Bictegravir-Tenofovir alafenamide-Emtricitabine Biktarvy
Darunavir-Cobicistat-Tenofovir alafenamide-Emtricitabine Symtuza
Dolutegravir-Abacavir-Lamivudine Triumeq
Dolutegravir-Lamivudine Dovato
Dolutegravir-Rilpivirine Juluca
Doravirine-Tenofovir DF-Lamivudine Delstrigo
Elvitegravir-Cobicistat-Tenofovir alafenamide-Emtricitabine Genvoya
Elvitegravir-Cobicistat-Tenofovir DF-Emtricitabine Stribild
Rilpivirine-Tenofovir alafenamide-Emtricitabine Odefsey
Enfuvirtide Fuzeon
Fostemsavir Rukobia
Ibalizumab Trogarzo
Maraviroc Selzentry
Dolutegravir Tivicay
Raltegravir Isentress
Didanosine Videx
Lamivudine Epivir
Tenofovir alafenamide-Emtricitabine Descovy
Doravirine Pifeltro
Etravirine Intelence
Nevirapine Viramune
Atazanavir Reyataz
Atazanavir-Cobicistat Evotaz
Darunavir Prezista
Darunavir-Cobicistat Prezcobix
Saquinavir Invirase
Tipranavir Aptivus
Cobicistat Tybost
Ritonavir NorvirAll Clinical Trials
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Official Title A Phase III, Multicenter, Randomized, Open-Label Study to Compare Antiretroviral Activity and Tolerability of Three Different Combination Regimens (Efavirenz [DMP 266] + Indinavir, Efavirenz [DMP 266] + Zidovudine + Lamivudine, Indinavir + Zidovudine + Lamivudine) in HIV-Infected Patients
Phase Phase III
ClinicalTrials.gov NCT00002410
Treatments
Indinavir
, Indinavir
Tradename:CrixivanOther Names:IDVClass:Protease Inhibitors (PI)Efavirenz
Efavirenz
Tradename:SustivaOther Names:EFVClass:Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)Categories Treatment-NaiveTreatment-Experienced
Funding
IndustryDupont Merck
References
- Staszewski S, Morales-Ramirez J, Tashima KT, et al. Efavirenz plus zidovudine and lamivudine, efavirenz plus indinavir, and indinavir plus zidovudine and lamivudine in the treatment of HIV-1 infection in adults. Study 006 Team. N Engl J Med. 1999;341:1865-73.
Common Title903E Industry
Official Title A Phase 3, Randomized, Double-Blind, Multicenter Study of the Treatment of Antiretroviral-naive, HIV-1-Infected Patients Comparing Tenofovir Disoproxil Fumarate Administered in Combination With Lamivudine and Efavirenz vs. Stavudine, Lamivudine and Efavirenz.(Extension)
Phase Phase III
ClinicalTrials.gov NCT00158821
Treatments
Stavudine
, Stavudine
Tradename:ZeritOther Names:d4TClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Efavirenz
, Efavirenz
Tradename:SustivaOther Names:EFVClass:Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)Tenofovir DF
Tenofovir DF
Tradename:VireadOther Names:TDF, tenofovir disoproxil fumarateClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Categories PharmacologySwitch/SimplificationAdverse Effects
Funding
IndustryGilead Sciences
References
- Madruga JR, Cassetti I, Suleiman JM, et al. The safety and efficacy of switching stavudine to tenofovir df in combination with lamivudine and efavirenz in hiv-1-infected patients: three-year follow-up after switching therapy. HIV Clin Trials. 2007;8:381-90.
Common TitleACTG 384 Non-Industry
Official Title Study of Protease Inhibitor and/or Non-Nucleoside Reverse Transcriptase Inhibitor With Dual Nucleosides in Initial Therapy of HIV Infection
Phase Phase III
ClinicalTrials.gov NCT00000919
Treatments
Stavudine
, Stavudine
Tradename:ZeritOther Names:d4TClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Zidovudine
, Zidovudine
Tradename:RetrovirOther Names:ZDVClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Nelfinavir
, Nelfinavir
Tradename:ViraceptOther Names:NFVClass:Protease Inhibitors (PI)Efavirenz
, Efavirenz
Tradename:SustivaOther Names:EFVClass:Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)Zidovudine-Lamivudine
Zidovudine-Lamivudine
Tradename:CombivirOther Names:ZDV-3TCClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Categories PharmacologyTreatment-NaiveAdverse EffectsDrug InteractionsGeneral Pharmacology
Funding
Non-IndustryNational Institute of Allergy and Infectious Diseases (NIAID)
References
- Dubé MP, Komarow L, Mulligan K, et al. Long-term body fat outcomes in antiretroviral-naive participants randomized to nelfinavir or efavirenz or both plus dual nucleosides. Dual X-ray absorptiometry results from A5005s, a substudy of Adult Clinical Trials Group 384. J Acquir Immune Defic Syndr. 2007;45:508-14.
