Pilot study for the evaluation of the safety and the feasibility of treatment simplification to atazanavir/ritonavir + lamivudine in patients on stable treatment with two NRTIs + atazanavir/ritonavir with optimal virologic response (AtLaS). - ND

POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI0 个研究点开始时间: 2009年4月1日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•Patients treated with a stable regimen including 2NRTIs + ATV/r for at least 6 months
•Aged 18 years or older
•With at least two HIV-RNA levels <50 copies/mL on two consecutive determinations at least 3 months apart
•With CD4 cell count >200 cells/ μL for at least 6 months and absence of any opportunistic infection or AIDS-related disease during the last year before screening.
•Who gave informed consent to the participation to the study
•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

•Pregnancy or breast feeding, desire of pregnancy in the short term
•Previous virological failure to antiretroviral therapy and/or previous exposure to mono- or dual therapies with reverse transcriptase nucleoside analogues.
•Previous major toxicity to any of the study drugs
•Patients with insufficient atazanavir plasma concentration (lower than 0.23 μg/mL at 12 2 hours or 0.15 μg/mL at 24 2 hours post-dosing) at screening
•Patients with grade 3 or 4 laboratory abnormalities at screening (except for lipid levels)
•Concomitant treatment with antacids or proton-pump blockers or any other drug with known interactions or contraindications with the study medications (as per product information)
•Detection of HBsAg in plasma

发起方

POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI