Nevirapine vs. Atazanavir Boosted With Ritonavir on a Background of Truvada in Human Immunodeficiency Virus (HIV) Infected Naive Patients (NEwArT)

Completed · Phase 4

Conditions studied: HIV Infections

In brief

The aim of this clinical trial is to compare the efficacy and safety of ritonavir (RTV)-boosted atazanavir with nevirapine, each on a background of emtricitabine and tenofovir disoproxil fumarate (DF).

Key facts

Study ID

NCT00552240

Run by

Boehringer Ingelheim

People needed

154

Starts

2007-09-01

Last updated by the study team

2014-01-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed informed consent in accordance with Good Clinical Practice (GCP) and local regulatory requirements prior to trial participation
• HIV-1- infected males or females greater than or equal to 18 years of age with documented positive serology Enzyme-linked Immuno Sorbert Assay (ELISA) confirmed by Western blot
• No prior nucleoside reverse transcriptase inhibitor (NRTI) or non-nucleoside reverse transcriptase inhibitor (NNRTI) use of more than 10 days AND
• No prior use of other classes of antiretrovirals (ARVs) of more than 2 weeks duration
• Males with CD4+ count less than 400 cells/mm cubed or females with CD4+ count less than 250 cells/mm cubed
• NVP and ATV/r susceptibility on screening HIV-1 genotypic resistance assay
• Adequate renal function defined as a calculated creatinine clearance greater than or equal to50 ml/min according to the Cockcroft-Gault formula
• Karnofsky score greater than or equal to 70 (see Appendix 10.7)
• Acceptable medical history, as assessed by the investigator

You may not qualify if…

• History of active drug or alcohol abuse within 2 years prior to study entry (at the investigators discretion)
• Hepatic cirrhosis with stage Child-Pugh B or C hepatic impairment
• Female patients of child-bearing potential who:
• have a positive serum pregnancy test at screening, 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 greater than Division of Aids (National Institute of Health, USA) (DAIDS) grade 2 (triglycerides greater than DAIDS grade 3, total cholesterol no restrictions, see Appendix 10.1)
• Active hepatitis B or C disease, defined as HBsAg-positive or Hepatitis C Virus (HCV) RNA positive with alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ALT/AST greater than2.5x Upper Limit of Normal (ULN) (greater than DAIDS grade 1)
• Known hypersensitivity to any ingredients in nevirapine or atazanavir
• Patients who are receiving concomitant treatments which are not permitted, as listed in Appendix 10.6
• 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)
• Patients 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 the screening visit
• Patients who are receiving systemic chemotherapy

Where it is running

• 1100.1512.28 Boehringer Ingelheim Investigational Site — Beverly Hills, California, United States
• 1100.1512.20 Boehringer Ingelheim Investigational Site — Los Angeles, California, United States
• 1100.1512.15 Boehringer Ingelheim Investigational Site — Denver, Colorado, United States
• 1100.1512.26 Boehringer Ingelheim Investigational Site — Washington D.C., District of Columbia, United States
• 1100.1512.17 Boehringer Ingelheim Investigational Site — Fort Lauderdale, Florida, United States
• 1100.1512.14 Boehringer Ingelheim Investigational Site — Orlando, Florida, United States
• 1100.1512.23 Boehringer Ingelheim Investigational Site — Vero Beach, Florida, United States
• 1100.1512.29 Boehringer Ingelheim Investigational Site — Maywood, Illinois, United States
• 1100.1512.11 Boehringer Ingelheim Investigational Site — Neptune City, New Jersey, United States
• 1100.1512.25 Boehringer Ingelheim Investigational Site — Newark, New Jersey, United States
• 1100.1512.18 Boehringer Ingelheim Investigational Site — Somers Point, New Jersey, United States
• 1100.1512.22 Boehringer Ingelheim Investigational Site — Winston-Salem, North Carolina, United States
• 1100.1512.21 Boehringer Ingelheim Investigational Site — Philadelphia, Pennsylvania, United States
• 1100.1512.13 Boehringer Ingelheim Investigational Site — Charleston, South Carolina, United States
• 1100.1512.30 Boehringer Ingelheim Investigational Site — Dallas, Texas, United States
• 1100.1512.19 Boehringer Ingelheim Investigational Site — Fort Worth, Texas, United States
• 1100.1512.16 Boehringer Ingelheim Investigational Site — Houston, Texas, United States
• 1100.1512.24 Boehringer Ingelheim Investigational Site — Houston, Texas, United States
• 1100.1512.27 Boehringer Ingelheim Investigational Site — Annandale, Virginia, United States

Full record on ClinicalTrials.gov

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