- Dubé MP, Parker RA, Tebas P, et al. Glucose metabolism, lipid, and body fat changes in antiretroviral-naive subjects randomized to nelfinavir or efavirenz plus dual nucleosides. AIDS. 2005;19:1807-18.
- Gandhi RT, Spritzler J, Chan E, et al. Effect of baseline- and treatment-related factors on immunologic recovery after initiation of antiretroviral therapy in HIV-1-positive subjects: results from ACTG 384. J Acquir Immune Defic Syndr. 2006;42:426-34.
- Robbins GK, De Gruttola V, Shafer RW, et al. Comparison of sequential three-drug regimens as initial therapy for HIV-1 infection. N Engl J Med. 2003;349:2293-303.
- Shafer RW, Smeaton LM, Robbins GK, et al. Comparison of four-drug regimens and pairs of sequential three-drug regimens as initial therapy for HIV-1 infection. N Engl J Med. 2003;349:2304-15.
- Smith PF, Robbins GK, Shafer RW, et al. Pharmacokinetics of nelfinavir and efavirenz in antiretroviral-naive, human immunodeficiency virus-infected subjects when administered alone or in combination with nucleoside analog reverse transcriptase inhibitors. Antimicrob Agents Chemother. 2005;49:3558-61.
Official Title A Phase III Randomized, Controlled Trial of Efavirenz (EFV) or Nelfinavir (NFV) in Combination With Fixed-Dose Combination Lamivudine/Zidovudine (3TC/ZDV) and Indinavir (IDV) in HIV-Infected Subjects With Less Than or Equal to 200 CD4 Cells/mm3 or Greater Than or Equal to 80,000 HIV RNA Copies/ml in Plasma
Phase Phase III
ClinicalTrials.gov NCT00000903
Treatments
Indinavir
, Indinavir
Tradename:CrixivanOther Names:IDVClass:Protease Inhibitors (PI)Nelfinavir
, Nelfinavir
Tradename:ViraceptOther Names:NFVClass:Protease Inhibitors (PI)Efavirenz
, Efavirenz
Tradename:SustivaOther Names:EFVClass:Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)Zidovudine-Lamivudine
Zidovudine-Lamivudine
Tradename:CombivirOther Names:ZDV-3TCClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Categories Resistance/Virological FailureTreatment-Experienced
Funding
Non-IndustryNational Institute of Allergy and Infectious Diseases (NIAID)
References
- Demeter LM, Ribaudo HJ, Erice A, et al. HIV-1 drug resistance in subjects with advanced HIV-1 infection in whom antiretroviral combination therapy is failing: a substudy of AIDS Clinical Trials Group Protocol 388. Clin Infect Dis. 2004;39:552-8.
- Fischl MA, Ribaudo HJ, Collier AC, et al. A randomized trial of 2 different 4-drug antiretroviral regimens versus a 3-drug regimen, in advanced human immunodeficiency virus disease. J Infect Dis. 2003;188:625-34.
Official Title Phase III, Randomized, Double-Blind Comparison of Three Protease Inhibitor-Sparing Regimens for the Initial Treatment of HIV Infection
Phase Phase III
ClinicalTrials.gov NCT00013520
Treatments
Efavirenz
, Efavirenz
Tradename:SustivaOther Names:EFVClass:Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)Abacavir-Lamivudine-Zidovudine
, Abacavir-Lamivudine-Zidovudine
Tradename:TrizivirOther Names:ABC-3TC-ZDVClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Zidovudine-Lamivudine
Zidovudine-Lamivudine
Tradename:CombivirOther Names:ZDV-3TCClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Categories Treatment-Naive
Funding
Non-IndustryNational Institute of Allergy and Infectious Diseases (NIAID)
References
- Gulick RM, Ribaudo HJ, Shikuma CM, et al. Triple-nucleoside regimens versus efavirenz-containing regimens for the initial treatment of HIV-1 infection. N Engl J Med. 2004;350:1850-61.
