HIV-1-infectionPhase 3SUPLANCT06507059
Outcomes of the PLHIV With Suboptimal Viral Suppression to Injectable Long-acting Antiretrovirals
A Phase 3 study testing cabotegravir/rilpivirine (600mg/ 900mg) and Antiretroviral Combinations in people with HIV-1-infection and Non-Adherence, Medication, run by Chang Gung Memorial Hospital at 4 sites in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV-1-infection, Non-Adherence, Medication
- What is being tested?
- cabotegravir/rilpivirine (600mg/ 900mg) and Antiretroviral Combinations
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 4 sitesTaiwan
- Study dates
- 19 Jul 2024to 28 Feb 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
Taiwan4 sites
Chang Gung Memorial Hospital, Keelung
Keelung, 204
Chang Gung Memorial Hospital, Taipei
Taipei, 105
Taoyuan General Hospital, Ministry of Health and Welfare
Taoyuan, 330
Chang Gung Memorial Hospital, Linkou
Taoyuan, 333
About this study
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
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.
Read the 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.
- Conditions
- HIV-1-infection, Non-Adherence, Medication
- Being tested
- cabotegravir/rilpivirine (600mg/ 900mg), Antiretroviral Combinations
- Keywords
- HIV-1, non-adherence
- Medical subject headings
- Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cabotegravir/rilpivirine (600mg/ 900mg)Drug
Also called Cabenuva
Immediate switch from oral antiretroviral to long-acting injectables
Antiretroviral CombinationsDrug
Standard all-oral antiretroviral combinations
| Study group | Role | What they receive |
|---|---|---|
| Immediate Long-Acting Injectable Treatment Group | Experimental | Immediate switch to long-acting injectable antiretrovirals on enrollment Receives: Drug: cabotegravir/rilpivirine (600mg/ 900mg) |
| Delayed Long-Acting Injectable Treatment Group | Active comparator | Keep on standard all-oral antiretrovirals on enrollment for 24 weeks, then switch to long-acting injectable antiretrovirals Receives: Drug: Antiretroviral Combinations |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV-1 RNA <200 copies/mL
Percentage of study participants with plasma HIV-1 RNA <200 copies/mL at week 24
Measured: Week 24
Secondary outcomes (13)
HIV-1 RNA <50 copies/mL
Percentage of study participants with plasma HIV-1 RNA <50 copies/mL at week 24, 52
Measured: 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
Measured: Week 52
Change of plasma HIV-1 viral load
Change of plasma HIV-1 RNA at week 24, 52
Measured: Week 24, week 52
Change of CD4 count
Change of CD4 count at week 24, 52
Measured: Week 24, week 52
Occurrence of HIV and non-HIV related conditions
Percentage of study participants with HIV and non-HIV related conditions occurrence
Measured: Week 24, week 52
Lost F/U rate
Lost follow-up rate at every target visit
Measured: up to week 96
Usage of outreach drug delivery service
Percentage of study participants who use the outreach drug delivery service
Measured: up to week 52
Resistant variant emergence
Resistant variant emergence detection if HIV-1 viral load ≥200 copies/mL
Measured: Week 24, week 52
Adverse events
Incidence and severity of adverse events (AEs)
Measured: Week 24, week 52
Discontinuation due to AEs
Discontinuation due to AEs at week 24, 52
Measured: Week 24, week 52
Change of depression score
Change of depression score at week 24, 52
Measured: Week 24, week 52
Change of self-stigma score
Change of self-stigma score at week 24, 52
Measured: Week 24, week 52
Change of metabolic parameters
Change of metabolic parameters (body weight, BMI) at week 24, 52
Measured: Week 24, week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2024
- Study start19 Jul 2024
- Primary completion6 Aug 2025
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-1-infectionStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Taoyuan General Hospital
- Responsible party
- Sponsor
- Investigators
- Nan-Yu Chen, MD, PhD, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06507059
- Sponsor's protocol ID
- 202301496A3
- Other IDs
- MOHW113-CDC-C-114-000106
- Acronym
- SUPLA
- Status last verified
- Mar 2026
- First submitted
- 7 Jul 2024
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06507059
- Acronym / sponsor ID
- SUPLA / 202301496A3
- Conditions
- HIV-1-infection, Non-Adherence, Medication
- Keywords
- HIV-1, non-adherence
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Collaborators
- Taoyuan General Hospital
- Study start
- 19 Jul 2024 (actual)
- Primary completion
- 6 Aug 2025 (actual)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 18 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate Long-Acting Injectable Treatment Group | Experimental | Drug: cabotegravir/rilpivirine (600mg/ 900mg)Immediate switch to long-acting injectable antiretrovirals on enrollment |
| Delayed Long-Acting Injectable Treatment Group | Active comparator | Drug: Antiretroviral CombinationsKeep on standard all-oral antiretrovirals on enrollment for 24 weeks, then switch to long-acting injectable antiretrovirals |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cabotegravir/rilpivirine (600mg/ 900mg)Also: CabenuvaImmediate switch from oral antiretroviral to long-acting injectables | Drug | Immediate Long-Acting Injectable Treatment Group |
| Antiretroviral CombinationsStandard all-oral antiretroviral combinations | Drug | Delayed Long-Acting Injectable Treatment Group |
Primary outcome
HIV-1 RNA <200 copies/mL
Time frame: Week 24
Percentage of study participants with plasma HIV-1 RNA <200 copies/mL at week 24
13 secondary outcomes
HIV-1 RNA <50 copies/mL
Time frame: Week 24, week 52
HIV-1 RNA <200 copies/mL
Time frame: Week 52
Change of plasma HIV-1 viral load
Time frame: Week 24, week 52
Change of CD4 count
Time frame: Week 24, week 52
Occurrence of HIV and non-HIV related conditions
Time frame: Week 24, week 52
Lost F/U rate
Time frame: up to week 96
Usage of outreach drug delivery service
Time frame: up to week 52
Resistant variant emergence
Time frame: Week 24, week 52
Adverse events
Time frame: Week 24, week 52
Discontinuation due to AEs
Time frame: Week 24, week 52
Change of depression score
Time frame: Week 24, week 52
Change of self-stigma score
Time frame: Week 24, week 52
Change of metabolic parameters
Time frame: Week 24, week 52
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nan-Yu Chen, MD, PhD principal investigator
Chang Gung Memorial Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing cabotegravir/rilpivirine (600mg/ 900mg) and Antiretroviral Combinations in people with HIV-1-infection and Non-Adherence, Medication, run by Chang Gung Memorial Hospital at 4 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HIV-1 RNA <200 copies/mL (time frame: Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.