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New treatment option for HIV-1 Infected Adults with Controlled Viremia
Official title Long Acting Cabotegravir Plus Rilpivirine in People Living with HIV-1 Aged ≥ 60 Years for 24 Months.
ClinicalTrials.gov ID: NCT06646562
What this study is testing
What is Cabotegravir LA + Rilpivirine LA?
Cabotegravir LA + Rilpivirine LA is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for hiv-1 infected adults with controlled viremia.
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
- People Living with HIV-1 (PLHIV) are an important group of patients attending their specialist's and continue growing thanks to efficacy antiretroviral treatment (ART), allowing them to stabilize the HIV-infection and to live a normal life despite the infection. The present study is encouraged to demonstrate that efficacy and security of CAB LA + RPV LA treatment's on this population remains the same compared to younger population of patients.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 and older
You may be able to join if
- Be able to understand and comply with protocol requirements, instructions, and restrictions.
- Understand the long-term commitment to the study and be likely to complete the study as planned.
- Be considered appropriate candidates for participation in an investigative clinical trial with oral and intramuscularly injectable medications (e.g...
- Must be on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with agents of...
- Plasma HIV-1 RNA \<50 copies/mL at screening.
You likely can't join if
- Plasma HIV-1 RNA measurement ≥50 copies/mL within 6 months prior to screening. Blips are allowed (increased viral load ≥50 copies/mL but \<200...
- Any drug holiday during the window between initiating first HIV ART and 6 months prior to screening, except for brief periods (less than 1 month)...
- Any switch to a second line regimen, defined as change of a single drug or multiple drugs simultaneously, due to virologic failure to NNRTI or INSTI...
- people who are currently participating in or anticipate being selected for any other treatment study. Observational studies and intervention studies...
- Participants receiving any prohibited medication and who are unwilling or unable to switch to an alternative medication
See the full eligibility criteria
- Be able to understand and comply with protocol requirements, instructions, and restrictions.
- Understand the long-term commitment to the study and be likely to complete the study as planned.
- Be considered appropriate candidates for participation in an investigative clinical trial with oral and intramuscularly injectable medications (e.g., no active substance use disorder, acute major organ disease, or...
- Must be on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with agents of the NNRTI and INI class.
- Plasma HIV-1 RNA \<50 copies/mL at screening.
- A female subject is eligible to participate if she is not pregnant (as confirmed by a negative serum hCG test at screen and a negative urine hCG test at randomization) and not lactating
- Plasma HIV-1 RNA measurement ≥50 copies/mL within 6 months prior to screening. Blips are allowed (increased viral load ≥50 copies/mL but \<200 copies/mL preceded and followed by a viral load less than 50 copies/mL)
- Any drug holiday during the window between initiating first HIV ART and 6 months prior to screening, except for brief periods (less than 1 month) where all ART was stopped due to side effects and/or safety concerns.
- Any switch to a second line regimen, defined as change of a single drug or multiple drugs simultaneously, due to virologic failure to NNRTI or INSTI (defined as a confirmed plasma HIV-1 RNA measurement ≥200 copies/mL...
- people who are currently participating in or anticipate being selected for any other treatment study. Observational studies and intervention studies that do not include treatments are allowed unless they interfere with...
- Participants receiving any prohibited medication and who are unwilling or unable to switch to an alternative medication
The study team makes the final eligibility decision.
Where it's taking place
- Elche, Alicante, Spain
- Villajoyosa, Alicante, Spain
- Cartagena, Murcia, Spain
- Lorca, Murcia, Spain
- Murcia, Murcia, Spain
- Pozo-Aledo, Murcia, Spain
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, 60 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Elche, Alicante, Spain; Villajoyosa, Alicante, Spain; Cartagena, Murcia, Spain; Lorca, Murcia, Spain; Murcia, Murcia, Spain; Pozo-Aledo, Murcia, Spain. 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.