- Schackman BR, Ribaudo HJ, Krambrink A, Hughes V, Kuritzkes DR, Gulick RM. Racial differences in virologic failure associated with adherence and quality of life on efavirenz-containing regimens for initial HIV therapy: results of ACTG A5095. J Acquir Immune Defic Syndr. 2007;46:547-54.
Official Title A Randomized, Controlled Trial of Two Potent, Simplified Regimens Utilizing A Protease Inhibitor-Sparing Regimen Versus A Nucleoside-Sparing Regimen for HIV-Infected Subjects Who Participated in ACTG 388 or Who Responded to A First Potent Combination Regimen and Have 200 or Less HIV-1 RNA Copies/ml
Phase Phase III
ClinicalTrials.gov NCT00014937
Treatments
Lopinavir-Ritonavir
, Lopinavir-Ritonavir
Tradename:KaletraOther Names:LPV-RTVClass:Protease Inhibitors (PI)Efavirenz
Efavirenz
Tradename:SustivaOther Names:EFVClass:Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)Categories Treatment-ExperiencedSwitch/SimplificationDual TherapyPharmacologyAdverse Effects
Funding
Non-IndustryNational Institute of Allergy and Infectious Diseases (NIAID)
References
- Fischl MA, Collier AC, Mukherjee AL, et al. Randomized open-label trial of two simplified, class-sparing regimens following a first suppressive three or four-drug regimen. AIDS. 2007;21:325-33.
- Tebas P, Zhang J, Yarasheski K, et al. Switching to a protease inhibitor-containing, nucleoside-sparing regimen (lopinavir/ritonavir plus efavirenz) increases limb fat but raises serum lipid levels: results of a prospective randomized trial (AIDS clinical trial group 5125s). J Acquir Immune Defic Syndr. 2007;45:193-200.
Official Title A Phase III, Randomized, Open-Label Comparison of Lopinavir/Ritonavir Plus Efavirenz Versus Lopinavir/Ritonavir Plus 2 NRTIs Versus Efavirenz Plus 2 NRTIs as Initial Therapy for HIV-1 Infection
Phase Phase III
ClinicalTrials.gov NCT00050895
Treatments
Stavudine
, Stavudine
Tradename:ZeritOther Names:d4TClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Zidovudine
, Zidovudine
Tradename:RetrovirOther Names:ZDVClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Lopinavir-Ritonavir
, Lopinavir-Ritonavir
Tradename:KaletraOther Names:LPV-RTVClass:Protease Inhibitors (PI)Efavirenz
, Efavirenz
Tradename:SustivaOther Names:EFVClass:Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)Tenofovir DF
Tenofovir DF
Tradename:VireadOther Names:TDF, tenofovir disoproxil fumarateClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Categories PharmacologyTreatment-NaiveAdverse EffectsDual Therapy
Funding
Non-IndustryNational Institute of Allergy and Infectious Diseases (NIAID)
References
- Haubrich RH, Riddler SA, DiRienzo AG, et al. Metabolic outcomes in a randomized trial of nucleoside, nonnucleoside and protease inhibitor-sparing regimens for initial HIV treatment. AIDS. 2009;23:1109-18.
- Hulgan T, Haubrich R, Riddler SA, et al. European mitochondrial DNA haplogroups and metabolic changes during antiretroviral therapy in AIDS Clinical Trials Group Study A5142. AIDS. 2011;25:37-47.
- Riddler SA, Haubrich R, DiRienzo AG, et al. Class-sparing regimens for initial treatment of HIV-1 infection. N Engl J Med. 2008;358:2095-106.
