Clinical trial NCT06507059: Outcomes of the PLHIV With Suboptimal Viral Suppression to Injectable Long-acting Antiretrovirals
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: HIV-1-infection
Non-Adherence, Medication
Keywords: HIV-1, non-adherence
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
Collaborators: name: Taoyuan General Hospital
First posted: 2024-07-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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.

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.

Primary outcomes:
measure: HIV-1 RNA <200 copies/mL
timeFrame: Week 24
Secondary outcomes:
measure: HIV-1 RNA <50 copies/mL
timeFrame: Week 24, week 52
measure: HIV-1 RNA <200 copies/mL
timeFrame: Week 52
measure: Change of plasma HIV-1 viral load
timeFrame: Week 24, week 52
measure: Change of CD4 count
timeFrame: Week 24, week 52
measure: Occurrence of HIV and non-HIV related conditions
timeFrame: Week 24, week 52
measure: Lost F/U rate
timeFrame: up to week 96
measure: Usage of outreach drug delivery service
timeFrame: up to week 52
measure: Resistant variant emergence
timeFrame: Week 24, week 52
measure: Adverse events
timeFrame: Week 24, week 52
measure: Discontinuation due to AEs
timeFrame: Week 24, week 52
measure: Change of depression score
timeFrame: Week 24, week 52
measure: Change of self-stigma score
timeFrame: Week 24, week 52
measure: Change of metabolic parameters
timeFrame: Week 24, week 52
Other outcomes:
measure: Achieved ART trough level assessment
timeFrame: Week 52
measure: Change of acceptability score
timeFrame: 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.
measure: Delayed injections
timeFrame: up to week 52
measure: HIV-1 RNA <50 copies/mL
timeFrame: Week 72, week 96
Locations:
city: Keelung
country: Taiwan
facility: Chang Gung Memorial Hospital, Keelung
city: Taipei
country: Taiwan
facility: Chang Gung Memorial Hospital, Taipei
city: Taoyuan
country: Taiwan
facility: Taoyuan General Hospital, Ministry of Health and Welfare
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital, Linkou
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Nan-Yu Chen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: