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PH 3b, CAB + RPV in people with suboptimal response to oral ART (CROWN)
EU CTIS ID: 2024-515070-28-00
What this study is testing
To demonstrate a superior viral suppression rate after 6 months of CAB LA + RPV LA, administered every 2 months, compared with oral ART in treatment experienced PWH with viremia
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Aged at least 12 years old and weighting at least 35 kg
- Documented HIV-1 infection with plasma HIV-1 RNA >1,000 and <100,000 c/mL
- Evidence of insufficient virologic response to participant's current oral ART regimen (defined as participant having an active prescription) within 18 months before study entry according to at least 1 of the following criteria: i. <1 log10 decrease in HIV-1 RNA or HIV-1 RNA >200 c/mL at 2 time points at least 4 weeks apart in individuals who have been prescribed oral ART for at least 3 consecutive months. ii. Documented lapse in current oral ART regimen usage expected to result in HIV-1 viremia (defined as at least a 30-day consecutive period of non-use of oral ART) iii. Documented need for change from oral ART regimen that investigator attributes as primary reason for insufficient virologic response (e.g., safety findings and/or limited tolerability, clinically relevant DDIs)
- Currently being treated with/prescribed an oral ART regimen and willing to continue taking an oral ART regimen until after their Month 6 viral load result is available.
- Participant (if aged 18+) or a participant's parent/legal guardian is able to give signed informed consent. Where applicable an adolescent participant is able to assent to participate in the study.
- Staff study participants are eligible to participate if they are responsible for/involved in adherence support for CAB + RPV LA, are able to agree to and have the time to participate in interviews and questionnaire completion, and have the cognitive ability to complete questionnaires and take part in an interview that may take up to 60 minutes.
You likely can't join if
- HIV-1 subtype A6
- Any previous use of CAB
- Current or recent use of medications prohibited or defined as exclusionary in the protocol.
- Exposure to an experimental drug or experimental vaccine within either 28 days, 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent, whichever is longer, prior to the first dose of study medication.
- Current or anticipated participation in another interventional study.
- Evidence of viral drug resistance to INSTIs or NNRTIs at Screening or in any historical resistance test result.
See the full eligibility criteria
Who can join
- Aged at least 12 years old and weighting at least 35 kg
- Documented HIV-1 infection with plasma HIV-1 RNA >1,000 and <100,000 c/mL
- Evidence of insufficient virologic response to participant's current oral ART regimen (defined as participant having an active prescription) within 18 months before study entry according to at least 1 of the following criteria: i. <1 log10 decrease in HIV-1 RNA or HIV-1 RNA >200 c/mL at 2 time points at least 4 weeks apart in individuals who have been prescribed oral ART for at least 3 consecutive months. ii. Documented lapse in current oral ART regimen usage expected to result in HIV-1 viremia (defined as at least a 30-day consecutive period of non-use of oral ART) iii. Documented need for change from oral ART regimen that investigator attributes as primary reason for insufficient virologic response (e.g., safety findings and/or limited tolerability, clinically relevant DDIs)
- Currently being treated with/prescribed an oral ART regimen and willing to continue taking an oral ART regimen until after their Month 6 viral load result is available.
- Participant (if aged 18+) or a participant's parent/legal guardian is able to give signed informed consent. Where applicable an adolescent participant is able to assent to participate in the study.
- Staff study participants are eligible to participate if they are responsible for/involved in adherence support for CAB + RPV LA, are able to agree to and have the time to participate in interviews and questionnaire completion, and have the cognitive ability to complete questionnaires and take part in an interview that may take up to 60 minutes.
What rules you out
- HIV-1 subtype A6
- Any previous use of CAB
- Current or recent use of medications prohibited or defined as exclusionary in the protocol.
- Exposure to an experimental drug or experimental vaccine within either 28 days, 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent, whichever is longer, prior to the first dose of study medication.
- Current or anticipated participation in another interventional study.
- Evidence of viral drug resistance to INSTIs or NNRTIs at Screening or in any historical resistance test result.
- Has exclusionary safety laboratory test results at Screening
- QTc >450 msec or >480 msec for participants with bundle branch block at Screening
- Unwilling to receive injections or unable to receive gluteal injections.
- Participant has gluteal implants or prosthesis; or a tattoo or other dermatological condition in the gluteus region which may interfere with interpretation of injection site reactions.
- Evidence of alcohol or substance use disorder within the previous 12 months, as assessed by the Investigator using standard methods for their site, that would interfere with the participant's safety.
- Participants who are pregnant, breast/chest feeding or plan to become pregnant or breast/chest feed during the study
- Adolescents who are wards of the state.
- Staff study participants will be excluded if they are not involved in adherence support for viremic patients on CAB + RPV LA or if they are unwilling to be audio recorded during the interviews.
- Unstable liver disease or a history of liver cirrhosis with or without hepatitis viral co-infection.
- Co-infection with Hepatitis B where they would not be able to receive appropriate therapy for their HBV co-infection or with Hepatitis C if they are currently receiving anti-HCV therapy at Day 1
- Participants with severe hepatic impairment (Class C) as determined by Child-Pugh classification.
- Participants with a high risk of seizures, including those with an unstable or poorly controlled seizure disorder.
- High sensitivity to any of the study medications or their components or drugs of their class, or a history of drug or other allergy that contraindicates their participation.
- Participants who pose a significant suicidality risk. History of suicidal behavior and/or suicidal ideation should be considered when assessing suicide risk.
- Pre-existing physical or mental condition that may interfere with the participant's ability to comply with the dosing schedule and/or protocol assessments, or which may compromise participant safety.
The study team makes the final eligibility decision.
Where it's taking place
- United States
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, 65+ years, 0-17 years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States. 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 EU CTIS; the study team decides eligibility.