Official Title A Phase IIIB, Randomized Trial of Open-Label Efavirenz or Atazanavir With Ritonavir in Combination With Double-Blind Comparison of Emtricitabine/Tenofovir or Abacavir/Lamivudine in Antiretroviral-Naive Subjects
Phase Phase IIIB
ClinicalTrials.gov NCT00118898
Treatments
Abacavir
, Abacavir
Tradename:ZiagenOther Names:ABCClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Abacavir-Lamivudine
, Abacavir-Lamivudine
Tradename:EpzicomOther Names:ABC-3TCClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Efavirenz
, Efavirenz
Tradename:SustivaOther Names:EFVClass:Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)Tenofovir DF-Emtricitabine
Tenofovir DF-Emtricitabine
Tradename:Truvada and Multiple GenericsOther Names:TDF-FTC, Tenofovir disoproxil fumarate-EmtricitabineClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Categories Treatment-NaiveResistance/Virological FailurePregnancy/Women
Funding
Non-IndustryNational Institute of Allergy and Infectious Diseases (NIAID)
References
- Daar ES, Tierney C, Fischl MA, et al. Atazanavir plus ritonavir or efavirenz as part of a 3-drug regimen for initial treatment of HIV-1. Ann Intern Med. 2011;154:445-56.
- Smith KY, Tierney C, Mollan K, et al. Outcomes by sex following treatment initiation with atazanavir plus ritonavir or efavirenz with abacavir/lamivudine or tenofovir/emtricitabine. Clin Infect Dis. 2014;58:555-63.
Official Title Study of Once-Daily Abacavir/Lamivudine Versus Tenofovir/Emtricitabine, Administered With Efavirenz in Antiretroviral-Naive, HIV-1 Infected Adult Subjects
Phase Phase IV
ClinicalTrials.gov NCT00549198
Treatments
Abacavir-Lamivudine
, Abacavir-Lamivudine
Tradename:EpzicomOther Names:ABC-3TCClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Efavirenz
, Efavirenz
Tradename:SustivaOther Names:EFVClass:Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)Tenofovir DF-Emtricitabine
, Tenofovir DF-Emtricitabine
Tradename:Truvada and Multiple GenericsOther Names:TDF-FTC, Tenofovir disoproxil fumarate-EmtricitabineClass: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 PharmacologyTreatment-NaiveAdverse Effects
Funding
IndustryGlaxoSmithKline
References
- Moyle GJ, Stellbrink HJ, Compston J, et al. 96-Week results of abacavir/lamivudine versus tenofovir/emtricitabine, plus efavirenz, in antiretroviral-naive, HIV-1-infected adults: ASSERT study. Antivir Ther. 2013;18:905-13.
- Post FA, Moyle GJ, Stellbrink HJ, et al. Randomized comparison of renal effects, efficacy, and safety with once-daily abacavir/lamivudine versus tenofovir/emtricitabine, administered with efavirenz, in antiretroviral-naive, HIV-1-infected adults: 48-week results from the ASSERT study. J Acquir Immune Defic Syndr. 2010;55:49-57.
- Stellbrink HJ, Orkin C, Arribas JR, et al. Comparison of changes in bone density and turnover with abacavir-lamivudine versus tenofovir-emtricitabine in HIV-infected adults: 48-week results from the ASSERT study. Clin Infect Dis. 2010;51:963-72.
Common TitleDART II Industry
Official Title Daily Antiretroviral Therapy (DART-II): An Open-Label, Single-Arm, Prospective, Multicenter Clinical Trial To Evaluate the Efficacy and Safety fo Stavudine Extended Release (d4T XR) in Combination With Lamivudine (3TC) and Efavirenz (EFV) Once Daily in Anti-Retroviral Therapy (ART) Naive HIV-Infected Subjects
Phase Phase IV
ClinicalTrials.gov NCT00116116
Treatments
Stavudine
, Stavudine
Tradename:ZeritOther Names:d4TClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Efavirenz
Efavirenz
Tradename:SustivaOther Names:EFVClass:Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)Categories Treatment-Naive
Funding
IndustryBristol-Myers Squibb
References
- Jayaweera D, Dejesus E, Nguyen KL, Grimm K, Butcher D, Seekins DW. Virologic suppression, treatment adherence, and improved quality of life on a once-daily efavirenz-based regimen in treatment-Naïve HIV-1-infected patients over 96 weeks. HIV Clin Trials. 2009;10:375-84.
Official Title A Phase III, Randomized, Double-blind Trial of Rilpivirine (TMC278) 25 mg q.d. Versus Efavirenz 600mg q.d. in Combination With a Fixed Background Regimen Consisting of Tenofovir Disoproxil Fumarate and Emtricitabine in Antiretroviral-naive HIV-1 Infected Subjects.
