Intracellular concentration of Antiretrovirals)INCA STADY - INCA

Conditions: HIV -immunodefic syndrome-
MedDRA version: 9.1Level: LLTClassification code 10000565Term: Acquired immunodeficiency syndrome

Registration Number: EUCTR2007-007934-21-IT

Lead Sponsor: AZIENDA OSPEDALIERA SPEDALI CIVILI DI BRESCIA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

HIV infected subjects aged 18 years or older
naïve to antiretroviral therapy (any)
creatinine clearance>50 ml/min
platelet count >50000/mmc
total neutrophils >750 cell/mmc
hemoglobin >8 g/dl
AST and ALT <2.5 x upper limit of normality
total bilirubin < 1.5 mg/d
Signed and dated written informed consent
Patients should guarantee that they will not undergone pregnancy or prevent to be pregnant
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

Exclusion Criteria

pregnant women or women who are breastfeeding
alcohol or drug abuse or any condition which might compromise the adherence of the patients to the treatment
Urine Protein >300 mg/24 hours
liver cirrhosis
prior treatment with cytotoxic chemiotherapeutic agents and any agents which can induce kidney damage
oAminoglycosides
oCidofovir
oFoscarnet
oAnfotericine B e.v.
oPentamidine e.v.
oVancomicine e.v.
oGanciclovir
oInterleukine 2

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare plasma and intracellular concentration of tenofovir diphosphate when tenofovir disoproxyl fumavate is prescribed in association with atazanavir boosted with ritonavir or efaviren.;Secondary Objective: The secondary objectives are: to correlate these concentrations with kidney alterations possibly observed during treatment (either glomerular or tubular toxicity). Moreover, we aim at describe lipid variation during therapy after efavirez -versus- atazanavir/ritonavir containing regimens.;Primary end point(s): To compare plasma and intracellular concentration of tenofovir diphosphate when tenofovir disoproxyl fumavate is prescribed in association with atazanavir boosted with ritonavir or efaviren.

Secondary Outcome Measures