Pilot study on efficacy of a simplification strategy from DRV/r 600/100 mg BID to DRV/r 800/100mg QD + OBT in HIV-positive patients HAART-experienced with virological response. - DRV-xp

ISTITUTO NAZIONALE DELLE MALATTIE INFETTIVE LAZZARO SPALLANZANI0 个研究点开始时间: 2009年11月2日最近更新: 2014年2月10日

适应症

试验速览

暂无简介。

•->18 years;
•-Confirmed HIV-infection;
•-Being on stable therapy with DRV/r 600/100mg BID + OBT from at least 6 months
•-CD4+ >100 cellule/L at starting HAART and CD4> 200 cell/ml at scrrening.
•-Confirmed HIV-1 RNA <40 cp/mL for at least 3 months while treated with DRV/r 600/100mg BID + OBT;
•-No evidence of DRV-RAMS (resi stance associated mutations) at previous GRT
•-Writen informed consent.
•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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•-Previous virological failure (2 confirmed HIV-1 RNA VL>500 cp/ml) while on DRV/RTV-based therapy.
•-Previous evidence of >3 DRV-RAMS (resistance- associeted mutations) according with IAS-USA guidelines 2008 (V11I, V32I, L33F, I47V, I50V, I84V, I54M/L, T74P, L76V, L89V)
•-Intollerance to the drug used
•Contraindicated concomitant treatment
•-Subjects which in the opinion of the investigator is unable to complete the study period;
•-Laboratory alterations:
•oSGOT and SGPT ≥2,5 UNL;
•ocreatinin >1,5 UNL;
•oANC <1000/mm3;
•oHb <10 g/dL;
•oPLT <75.000/mm3;
•-Clinically significant disease
•-Pregnancy

发起方

ISTITUTO NAZIONALE DELLE MALATTIE INFETTIVE LAZZARO SPALLANZANI