CROWN - A Phase 3b, open label, randomized, standard-of care control arm, multicenter, superiority study evaluating the efficacy, safety and tolerability of injectable CAB LA + RPV LA in viremic participants living with HIV-1
Sponsor: |
GSK |
Enrolling: |
Male and Female Patients |
Study Length: |
24 Months |
Clinic Visits: |
19 |
IRB Number: |
AAAV3525 |
U.S. Govt. ID: |
NCT06694805 |
Contact: |
Max Flanagan: 212-305-7897 / mhf2142@cumc.columbia.edu |
This trial is testing an experimental treatment for HIV that is called CAB + RPV LA (long-acting cabotegravir and rilpivirine). CAB + RPV LA is a combination of drugs that is used to treat HIV (called antiretroviral therapy ART). It is currently approved in the US for the treatment of people living with HIV who are taking ART and whose viral load is already undetectable. This trial is a Phase 3b study testing whether CAB + RPV LA is effective at reducing HIV viral load to undetectable levels in people who currently have a detectable viral load despite being prescribed oral ART. This trial will evaluate whether CAB + RPV LA is better than oral ART at reducing HIV viral load to undetectable levels in people living with HIV for whom oral ART is not optimal. It will also examine the long-term effectiveness of CAB + RPV LA and whether it is safe for up to 24 months. In addition, this trial will look at some other aspects of taking CAB + RPV LA that are important to people living with HIV. You may be eligible for this study if you are 18 years of age or older, are HIV positive, are currently on an oral ART regimen that isn't optimal for you, and the levels of HIV in your blood are still detectable. You may not be eligible for this study if you have a certain subtype of HIV called A6, are pregnant or breastfeeding, or have certain medical conditions or sensitivities to certain medications. If you participate in this trial, you will be randomly assigned to either receive injections of CAB + RPV LA or to an oral ART regimen, either your current regimen or a new regimen prescribed by the study doctor. Your participation will last up to 24 months and include up to 19 clinic visits. Procedures during trial participation would include injections of the CAB + RPV LA or taking oral ART, testing for HIV and associated conditions, physical exams, collection of blood, pregnancy testing, exams of your heart function using an electrocardiogram (ECG), and completion of questionnaires.
Investigator
Magdalena Sobieszczyk, MD
Are you currently living with HIV? |
Yes |
No |
Do you currently have a seizure disorder? |
Yes |
No |
Have you previously taken the medication cabotegravir? |
Yes |
No |