Common TitleSPIRIT
Official Title A Phase 3 Randomized, Open Label Study to Evaluate Switching From Regimens Consisting of a Ritonavir-boosted Protease Inhibitor and Two Nucleoside Reverse Transcriptase Inhibitors to Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate (FTC/RPV/TDF) Fixed-dose Regimen in Virologically Suppressed, HIV-1 Infected Patients
Phase Phase III
ClinicalTrials.gov NCT01252940
Treatments
Rilpivirine-Tenofovir DF-Emtricitabine
Rilpivirine-Tenofovir DF-Emtricitabine
Tradename:CompleraOther Names:RPV-TDF-FTC, Rilpivirine-Tenofovir disoproxil fumarate-EmtricitabineClass:Single-Tablet RegimensCategories PharmacologyTreatment-ExperiencedAdverse EffectsSwitch/SimplificationResistance/Virological Failure
Funding
IndustryGilead Sciences
References
- Brunetta J, Moreno Guillén S, Antinori A, et al. Patient-Reported Outcomes After a Switch to a Single-Tablet Regimen of Rilpivirine, Emtricitabine, and Tenofovir DF in HIV-1-Positive, Virologically Suppressed Individuals: Additional Findings From a Randomized, Open-Label, 48-Week Trial. Patient. 2015;8:257-67.
- Palella FJ Jr, Fisher M, Tebas P, et al. Simplification to rilpivirine/emtricitabine/tenofovir disoproxil fumarate from ritonavir-boosted protease inhibitor antiretroviral therapy in a randomized trial of HIV-1 RNA-suppressed participants. AIDS. 2014;28:335-44.
- Porter DP, Toma J, Tan Y, et al. Clinical Outcomes of Virologically-Suppressed Patients with Pre-existing HIV-1 Drug Resistance Mutations Switching to Rilpivirine/Emtricitabine/Tenofovir Disoproxil Fumarate in the SPIRIT Study. HIV Clin Trials. 2016;17:29-37.