry of Health and Welfare — Taoyuan, Taiwan (RECRUITING)
- Chang Gung Memorial Hospital, Linkou — Taoyuan, Taiwan (RECRUITING)
Study contacts
- Principal investigator: Nan-Yu Chen, MD, PhD — Chang Gung Memorial Hospital
- Study coordinator: Nan-Yu Chen, MD, PhD
- Email: nanyuchen@cgmh.org.tw
- Phone: +886 3 3281200
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: HIV-1-infection, Non-Adherence, Medication, HIV-1, non-adherence