HIV -immunodefic syndrome- MedDRA version: 9.1 Level: LLT Classification code 10000565 Term: Acquired immunodeficiency syndrome
Conditions
Interventions
Trade Name: TRUVADA
Pharmaceutical Form: Tablet
INN or Proposed INN: EMTRICITABINA/TENOFOVIR DISOPROXIL
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
Trade
Sponsors
AZIENDA OSPEDALIERA SPEDALI CIVILI DI BRESCIA
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 o Aminoglycosides o Cidofovir o Foscarnet o Anfotericine B e.v. o Pentamidine e.v. o Vancomicine e.v. o Ganciclovir o Interleukine 2
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Italy
Outcome results
None listed