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Common TitleSTaR
Official Title A Phase 3B, Randomized, Open-label Study to Evaluate the Safety and Efficacy of a Single Tablet Regimen of Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate Compared With a Single Tablet Regimen of Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults
Phase Phase IIIB
ClinicalTrials.gov NCT01309243
Treatments
Efavirenz-Tenofovir DF-Emtricitabine
Efavirenz-Tenofovir DF-Emtricitabine Atripla

Efavirenz-Tenofovir DF-Emtricitabine

Tradename:AtriplaOther Names:EFV-TDF-FTC, Efavirenz-Tenofovir disoproxil fumarate-EmtricitabineClass:Single-Tablet Regimens
,
Rilpivirine-Tenofovir DF-Emtricitabine
Rilpivirine-Tenofovir DF-Emtricitabine Complera

Rilpivirine-Tenofovir DF-Emtricitabine

Tradename:CompleraOther Names:RPV-TDF-FTC, Rilpivirine-Tenofovir disoproxil fumarate-EmtricitabineClass:Single-Tablet Regimens
Categories Treatment-NaiveResistance/Virological FailurePharmacologyAdverse Effects
Funding
IndustryGilead Sciences
References
  • Cohen C, Wohl D, Arribas JR, et al. Week 48 results from a randomized clinical trial of rilpivirine/emtricitabine/tenofovir disoproxil fumarate vs. efavirenz/emtricitabine/tenofovir disoproxil fumarate in treatment-naive HIV-1-infected adults. AIDS. 2014;28:989-97.
    [PubMed Abstract]
  • Porter DP, Daeumer M, Thielen A, et al. Emergent HIV-1 Drug Resistance Mutations Were Not Present at Low-Frequency at Baseline in Non-Nucleoside Reverse Transcriptase Inhibitor-Treated Subjects in the STaR Study. Viruses. 2015;7:6360-70.
    [PubMed Abstract]
  • Porter DP, Kulkarni R, Fralich T, Miller MD, White KL. 96-week resistance analyses of the STaR study: rilpivirine/emtricitabine/tenofovir DF versus efavirenz/emtricitabine/tenofovir DF in antiretroviral-naive, HIV-1-infected subjects. HIV Clin Trials. 2015;16:30-8.
    [PubMed Abstract]
  • Porter DP, Kulkarni R, Fralich T, Miller MD, White KL. Characterization of HIV-1 drug resistance development through week 48 in antiretroviral naive subjects on rilpivirine/emtricitabine/tenofovir DF or efavirenz/emtricitabine/tenofovir DF in the STaR study (GS-US-264-0110). J Acquir Immune Defic Syndr. 2014;65:318-26.
    [PubMed Abstract]
  • van Lunzen J, Antinori A, Cohen CJ, et al. Rilpivirine vs. efavirenz-based single-tablet regimens in treatment-naive adults: week 96 efficacy and safety from a randomized phase 3b study. AIDS. 2016;30:251-9.
    [PubMed Abstract]
  • Wilkins EL, Cohen CJ, Trottier B, et al. Patient-reported outcomes in the single-tablet regimen (STaR) trial of rilpivirine/emtricitabine/tenofovir disoproxil fumarate versus efavirenz/emtricitabine/tenofovir disoproxil fumarate in antiretroviral treatment-naive adults infected with HIV-1 through 48 weeks of treatment. AIDS Care. 2016;28:401-8.
    [PubMed Abstract]

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