At a glance
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A Phase III Study to Evaluate Long-Acting Antiretroviral Therapy in Non-Adherent HIV-Infected Individuals
In Brief
A Phase 3 clinical trial evaluating Standard of Care (SOC) Oral ART, Oral RPV, and 5 other interventions for HIV Infections. Active but no longer recruiting, targeting 456 participants across 33 sites in 2 countries.
Signals
Detailed Summary
The purpose of this study was to compare the efficacy, safety, and durability of two different strategies to treat participants with a history of sub-optimal adherence and control of their HIV infection: long-acting (LA) antiretroviral therapy (ART) and all-oral standard of care (SOC).
Study Details
Timeline
Arms & Interventions
In Step 1, participants received SOC oral ART regimen for up to 24 weeks.
In Step 2, participants received oral RPV once daily and oral CAB once daily for 4 weeks (optional), followed by a RPV-LA loading dose and a CAB-LA loading dose, followed in 4 weeks by an RPV-LA maintenance dose and a CAB-LA maintenance dose every 4 weeks for 44 weeks.
In Step 2, participants continued SOC oral ART regimen for 52 weeks.
Interventions
SOC oral ART regimen must include at least 3 drugs with 2 or more drugs predicted to be fully active, including a boosted protease inhibitor (PI) and/or an integrase strand transfer inhibitor (INSTI)
RPV 25 mg tablets
CAB 30 mg tablets
900 mg administered as one 3 mL (900 mg) intramuscular injection in the gluteal muscle
600 mg administered as one 3 mL (600 mg) intramuscular injection in the gluteal muscle
600 mg administered as one 2 mL (600 mg) intramuscular injection in the gluteal muscle
400 mg administered as one 2 mL (400 mg) intramuscular injection in the gluteal muscle