- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00544128
Comparison of Epzicom and Truvada for the Initial Once Daily HIV Treatment
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)
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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;
- The immunologic effects from baseline at the 48th and 144th week
- Reasons of treatment failure by 144th week
- Adverse events and their rate of incidence by 144th week
- Serum concentration of tenofovir in selected patients
- Serum concentration of atazanavir in selected patients
- Renal complication in tenofovir arm
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 4
Kontakter och platser
Studieorter
-
-
Tokyo
-
Shinjuku, Tokyo, Japan, 1628655
- International Medical Center of Japan
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Clinical diagnosis of HIV infection,
- Antiretroviral initiation is recommended by current clinical guidelines,
- Treatment naïve,
- Age over 20 years old Japanese,
- Able to obtain written informed consent
Exclusion Criteria:
- Current malabsorption condition,
- Prior use of lamivudine for hepatitis B treatment,
- Positive serology of Hepatitis B surface antigen,
Patients who have following abnormal laboratory results within 6 weeks prior enrollment;
- alanine aminotransferase is more than 2.5 times higher of upper normal limit
- estimated glomerular filtration rate is less than 60ml/min by Cockcroft-Gault equation
- serum phosphate level is less than 2.0mg/dl
- Patients with hemophilia, diabetes mellitus which require pharmacological treatment, congestive heart failure, cardiomyopathy or other serious medical condition
- Patients in pregnancy or breat feeding
- Patients who are taking medications contraindicated combine use of study medicine
- Patients whose primary care physicians consider inadequate to be enroll the study
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: Epzicom Arm
Patients are treated with Epzicom (lamivudine 300mg and abacavir 600mg) combined with ritonavir 100mg boosted atazanavir 300mg
|
Patients are treated with Epzicom (lamivudine 300mg and abacavir 600mg) combined with ritonavir 100mg boosted atazanavir 300mg
|
Aktiv komparator: Truvada Arm
Patients are treated with Truvada (emtricitabine 200mg and tenofovir 300mg) combined with ritonavir 100mg boosted atazanavir 300mg
|
Patients are treated with Truvada (emtricitabine 200mg and tenofovir 300mg) combined with ritonavir 100mg boosted atazanavir 300mg.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
antiretroviral effect over 48 weeks
Tidsram: 48 weeks
|
48 weeks
|
Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
The immunologic effects from baseline at the 48th and 144th week
Tidsram: 144 weeks
|
144 weeks
|
Reasons of treatment failure by 144th week
Tidsram: 144 weeks
|
144 weeks
|
Adverse events and their rate of incidence by 144th week
Tidsram: 144 weeks
|
144 weeks
|
Samarbetspartners och utredare
Samarbetspartners
Utredare
- Studiestol: Shinichi Oka, MD, International Medical Center of Japan
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Infektioner
- Molekylära mekanismer för farmakologisk verkan
- Anti-infektionsmedel
- Antivirala medel
- Omvända transkriptashämmare
- Nukleinsyrasynteshämmare
- Enzyminhibitorer
- Anti-HIV-medel
- Antiretrovirala medel
- Proteashämmare
- Cytokrom P-450 CYP3A-hämmare
- Cytokrom P-450 enzymhämmare
- HIV-proteashämmare
- Virala proteashämmare
- Tenofovir
- Emtricitabin
- Ritonavir
- Lamivudin
- Atazanavirsulfat
- Abacavir
Andra studie-ID-nummer
- IMCJ-H19-466
- ET001
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