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| ID | Type | Description | Link |
|---|---|---|---|
| MOHW113-CDC-C-114-000106 | Other Grant/Funding Number | Taiwan Centers for Disease Control |
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| Name | Class |
|---|---|
| Taoyuan General Hospital | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate Long-Acting Injectable Treatment Group | Experimental | Immediate switch to long-acting injectable antiretrovirals on enrollment |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cabotegravir/rilpivirine (600mg/ 900mg) | Drug | Immediate switch from oral antiretroviral to long-acting injectables |
|
| Measure | Description | Time Frame |
|---|---|---|
| HIV-1 RNA <200 copies/mL | Percentage of study participants with plasma HIV-1 RNA <200 copies/mL at week 24 | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nan-Yu Chen, MD, PhD | Contact | +886 3 3281200 | 8450 | nanyuchen@cgmh.org.tw |
| Name | Affiliation | Role |
|---|---|---|
| Nan-Yu Chen, MD, PhD | Chang Gung Memorial Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chang Gung Memorial Hospital, Keelung | Recruiting | Keelung | 204 | Taiwan |
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|
| Antiretroviral Combinations | Drug | Standard all-oral antiretroviral combinations |
|
| 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 |
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 |
| Chang Gung Memorial Hospital, Taipei | Recruiting | Taipei | 105 | Taiwan |
|
| Taoyuan General Hospital, Ministry of Health and Welfare | Recruiting | Taoyuan | 330 | Taiwan |
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| Chang Gung Memorial Hospital, Linkou | Recruiting | Taoyuan | 333 | Taiwan |
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| ID | Term |
|---|---|
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| C584914 | cabotegravir |
| D000068696 | Rilpivirine |
| C000712547 | cabotegravir, rilpivirine drug combination |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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