A Randomized, Open Label, Multicenter Study Comparing the Safety and Efficacy of Once Daily Regimen Containing Epzicom or Truvada Combined With Ritonavir Boosted Atazanavir as Initial Therapy for HIV-1 Infection (ET Study)
Sponsor study identifier
Secondary identifiers
interventional
109
1 country
1
Study Start
October 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2012
Actual (reported)Study Completion
February 2012
Actual (reported)A non-inferiority randomized control trial in treatment naïve HIV patients to compare virologic effect of two backbone regimens with Epzicom (lamivudine and abacavir) and Truvada (emtricitabine and tenofovir). Both arms are treated with fixed combination of ritonavir boosted atazanavir as key drugs.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2012
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2007
Date type not reportedThis date has not been verified as actual or estimated.
October 12, 2007
Actual (reported)October 16, 2007
Actual (reported)February 2012
Actual (reported)February 2012
Actual (reported)antiretroviral effect over 48 weeks
48 weeks
The immunologic effects from baseline at the 48th and 144th week
144 weeks
Reasons of treatment failure by 144th week
144 weeks
Adverse events and their rate of incidence by 144th week
144 weeks
Patients are treated with Epzicom (lamivudine 300mg and abacavir 600mg) combined with ritonavir 100mg boosted atazanavir 300mg
Patients are treated with Truvada (emtricitabine 200mg and tenofovir 300mg) combined with ritonavir 100mg boosted atazanavir 300mg
Patients are treated with Epzicom (lamivudine 300mg and abacavir 600mg) combined with ritonavir 100mg boosted atazanavir 300mg
Patients are treated with Truvada (emtricitabine 200mg and tenofovir 300mg) combined with ritonavir 100mg boosted atazanavir 300mg.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
lamivudine, abacavir , ritonavir, atazanavir
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordGrouped treatment entry
emtricitabine, tenofovir, ritonavir, atazanavir
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordInternational Medical Center of Japan
Shinjuku, Tokyo, 1628655, Japan
Nishijima T, Takano M, Ishisaka M, Komatsu H, Gatanaga H, Kikuchi Y, Endo T, Horiba M, Kaneda S, Uchiumi H, Koibuchi T, Naito T, Yoshida M, Tachikawa N, Ueda M, Yokomaku Y, Fujii T, Higasa S, Takada K, Yamamoto M, Matsushita S, Tateyama M, Tanabe Y, Mitsuya H, Oka S; Epzicom-Truvada study team. Abacavir/lamivudine versus tenofovir/emtricitabine with atazanavir/ritonavir for treatment-naive Japanese patients with HIV-1 infection: a randomized multicenter trial. Intern Med. 2013;52(7):735-44. doi: 10.2169/internalmedicine.52.9155. Epub 2013 Apr 1.
Shinichi Oka, MD
International Medical Center of Japan
109 participants (actual enrollment reported by the registry).
First Submitted
October 12, 2007
First Posted
October 16, 2007
Study Start
October 2007
Date type not reportedThis date has not been verified as actual or estimated.
Nevirapine vs. Atazanavir Boosted With Ritonavir on a Background of Truvada in Human Immunodeficiency Virus (HIV) Infected Naive Patients (NEwArT)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
February 2012
Actual (reported)Study Completion
February 2012
Actual (reported)Last Updated
March 30, 2015
Record last verified: 2015-03
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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