A pilot, randomized trial to evaluate the lipid profile after antiretroviral regimens including nevirapine or atazanavir boosted with ritonavir in HIV-positive patients naive for antiretrovirals - STAR2

Conditions: immunodefic syndrome - patients naive antiretroviral therapy
MedDRA version: 9.1Level: LLTClassification code 10000565Term: Acquired immunodeficiency syndrome

Registration Number: EUCTR2007-007882-19-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
-creatinine Clearance>80 ml/min
-art- naive
-platelet count >50000/mmc
-total neutrophils >750 cell/mmc
-hemoglobin >10g/dlupper normal value
-bilirubin total < 1.5 mg/d
-Signed and dated written informed consente
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

-women with CD4 >250 cell/mmc
-menCD4 >400 cell/mm
- pregnant womaen or women who are breastfeeding
-alcohol or drag abuse or any condition which might compromise the aderence of the patients to the treatment
-Proteinuria >300 mg/24 ore
-liver cirrhosis
-prior treatment with citotoxics chemiotherapeutic agents and any agents which can induce kidney damage

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: This study aimes at comparing the lipid profile after initiating atazanavir/ritonavir versus nevirapine containing regimens.;Secondary Objective: -To compare intracellular and plasma tenofovir concentrations when associated with atazanavir/ritonavir versus nevirapine<br>-To assess whether different tenofovir concentrations may impact on toxicity profile (e.g., nephopathy) differently in the two study arms<br>-To compare viro-immunological effectiveness of the two treatment arms (tenofovir/emtricitabine+nevirapine vs. tenofovir/emtricitabine+atazanavir/ritonavir);Primary end point(s): -ipercolesterolemia (HDL/ LDL) IPERTRIGLICERINEMIA

Secondary Outcome Measures