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 sitesApril 1, 2009

Overview

No summary available.

Registry

who.int

Start Date

April 1, 2009

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI

•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/ \&\#956;L 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

•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 \&\#956;g/mL at 12 \&\#61617;2 hours or 0\.15 \&\#956;g/mL at 24 \&\#61617;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