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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.
Common TitleACTION Industry
Official Title A Phase IV Randomized, Multicenter, Open-Label Study to Compare the Safety, Tolerability and Efficacy of Trizivir (abacavir 300 mg, lamivudine 150 mg, and zidovudine 300 mg) BID vs Combivir (lamivudine 150 mg and zidovudine 300 mg) BID plus atazanavir 400 mg QD in Antiretroviral Naive HIV-1 Infected Subjects over 48 Weeks
Phase Phase IV
ClinicalTrials.gov NCT00082394
Treatments
Abacavir-Lamivudine-Zidovudine
Abacavir-Lamivudine-Zidovudine
Tradename:TrizivirOther Names:ABC-3TC-ZDVClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Categories Treatment-Naive
Funding
IndustryGlaxo Wellcome
References
- Kumar PN, Salvato P, Lamarca A, et al. A randomized, controlled trial of initial anti-retroviral therapy with abacavir/lamivudine/zidovudine twice-daily compared to atazanavir once-daily with lamivudine/zidovudine twice-daily in HIV-infected patients over 48 weeks (ESS100327, the ACTION Study). AIDS Res Ther. 2009;6:3.
Common TitleCNAA3006 Industry
Official Title A Double-Blind, Randomized, Multicenter Trial to Evaluate the Safety and Efficacy of the Combination of Abacavir (1592U89)/Zidovudine (ZDV)/Lamivudine (3TC) Versus the Combination of Zidovudine (ZDV)/Lamivudine (3TC) in HIV-1 Therapy-Experienced Pediatric Patients.
Phase Phase III
ClinicalTrials.gov NCT00002391
Treatments
Abacavir-Lamivudine-Zidovudine
Abacavir-Lamivudine-Zidovudine
Tradename:TrizivirOther Names:ABC-3TC-ZDVClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Categories PediatricsTreatment-ExperiencedDual Therapy
Funding
IndustryGlaxo Wellcome
References
- Sáez-Llorens X, Nelson RP Jr, Emmanuel P, et al. A randomized, double-blind study of triple nucleoside therapy of abacavir, lamivudine, and zidovudine versus lamivudine and zidovudine in previously treated human immunodeficiency virus type 1-infected children. The CNAA3006 Study Team. Pediatrics. 2001;107:E4.
Common TitleCNAAB3005 Industry
Official Title A Phase III Randomized Double-Blind, Multicenter Study to Evaluate the Safety and Efficacy of 3TC/ZDV/Abacavir (1592U89) and 3TC/ZDV/IDV in HIV-1 Infected Antiretroviral Therapy-Naive Subjects.
Phase Phase III
ClinicalTrials.gov NCT00002199
Treatments
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
IndustryGlaxo Wellcome
References
- Staszewski S, Keiser P, Montaner J, et al. Abacavir-lamivudine-zidovudine vs indinavir-lamivudine-zidovudine in antiretroviral-naive HIV-infected adults: A randomized equivalence trial. JAMA. 2001;285:1155-63.
Common TitleESS40002 Industry
Official Title A 96-Week, Randomized, Open-Label, Multicenter Trial to Evaluate the Safety and Tolerability of the Antiretroviral Activity of Stavudine (40 mg BID) Plus Lamivudine (150mg BID) Plus Nelfinavir (1250 mg BID) Versus Abacavir (300 mg BID) Plus Combivir (3TC 150mg/ZDV 300 mg BID) Versus Combivir (3TC 150 mg/ZDV 300 mg BID) Plus Nelfinavir (1250mg BID) in HIV-1 Infected Subjects
Phase Phase IV
ClinicalTrials.gov NCT00005106
Treatments
Nelfinavir
, Nelfinavir
Tradename:ViraceptOther Names:NFVClass:Protease Inhibitors (PI)Abacavir-Lamivudine-Zidovudine
Abacavir-Lamivudine-Zidovudine
Tradename:TrizivirOther Names:ABC-3TC-ZDVClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Categories PharmacologyTreatment-NaiveAdverse Effects
Funding
IndustryGlaxo Wellcome
References
- Kumar PN, Rodriguez-French A, Thompson MA, et al. A prospective, 96-week study of the impact of Trizivir, Combivir/nelfinavir, and lamivudine/stavudine/nelfinavir on lipids, metabolic parameters and efficacy in antiretroviral-naive patients: effect of sex and ethnicity. HIV Med. 2006;7:85-98.
Common TitleFREE Industry
Official Title Free Study: a Randomised, Open Label, Multicentre Strategic Study to Evaluate the Efficacy and Toxicity of an Early Switch From a PI-containing Regimen to Trizivir ® on Guidance of Viral Load in HIV-1 Infected , Antiretroviral naïve Adults
Phase Phase III
ClinicalTrials.gov NCT00405925
Treatments
Abacavir-Lamivudine-Zidovudine
Abacavir-Lamivudine-Zidovudine
Tradename:TrizivirOther Names:ABC-3TC-ZDVClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Categories Treatment-ExperiencedSwitch/Simplification
Funding
IndustryGlaxo Wellcome
References
- Sprenger HG, Langebeek N, Mulder PG, et al. A randomized controlled trial of single-class maintenance therapy with abacavir/lamivudine/zidovudine after standard triple antiretroviral induction therapy: final 96-week results from the FREE study. HIV Med. 2015;16:122-31.
Official Title Lopinavir/Ritonavir/Combivir vs. Abacavir/Zidovudine/Lamivudine for Virologic Efficacy and the Prevention of Mother-to-Child HIV Transmission Among Breastfeeding Women With CD4 Counts Greater Than or Equal to 200 Cells/mm3 in Botswana
Phase Phase II
ClinicalTrials.gov NCT00270296
Treatments
Lopinavir-Ritonavir
, Lopinavir-Ritonavir
Tradename:KaletraOther Names:LPV-RTVClass:Protease Inhibitors (PI)Abacavir-Lamivudine-Zidovudine
Abacavir-Lamivudine-Zidovudine
Tradename:TrizivirOther Names:ABC-3TC-ZDVClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Categories Pregnancy/Women
Funding
Non-IndustryNational Institute of Allergy and Infectious Diseases (NIAID)
References
- Shapiro RL, Hughes MD, Ogwu A, et al. Antiretroviral regimens in pregnancy and breast-feeding in Botswana. N Engl J Med. 2010;362:2282-94.
- Shapiro RL, Kitch D, Ogwu A, et al. HIV transmission and 24-month survival in a randomized trial of HAART to prevent MTCT during pregnancy and breastfeeding in Botswana. AIDS. 2013;27:1911-20.
Common TitleTARGET Industry
Official Title Combivir, Abacavir (1592U89), Amprenavir (141W94) Triple Antiretroviral, Experienced Patient Trial
Phase Phase IV
ClinicalTrials.gov NCT00002217
Treatments
Abacavir-Lamivudine-Zidovudine
Abacavir-Lamivudine-Zidovudine
Tradename:TrizivirOther Names:ABC-3TC-ZDVClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Categories Treatment-Experienced
Funding
IndustryGlaxo Wellcome
References
- Henry K, Wallace RJ, Bellman PC, et al. Twice-daily triple nucleoside intensification treatment with lamivudine-zidovudine plus abacavir sustains suppression of human immunodeficiency virus type 1: results of the TARGET Study. J Infect Dis. 2001;183:571-8.
Clinical Trial Image Decks
ACTG 5095 - February 24, 2020
Mma Bana - July 5, 2017