A Phase 4 interventional study of lamivudine, abacavir , ritonavir, atazanavir and emtricitabine, tenofovir, ritonavir, atazanavir in HIV Infections, sponsored by International Medical Center of Japan. Completed at 1 site in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2015-03-30.
Sponsored by International Medical Center of Japan · Phase 4, Interventional, and Treatment
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.
In treatment naïve HIV-1-infected patients, once daily combination antiretroviral therapy containing ritonavir boosted atazanavir combined with Epzicom will offer non inferior antiretroviral efficacy compared to ritonavir boosted atazanavir combined with Truvada. This non inferiority hypothesis is studied by a randomized, open label, multicenter trial over 48 weeks as the primary endpoint and long term safety of both arms are followed for 144 weeks.
The primary endpoint is the antiretroviral effect over 48 weeks.
The secondary endpoints are;
6,688 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 109 is close to the median of 120 across 4,201 interventional studies indexed under Infections.
Browse Infections studies →International Medical Center of Japan is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients who have following abnormal laboratory results within 6 weeks prior enrollment;
Patients are treated with Epzicom (lamivudine 300mg and abacavir 600mg) combined with ritonavir 100mg boosted atazanavir 300mg
Drug: lamivudine, abacavir , ritonavir, atazanavir
Patients are treated with Truvada (emtricitabine 200mg and tenofovir 300mg) combined with ritonavir 100mg boosted atazanavir 300mg
Drug: emtricitabine, tenofovir, ritonavir, atazanavir
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.
antiretroviral effect over 48 weeks
Time frame: 48 weeks
The immunologic effects from baseline at the 48th and 144th week
Time frame: 144 weeks
Reasons of treatment failure by 144th week
Time frame: 144 weeks
Adverse events and their rate of incidence by 144th week
Time frame: 144 weeks
This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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International Medical Center of Japan