Cost-effectiveness of different antiretroviral treatment in patients HIV naive. Randomized clinical, not masked, trial comparing DRVr3TC, ABC3TC (Kivexa) RPV, or EVG COBI FTC TDF (Stribild) for 48 weeks - COST-EFFECT-CLINIC

Fundació Clínic per a la Recerca Biomèdica0 个研究点开始时间: 2015年3月27日最近更新: 2017年8月21日

试验速览

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•1 adults (?18 years)
•2 negative pregnancy test in women of childbearing age, and commitment to use of acceptable methods of contraception since at least 2 weeks prior to day 1 and even as at least 6 months after the last dose of the drug in the study.
•3. stable HIV-1 infection clinically and who have not received prior antiretroviral therapy
•4 to submit viral load HIV 100,000 copiasmL
•5 have numbers of CD4 100 mm3
•6 70mlmin Glomerular filtration
•7 have a negative HLA B5701
•8. patients should have given their informed written consent
•9. in the opinion of the investigator, be able to follow the design of the Protocol visits.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 150
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. Patients who have had prior virologic failure with any guideline antiretroviral
•2 evidence of prior mutations against some of the study drugs
•3. use of any other chronic anti-retroviral treatment has been introduced in the 6 months prior to the entry of the patient in the study
•4. any contraindication to the drug study
•5. any condition that does not allow to ensure the correct adherence to the study at the discretion of the doctor patient
•6. uncontrolled pre-existing psychiatric illness
•7. any current sign of active addiction or alcoholism

发起方

Fundació Clínic per a la Recerca Biomèdica