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Common TitleFTC-301A Industry
Official Title A Randomized, Double-Blind, Equivalence Trial Comparing Emtricitabine to Stavudine Within a Triple Drug Combination Containing Didanosine Plus Efavirenz in Antiretroviral-Drug Naive HIV-1 Infected Patients
Phase Phase III
ClinicalTrials.gov NCT00006208
Treatments
Emtricitabine
Emtricitabine
Tradename:EmtrivaOther Names:FTCClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Categories Treatment-Naive
Funding
IndustryTriangle Pharmaceuticals
References
- Saag MS, Cahn P, Raffi F, et al. Efficacy and safety of emtricitabine vs stavudine in combination therapy in antiretroviral-naive patients: a randomized trial. JAMA. 2004;292:180-9.
Common TitleFTC-303/FTC-350 Industry
Official Title A Randomized, Open-Label Equivalence Study of FTC Versus Lamivudine in Patients on a Stable Triple Antiretroviral Therapy Regimen Containing Lamivudine, Stavudine or Zidovudine, and a Protease Inhibitor or Non-Nucleoside Reverse Transcriptase Inhibitor
Phase Phase III
ClinicalTrials.gov NCT00002416
Treatments
Emtricitabine
Emtricitabine
Tradename:EmtrivaOther Names:FTCClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Categories Treatment-ExperiencedSwitch/Simplification
Funding
IndustryGilead Sciences
References
- Benson CA, van der Horst C, Lamarca A, et al. A randomized study of emtricitabine and lamivudine in stably suppressed patients with HIV. AIDS. 2004;18:2269-76.
Official Title A Phase 3, Randomized, Multicenter Study of the Treatment of Antiretroviral-Naive HIV-1 Infected Subjects Comparing Tenofovir Disoproxil Fumarate and Emtricitabine in Combination With Efavirenz vs Combivir (Lamivudine/Zidovudine) and Efavirenz
Phase Phase III
ClinicalTrials.gov NCT00112047
Treatments
Zidovudine
, Zidovudine
Tradename:RetrovirOther Names:ZDVClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Efavirenz
, Efavirenz
Tradename:SustivaOther Names:EFVClass:Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)Emtricitabine
, Emtricitabine
Tradename:EmtrivaOther Names:FTCClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Zidovudine-Lamivudine
, Zidovudine-Lamivudine
Tradename:CombivirOther Names:ZDV-3TCClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Efavirenz-Tenofovir DF-Emtricitabine
Efavirenz-Tenofovir DF-Emtricitabine
Tradename:AtriplaOther Names:EFV-TDF-FTC, Efavirenz-Tenofovir disoproxil fumarate-EmtricitabineClass:Single-Tablet RegimensCategories Treatment-NaiveResistance/Virological Failure
Funding
IndustryGilead Sciences
References
- Arribas JR, Pozniak AL, Gallant JE, et al. Tenofovir disoproxil fumarate, emtricitabine, and efavirenz compared with zidovudine/lamivudine and efavirenz in treatment-naive patients: 144-week analysis. J Acquir Immune Defic Syndr. 2008;47:74-8.
- Gallant JE, DeJesus E, Arribas JR, et al. Tenofovir DF, emtricitabine, and efavirenz vs. zidovudine, lamivudine, and efavirenz for HIV. N Engl J Med. 2006;354:251-60.
- Margot NA, Enejosa J, Cheng AK, Miller MD, McColl DJ; Study 934 Team. Development of HIV-1 drug resistance through 144 weeks in antiretroviral-naïve subjects on emtricitabine, tenofovir disoproxil fumarate, and efavirenz compared with lamivudine/zidovudine and efavirenz in study GS-01-934. J Acquir Immune Defic Syndr. 2009;52:209-21.
- Pozniak AL, Gallant JE, DeJesus E, et al. Tenofovir disoproxil fumarate, emtricitabine, and efavirenz versus fixed-dose zidovudine/lamivudine and efavirenz in antiretroviral-naive patients: virologic, immunologic, and morphologic changes--a 96-week analysis. J Acquir Immune Defic Syndr. 2006;43:535-40.
Common TitleMONTANA Non-Industry
Official Title Pilot Study on Efficacy and Safety of a Once Daily FTC, ddI, Efavirenz Combination in Antiretroviral Naive HIV Infected Adults. ANRS 091 MONTANA
Phase Phase II
ClinicalTrials.gov NCT00196599
Treatments
Emtricitabine
Emtricitabine
Tradename:EmtrivaOther Names:FTCClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Categories Treatment-NaivePharmacologyGeneral Pharmacology
Funding
Non-IndustryFrench National Agency for Research on AIDS and Viral Hepatitis
References
- Molina JM, Ferchal F, Rancinan C, et al. Once-daily combination therapy with emtricitabine, didanosine, and efavirenz in human immunodeficiency virus-infected patients. J Infect Dis. 2000;182:599-602.
- Molina JM, Peytavin G, Perusat S, et al. Pharmacokinetics of emtricitabine, didanosine and efavirenz administered once-daily for the treatment of HIV-infected adults (pharmacokinetic substudy of the ANRS 091 trial). HIV Med. 2004;5:99-104.