Health TrialsbyHealthPanel

Outcomes of the PLHIV With Suboptimal Viral Suppression to Injectable Long-acting Antiretrovirals

ConditionsHIV-1-infectionNon-Adherence, Medication
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorChang Gung Memorial Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • cabotegravir/rilpivirine (600mg/ 900mg)

    Drug

    Immediate switch from oral antiretroviral to long-acting injectables

  • Antiretroviral Combinations

    Drug

    Standard all-oral antiretroviral combinations

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Immediate Long-Acting Injectable Treatment GroupExperimental treatment 1 intervention
Group B: Delayed Long-Acting Injectable Treatment GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

Change of plasma HIV-1 viral load

Change of plasma HIV-1 RNA at week 24, 52

Time frame
Week 24, week 52
4

Change of CD4 count

Change of CD4 count at week 24, 52

Time frame
Week 24, week 52

Other outcomes

1

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
2

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.
3

Delayed injections

Percentage of delayed injections (\>7 days after the target visit)

Time frame
up to week 52
4

HIV-1 RNA <50 copies/mL

Percentage of study participants with plasma HIV-1 RNA \<50 copies/mL

Time frame
Week 72, week 96

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chang Gung Memorial Hospital

Lead sponsor

Taoyuan General Hospital

Collaborator

Source ClinicalTrials.gov
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