Open-label, randomised clinical trial to compare the virological efficacy and safety of Atazanavir/Ritonavir on a background of Tenofovir and Emtricitabine vs. Nevirapine on same background, in HIV-1-infected patients who have received no previous antiretroviral treatment - ARTE

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 670

Inclusion Criteria

-Signed informed consent in accordance with GCP and local regulatory requirements prior to trial participation -HIV-1- infected males or females >= 18 years of age with positive serology (ELISA) confirmed by Western blot - No previous antiretroviral treatment (of more than 7 days) -Males with CD4+ counts < 400 cells/mm3 and females with CD4+ counts < 250 cells/mm3 -NVP and ATZ/r susceptibility based on HIV-1 genotypic resistance report - Adequate renal function defined as a calculated creatinine clearance (CLCr) >= 50 ml/min according to the Cockcroft-Gault formula -Karnofsky score >= 70 -Acceptable medical history, as assessed by the investigator
Are the trial subjects under 18? no
Number of subjects for this age range: 0
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

-Active drug abuse or chronic alcoholism at the investigator's discretion -Hepatic cirrhosis stage Child-Pugh B or C -Female patients of child-bearing potential who: ? have a positive serum pregnancy test at screening or during the study, ? are breast feeding, ? are planning to become pregnant, ? are not willing to use a barrier method of contraception, or are not willing to use methods of contraception other than ethinyl estradiol containing oral contraceptives -Laboratory parameters > DAIDS grade 2 (triglycerides > DAIDS grade 3, total cholesterol no restriction, -Active hepatitis B or C disease, defined as HBsAg-positive or HCV-RNApositive with AST/ALT > 2.5x ULN ( > DAIDS grade 1) -Hypersensitivity to any ingredients of the test products -Have therapy with nephrotoxic drugs (e.g., aminoglycosides, amphotericin B, vancomycin, cidofovir, foscarnet, cisplatin, pentamidine, tacrolimus, cyclosporine) or potential competitors of renal excretion (e.g., cidofovir, acyclovir, valacyclovir, ganciclovir, valganciclovir, probenecid, high-dose non-steroidal anti-inflammatory drugs (i.e., ibuprofen)) within 3 months prior to study screening or are expected to receive these during the study -Patients who are receiving other concomitant treatments which are not permitted according to protocol -Use of other investigational medications within 30 days before study entry or during the trial -Use of immunomodulatory drugs within 30 days before study entry or during the trial (e.g., interferon, cyclosporin, hydroxyurea, interleukin 2, chronic treatment with prednisone) -Patient with Progressive Multifocal Leukoencephalopathy (PML), Visceral Kaposi's Sarcoma (KS), and/or any lymphoma -Any AIDS defining illness that is unresolved, symptomatic or not stable on treatment for at least 12 weeks at screening visit -Patients who are receiving systemic treatment for malignant disease -Patients who in the opinion of the investigator are not candidates for inclusion in the study

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Related Trials