A Phase 3 interventional study of cabotegravir/rilpivirine (600mg/ 900mg) and Antiretroviral Combinations in HIV-1-infection and Non-Adherence, Medication, sponsored by Chang Gung Memorial Hospital. Recruiting at 4 sites in Taiwan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-23.
Sponsored by Chang Gung Memorial Hospital · Phase 3, Interventional, and Treatment
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.
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 with suboptimal viral suppression despite antiretroviral treatment (ART), with the latest HIV-1 viral load ≥ 200 copies/mL. Participants' eligibility will be assessed through a review of their medical records, and individuals with established resistance to cabotegravir or rilpivirine will be excluded. Enrolled participants will then be randomized 1:1 to either "Delayed Switch to LA Treatment Group" or "Immediate LA Treatment Group" on enrollment. The "Delayed Switch to LA Treatment Group" will also switch to LA on week 24. The proportion of participants with HIV-1 RNA \<200 copies/mL at week 24 in the two study groups will be compared. Psychologic assessments including self-stigma and depression assessment will also be performed on day1, at week 24 and week 52.
Chang Gung Memorial Hospital is the lead sponsor of 1,064 studies on the registry; 235 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Immediate switch to long-acting injectable antiretrovirals on enrollment
Drug: cabotegravir/rilpivirine (600mg/ 900mg)
Keep on standard all-oral antiretrovirals on enrollment for 24 weeks, then switch to long-acting injectable antiretrovirals
Drug: Antiretroviral Combinations
Immediate switch from oral antiretroviral to long-acting injectables
Also known as: Cabenuva
Standard all-oral antiretroviral combinations
HIV-1 RNA <200 copies/mL
Percentage of study participants with plasma HIV-1 RNA \<200 copies/mL at week 24
Time frame: Week 24
HIV-1 RNA <50 copies/mL
Percentage of study participants with plasma HIV-1 RNA \<50 copies/mL at week 24, 52
Time frame: 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
Time frame: Week 52
Change of plasma HIV-1 viral load
Change of plasma HIV-1 RNA at week 24, 52
Time frame: Week 24, week 52
Change of CD4 count
Change of CD4 count at week 24, 52
Time frame: Week 24, week 52
Occurrence of HIV and non-HIV related conditions
Percentage of study participants with HIV and non-HIV related conditions occurrence
Time frame: Week 24, week 52
Lost F/U rate
Lost follow-up rate at every target visit
Time frame: up to week 96
Usage of outreach drug delivery service
Percentage of study participants who use the outreach drug delivery service
Time frame: up to week 52
Resistant variant emergence
Resistant variant emergence detection if HIV-1 viral load ≥200 copies/mL
Time frame: Week 24, week 52
Adverse events
Incidence and severity of adverse events (AEs)
Time frame: Week 24, week 52
Discontinuation due to AEs
Discontinuation due to AEs at week 24, 52
Time frame: Week 24, week 52
Change of depression score
Change of depression score at week 24, 52
Time frame: Week 24, week 52
Change of self-stigma score
Change of self-stigma score at week 24, 52
Time frame: Week 24, week 52
Change of metabolic parameters
Change of metabolic parameters (body weight, BMI) at week 24, 52
Time frame: Week 24, week 52
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
Time frame: Week 52
Change of acceptability score
Acceptability assessment for long-acting injectable antiretrovirals
Time frame: 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)
Time frame: up to week 52
HIV-1 RNA <50 copies/mL
Percentage of study participants with plasma HIV-1 RNA \<50 copies/mL
Time frame: Week 72, week 96
Plan to share: No
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Chang Gung Memorial Hospital