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New treatment option for HIV-1-infection
Official title Outcomes of the PLHIV With Suboptimal Viral Suppression to Injectable Long-acting Antiretrovirals
ClinicalTrials.gov ID: NCT06507059
What this study is testing
What is cabotegravir/rilpivirine (600mg/ 900mg)?
cabotegravir/rilpivirine (600mg/ 900mg) is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for hiv-1-infection.
Also referred to as Cabenuva.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
You likely can't join if
- For those currently undergoing oral antiretroviral therapy, who have started or restarted oral ART for less than six consecutive months before...
- 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...
- Individuals with buttock fillers.
- Women who are planning to become pregnant, pregnant, or currently breastfeeding.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Keelung, Taiwan
- Taipei, Taiwan
- Taoyuan, Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Keelung, Taiwan; Taipei, Taiwan; Taoyuan, Taiwan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.