Common TitleStudy 121 (STRATEGY-NNRTI)
Official Title A Phase 3b Randomized, Open Label Study to Evaluate Switching From Regimens Consisting of a Non-nucleoside Reverse Transcriptase Inhibitor (NNRTI) Plus Emtricitabine (FTC) and Tenofovir DF (TDF) to the Elvitegravir/Cobicistat/ Emtricitabine/Tenofovir Disoproxil Fumarate Single-Tablet Regimen (EVG/COBI/FTC/TDF) in Virologically Suppressed, HIV 1 Infected Patients
Phase Phase IIB
ClinicalTrials.gov NCT01495702
Treatments
Elvitegravir-Cobicistat-Tenofovir DF-Emtricitabine
Elvitegravir-Cobicistat-Tenofovir DF-Emtricitabine
Tradename:StribildOther Names:EVG-COBI-TDF-FTCClass:Single-Tablet RegimensCategories PharmacologyTreatment-ExperiencedSwitch/SimplificationAdverse Effects
Funding
IndustryGilead Sciences
References
- Mills A, Garner W, Pozniak A, et al. Patient-Reported Symptoms Over 48 Weeks in a Randomized, Open-Label, Phase IIIb Non-Inferiority Trial of Adults with HIV Switching to Co-Formulated Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir DF versus Continuation of Non-Nucleoside Reverse Transcriptase Inhibitor with Emtricitabine and Tenofovir DF. Patient. 2015;8:359-71.
- Pozniak A, Markowitz M, Mills A, et al. Switching to coformulated elvitegravir, cobicistat, emtricitabine, and tenofovir versus continuation of non-nucleoside reverse transcriptase inhibitor with emtricitabine and tenofovir in virologically suppressed adults with HIV (STRATEGY-NNRTI): 48 week results of a randomised, open-label, phase 3b non-inferiority trial. Lancet Infect Dis. 2014;14:590-9.
- Stellbrink HJ, Antinori A, Pozniak A, et al. Switch to Stribild versus continuation of NVP or RPV with FTC and TDF in virologically suppressed HIV adults: a STRATEGY-NNRTI subgroup analysis. J Int AIDS Soc. 2014;17:19793.