Strategic study of dual-therapy with darunavir/ritonavir and rilpivirine QD versus triple-therapy in patients with suppressed viral load: virological efficacy and evaluation of non-HIV related morbidity.

AZIENDA OSPEDALIERA L. SACCO (A.O. DI RILIEVO NAZIONALE)0 个研究点开始时间: 2012年12月28日最近更新: 2014年2月3日

试验速览

暂无简介。

•Adult HIV+ subjects (>18 years old), giving and signing an informed consent;
•Any HAART treatment for at least 12 months;
•Current treatment with a PI/r-containing regimen initiated at least 6 months earlier;
•HIV-RNA <50 cp/mL for at least 3 months, without viral blip due to virologic failure at any time;
•Any nadir CD4 lymphocytes;
•Current CD4 count > 100 cell/uL;
•eGFRs >60 mL/min/1,73 m2.
•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 120
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 12

•Previous drug resistance genotypic test showing the presence of any RPV (RT: K101E/P, E138A/G/K/Q/R, V179L, Y181C/I/V, Y188L, H221Y, F227C, M230I/L) or DRV (protease: V11I, V32I, L33F, I47V, I50V, I54M/L, T74P, L76V, I84V, L89V) resistance associated mutation (RAM), according to the November 2011 IAS-USA list;
•Child-Pugh C or grade 3-4 AST or ALT values;
•Acute cardiovascular event within 6 months;
•AIDS event within 6 months;
•Current IVDU;
•HBsAg + ;
•Pregnancy or lactation.

发起方

AZIENDA OSPEDALIERA L. SACCO (A.O. DI RILIEVO NAZIONALE)