on-inferiority,randomized clinical trial to evaluate the efficacy and the safety of the use of fixed-dose combination efavirenz/tenofovir/emtricitabine (Atripla) administered in alternate days versus the standard of care in HIV-1 infected patients with sustained virological response during HAART

ISTITUTO NAZIONALE DELLE MALATTIE INFETTIVE LAZZARO SPALLANZANI0 个研究点开始时间: 2011年12月28日最近更新: 2012年9月3日

适应症

试验速览

暂无简介。

•- Age> 18 years; - Treatment with a stable regimen containing efavirenz and tenofovir / emtricitabine for at least 24 weeks before screening; - Nadir CD4 +> 200 cells / mmc and CD4 +> 300 cells / mmc at screening; - Viral load <40cp/ml for at least 6 months at screening (at least 2 determinations should have been detected); - Efavirenz C trough above 1000 ng / mL at screening; -Signature of appropriate informed consent; -Pregnancy test negative on blood screening; -Willingness to use appropriate means of contraception for the duration of the study; -owning the phone
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 200
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•- Patients aged <18 years or> 65 years; - HIV RNA> 40 copies / mL in the 6 months prior to screening; - Previous virological failure or evidence of intermediate / high-level resistance to efavirenz, tenofovir or cytidine analogs; - Co-infection with HBV; - Creatinine clearance <50 mL / min at screening or evidence of renal involute years; - Pregnancy or desire for parenthood; - Opportunistic infections or AIDS defining illnesses in place; - History of any solid or haematological malignancy; - Use of psychoactive substances that may in any way interfere with the patient's adherence to the prescribed treatment regimen; - Persons who, in the opinion of the investigator, does not ensure adequate adherence to the study; - Patients who are receiving or have received antineoplastic or immunomodulatory (IL-2, GMCSF ...) in the last 12 months; - Patients with liver cirrhosis; - Participation in other clinical trials or pharmacological treatment with experimental drugs in the 30 days prior to entry in the protocol; - Allergy to any drugs in the regimen; - Inability to sign informed consent.

发起方

ISTITUTO NAZIONALE DELLE MALATTIE INFETTIVE LAZZARO SPALLANZANI