Phase Phase III
ClinicalTrials.gov NCT00540449
Treatments
Efavirenz
, Efavirenz
Tradename:SustivaOther Names:EFVClass:Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)Rilpivirine
, Rilpivirine
Tradename:EdurantOther Names:RPVClass:Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)Efavirenz-Tenofovir DF-Emtricitabine
, Efavirenz-Tenofovir DF-Emtricitabine
Tradename:AtriplaOther Names:EFV-TDF-FTC, Efavirenz-Tenofovir disoproxil fumarate-EmtricitabineClass:Single-Tablet RegimensRilpivirine-Tenofovir DF-Emtricitabine
Rilpivirine-Tenofovir DF-Emtricitabine
Tradename:CompleraOther Names:RPV-TDF-FTC, Rilpivirine-Tenofovir disoproxil fumarate-EmtricitabineClass:Single-Tablet RegimensFunding
IndustryTibotec Pharmaceuticals, Ireland
References
No references available for this clinical trial
Official Title A Randomised, Double-blind, Placebo-controlled, Clinical Trial to Compare the Safety and Efficacy of Reduced Dose Efavirenz (EFV) With Standard Dose EFV Plus Two Nucleotide Reverse Transcriptase Inhibitors (N(t)RTI) in Antiretroviral-naïve HIV-infected Individuals Over 96 Weeks
Phase Phase III
ClinicalTrials.gov NCT01011413
Treatments
Efavirenz
Efavirenz
Tradename:SustivaOther Names:EFVClass:Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)Categories PharmacologyTreatment-NaiveAdverse Effects
Funding
Non-IndustryKirby Institute
References
- ENCORE 1 Study Group, Puls R, Amin J, et al. Efficacy of 400 mg efavirenz versus standard 600 mg dose in HIV-infected, antiretroviral-naive adults (ENCORE1): a randomised, double-blind, placebo-controlled, non-inferiority trial. Lancet. 2014;383:1474-82.
- ENCORE1 Study Group, Carey D, Puls R, et al. Efficacy and safety of efavirenz 400 mg daily versus 600 mg daily: 96-week data from the randomised, double-blind, placebo-controlled, non-inferiority ENCORE1 study. Lancet Infect Dis. 2015;15:793-802.
- Winston A, Amin J, Clarke A, et al. Cerebrospinal fluid exposure of efavirenz and its major metabolites when dosed at 400 mg and 600 mg once daily: a randomized controlled trial. Clin Infect Dis. 2015;60:1026-32.
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.
Official Title Multicentre, Open Label, Prospective, Randomised Clinical Trial to Evaluate the Effectiveness of Abacavir 600 mg+ Lamivudine 300 mg as QD+ Efavirenz 600 mg QD Versus Kaletra 400/100 mg BID as Initial Antiretroviral Treatment
Phase Phase III
ClinicalTrials.gov NCT00318123
Treatments
Lopinavir-Ritonavir
, Lopinavir-Ritonavir
Tradename:KaletraOther Names:LPV-RTVClass:Protease Inhibitors (PI)Efavirenz
Efavirenz
Tradename:SustivaOther Names:EFVClass:Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)Categories Treatment-Naive
Funding
Non-IndustryGermans Trias i Pujol Hospital
References
- Echeverría P, Negredo E, Carosi G, et al. Similar antiviral efficacy and tolerability between efavirenz and lopinavir/ritonavir, administered with abacavir/lamivudine (Kivexa), in antiretroviral-naïve patients: a 48-week, multicentre, randomized study (Lake Study). Antiviral Res. 2010;85:403-8.
Official Title A Phase 4, Open Label, Randomized, Controlled Study to Assess the Effect on Lipid Profile of Switching From a Stable HAART Regimen of Fixed Dose Abacavir/Lamivudine (Kivexa) Plus Efavirenz, to Once Daily Atripla in Adult HIV-1 Infected Subjects With Raised Cholesterol
Phase Phase IV
ClinicalTrials.gov NCT00615810
Treatments
Abacavir-Lamivudine
, Abacavir-Lamivudine
Tradename:EpzicomOther Names:ABC-3TCClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Efavirenz
, Efavirenz
Tradename:SustivaOther Names:EFVClass:Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)Tenofovir DF-Emtricitabine
Tenofovir DF-Emtricitabine
Tradename:Truvada and Multiple GenericsOther Names:TDF-FTC, Tenofovir disoproxil fumarate-EmtricitabineClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Categories PharmacologyTreatment-ExperiencedSwitch/SimplificationAdverse Effects
Funding
IndustryGilead Sciences
References
- Moyle GJ, Orkin C, Fisher M, et al. A randomized comparative trial of continued abacavir/lamivudine plus efavirenz or replacement with efavirenz/emtricitabine/tenofovir DF in hypercholesterolemic HIV-1 infected individuals. PLoS One. 2015;10:e0116297.
