Outcomes of the PLHIV With Suboptimal Viral Suppression to Injectable Long-acting Antiretrovirals
NCT Number: NCT06507059
Acronym: SUPLA
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: HIV-1-infection|Non-Adherence, Medication
Interventions: DRUG: cabotegravir/rilpivirine (600mg/ 900mg)|DRUG: Antiretroviral Combinations
Sponsor: Chang Gung Memorial Hospital
Collaborators: Taoyuan General Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-19
Completion Date: 2026-12-31
Locations: Chang Gung Memorial Hospital, Keelung, Keelung, 204, Taiwan|Chang Gung Memorial Hospital, Taipei, Taipei, 105, Taiwan|Taoyuan General Hospital, Ministry of Health and Welfare, Taoyuan, 330, Taiwan|Chang Gung Memorial Hospital, Linkou, Taoyuan, 333, Taiwan

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.

Primary Outcome Measures: HIV-1 RNA <200 copies/mL, Percentage of study participants with plasma HIV-1 RNA \<200 copies/mL at week 24, Week 24
Secondary Outcome Measures: HIV-1 RNA <50 copies/mL, Percentage of study participants with plasma HIV-1 RNA \<50 copies/mL at week 24, 52, Week 24, week 52|HIV-1 RNA <200 copies/mL, Percentage of study participants with plasma HIV-1 RNA \<200 copies/mL at week 52, Week 52|Change of plasma HIV-1 viral load, Change of plasma HIV-1 RNA at week 24, 52, Week 24, week 52|Change of CD4 count, Change of CD4 count at week 24, 52, Week 24, week 52|Occurrence of HIV and non-HIV related conditions, Percentage of study participants with HIV and non-HIV related conditions occurrence, Week 24, week 52|Lost F/U rate, Lost follow-up rate at every target visit, up to week 96|Usage of outreach drug delivery service, Percentage of study participants who use the outreach drug delivery service, up to week 52|Resistant variant emergence, Resistant variant emergence detection if HIV-1 viral load ≥200 copies/mL, Week 24, week 52|Adverse events, Incidence and severity of adverse events (AEs), Week 24, week 52|Discontinuation due to AEs, Discontinuation due to AEs at week 24, 52, Week 24, week 52|Change of depression score, Change of depression score at week 24, 52, Week 24, week 52|Change of self-stigma score, Change of self-stigma score at week 24, 52, Week 24, week 52|Change of metabolic parameters, Change of metabolic parameters (body weight, BMI) at week 24, 52, Week 24, week 52
Other Outcome Measures: Achieved ART trough level assessment, Use liquid chromatography- mass spectrometry to determine rilpivirine and cabotegravir concentrations in stored remaining plasma specimen collected at each visit, Week 52|Change of acceptability score, Acceptability assessment for long-acting injectable antiretrovirals, Day1 (post-injection), week 24, 52 for the immediate LA treatment group; week 24 (post-injection), and week 52 for the delayed switch to LA group.|Delayed injections, Percentage of delayed injections (\>7 days after the target visit), up to week 52|HIV-1 RNA <50 copies/mL, Percentage of study participants with plasma HIV-1 RNA \<50 copies/mL, Week 72, week 96