Phenotypic resistance (PR) was analyzed in participants who met CVF criteria.
ATLAS FREE TRIAL PLUS
This will be an open-label study and therefore no blinding is requiredĪ Phase IIIb, Randomized, Multicenter, Parallel-group, Non-inferiority, Open-label Study Evaluating the Efficacy, Safety, and Tolerability of Long-acting Cabotegravir Plus Long-acting Rilpivirine Administered Every 8 Weeks or Every 4 Weeks in HIV-1-infected Adults Who Are Virologically Suppressed Two groups of subjects will be randomized to receive CAB LA + RPV LA Q4W, or CAB LA + RPV LA Q8W regimen Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information Condition or diseaseĭrug: Cabotegravir Tablets Drug: Rilpivirine Tablets Drug: Cabotegravir Injectable Suspension Drug: Rilpivirine Injectable Suspension Subjects choosing not to enter the Extension phase can complete their study participation at the Week 100 visit and enter into the 52-week Long-Term Follow-Up (LTFU) Phase as required. The study will be carried out in 3 phases including screening phase, maintenance phase and extension phase. Subjects in both groups will be randomized to receive CAB LA + RPV LA Q4W or Q8W.
Subjects will be divided in 2 groups Group 1 will include subjects receiving current anti-retroviral (ART) standard of care (SOC) therapy whereas group 2 will include subjects currently receiving CAB LA + RPV LA Q4W in ATLAS study. This Antiretroviral Therapy as Long Acting Suppression every 2 Months (ATLAS-2M) study is designed to demonstrate the non-inferior antiviral activity and safety of CAB LA + RPV LA administered every 8 weeks (Q8W) compared to CAB LA + RPV LA administered every 4 weeks (Q4W) over a 48-week treatment period in approximately 1020 adult HIV-1 infected subjects.
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