Official Title A Study in Underrepresented Patient Population or Regimen Tolerability: SUPPoRT
Phase Phase III
ClinicalTrials.gov NCT00727597
Treatments
Fosamprenavir
, Fosamprenavir
Tradename:LexivaOther Names:FPVClass:Protease Inhibitors (PI)Efavirenz
Efavirenz
Tradename:SustivaOther Names:EFVClass:Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)Categories PharmacologyTreatment-NaiveAdverse Effects
Funding
Non-IndustryGeorgetown University
References
- Kumar P, DeJesus E, Huhn G, et al. Evaluation of cardiovascular biomarkers in a randomized trial of fosamprenavir/ritonavir vs. efavirenz with abacavir/lamivudine in underrepresented, antiretroviral-naïve, HIV-infected patients (SUPPORT): 96-week results. BMC Infect Dis. 2013;13:269.
Official Title A Phase III, Randomized, Double-blind Trial of Rilpivirine (TMC278) 25mg q.d. Versus Efavirenz 600mg q.d. in Combination With a Background Regimen Containing 2 Nucleoside/Nucleotide Reverse Transcriptase Inhibitors in Antiretroviral-naive HIV-1 Infected Subjects.
Phase Phase III
ClinicalTrials.gov NCT00543725
Treatments
Efavirenz
, Efavirenz
Tradename:SustivaOther Names:EFVClass:Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)Rilpivirine
Rilpivirine
Tradename:EdurantOther Names:RPVClass:Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)Categories Treatment-NaivePharmacologyAdverse EffectsResistance/Virological Failure
Funding
IndustryTibotec Pharmaceuticals, Ireland
References
- Cohen CJ, Andrade-Villanueva J, Clotet B, et al. Rilpivirine versus efavirenz with two background nucleoside or nucleotide reverse transcriptase inhibitors in treatment-naive adults infected with HIV-1 (THRIVE): a phase 3, randomised, non-inferiority trial. Lancet. 2011;378:229-37.
- Cohen CJ, Molina JM, Cahn P, et al. Efficacy and safety of rilpivirine (TMC278) versus efavirenz at 48 weeks in treatment-naive HIV-1-infected patients: pooled results from the phase 3 double-blind randomized ECHO and THRIVE Trials. J Acquir Immune Defic Syndr. 2012;60:33-42.
- Nelson MR, Elion RA, Cohen CJ, et al. Rilpivirine versus efavirenz in HIV-1-infected subjects receiving emtricitabine/tenofovir DF: pooled 96-week data from ECHO and THRIVE Studies. HIV Clin Trials. 2013;14:81-91.
- Rimsky L, Van Eygen V, Hoogstoel A, et al. 96-Week resistance analyses of rilpivirine in treatment-naive, HIV-1-infected adults from the ECHO and THRIVE Phase III trials. Antivir Ther. 2013;18:967-77.
- Tebas P, Sension M, Arribas J, et al. Lipid levels and changes in body fat distribution in treatment-naive, HIV-1-Infected adults treated with rilpivirine or Efavirenz for 96 weeks in the ECHO and THRIVE trials. Clin Infect Dis. 2014;59:425-34.
- Van Eygen V, Thys K, Van Hove C, et al. Deep sequencing analysis of HIV-1 reverse transcriptase at baseline and time of failure in patients receiving rilpivirine in the phase III studies ECHO and THRIVE. J Med Virol. 2016;88:798-806.
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Efavirenz Slide Deck
February 25, 2020
Clinical Trial Image Decks
ACTG 388 - February 25, 2020
ACTG 5095 - February 24, 2020
ACTG 5116 (and ACTG 5125s) - February 24, 2020
ACTG 5142 - February 24, 2020
ACTG 5202 - February 25, 2020
ASSERT - December 28, 2022
ENCORE-1 - February 25, 2020
GS-934 - December 28, 2022
ROCKET I - January 23, 2020
SUPPORT - February 24, 2020
THRIVE - December 18, 2022