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 (ARTEN) - ARTE

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 561

Inclusion Criteria

1.Signed informed consent in accordance with GCP and local regulatory requirements prior to trial participation
2.HIV-1-infected males or females = 18 years of age with positive serology (ELISA) confirmed by Western blot
3.No previous antiretroviral treatment (of more than 7 days)
4.Males with CD4+ counts of < 400 cells/mm3 and females with CD4+ counts of < 250 cells/mm3
5.NVP- and ATZ/r susceptibility based on HIV-1 genotypic resistance report
6.Adequate renal function defined as a calculated creatinine clearance (CLCr) = 50 ml/min according to the Cockcroft-Gault formula as follows:
Male: (140 – age in years) x (weight in kg) divided by 72 x (serum creatinine in mg/dl) = CLCr (ml/min). Female: (140 – age in years) x (weight in kg) divided by 72 x (serum creatinine in mg/dl) x 0.85 = CLCr (ml/min).
7.Karnofsky score = 70
8.Acceptable medical history, as assessed by the investigator

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

1.Active drug abuse or chronic alcoholism at the investigator’s discretion
2.Hepatic cirrhosis stage Child-Pugh B or C
3.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
4.Laboratory parameters > DAIDS grade 2 (triglycerides > DAIDS grade 3; total cholesterol no restrictions)
5.Active hepatitis B or C disease, defined as HBsAg-positive or HCV-RNA-positive with AST/ALT > 2.5x ULN (DAIDS grade 1)
6.Hypersensitivity to any ingredients of the test products
7. (TRIAL PROTOCOL AMENDMENT 4)
8.Patients who are receiving other concomitant treatments which are not permitted, as listed in Appendix 10.6 of the protocol
9.Use of other investigational medications within 30 days before study entry or during the trial
10.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)
11.Patient with Progressive Multifocal Leukoencephalopathy (PML), Visceral Kaposi's Sarcoma (KS), and/or any lymphoma
12.Any AIDS defining illness that is unresolved, symptomatic or not stable on treatment for at least 12 weeks at screening visit
13.Patients who are receiving systemic treatment for malignant disease
14.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

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