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Nevirapine vs. Atazanavir Boosted With Ritonavir on a Background of Truvada in HIV Infected Naive Patients (NEwArT)
This study is ongoing, but not recruiting participants.
First Received: September 28, 2007   Last Updated: January 13, 2010   History of Changes
Sponsor: Boehringer Ingelheim Pharmaceuticals
Information provided by: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00552240
  Purpose

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


Condition Intervention Phase
HIV Infections
Drug: Nevirapine
Drug: Atazanavir/ritonavir
Drug: Emtricitabine (FTC) and Tenofovir (TDF)
Phase IV

Study Type: Interventional
Study Design: Treatment, Parallel Assignment, Safety/Efficacy Study
Official Title: Comparison ATV/r vs NVP Bid on Truvada Backbone

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • The primary endpoint is the virologic response (VR) at Week 48. VR is defined as HIV viral load of <50 copies/ml measured at two consecutive visits by Week 48 and without subsequent rebound or change of ARV therapy prior to Week 48. [ Time Frame: 48 weeks ]

Secondary Outcome Measures:
  • Time to virologic response defined as the first of the two consecutive measurements showing VL <50 copies/ml. Proportions of patients with an HIV viral load of <50 and <400 copies/ml at each visit [ Time Frame: 48 weeks ]

Estimated Enrollment: 155
Study Start Date: September 2007
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 greater than or equal to 18 years of age with documented positive serology (ELISA) confirmed by Western blot
  3. No prior NRTI or NNRTI use of more than 10 days AND
  4. No prior use of other classes of ARVs of more than 2 weeks duration
  5. Males with CD4+ count less than 400 cells/mm cubed or females with CD4+ count less than 250 cells/mm cubed
  6. NVP and ATV/r susceptibility on screening HIV-1 genotypic resistance assay
  7. Adequate renal function defined as a calculated creatinine clearance greater than or equal to50 ml/min according to the Cockcroft-Gault formula
  8. Karnofsky score greater than or equal to 70 (see Appendix 10.7)
  9. Acceptable medical history, as assessed by the investigator

Exclusion Criteria:

  1. History of active drug or alcohol abuse within 2 years prior to study entry(at the investigators discretion)
  2. Hepatic cirrhosis with stage Child-Pugh B or C hepatic impairment
  3. 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
  4. Laboratory parameters greater than DAIDS grade 2 (triglycerides greater than DAIDS grade 3, total cholesterol no restrictions, see Appendix 10.1)
  5. Active hepatitis B or C disease, defined as HBsAg-positive or HCV RNA positive with ALT/AST greater than2.5x ULN (greater than DAIDS grade 1)
  6. Known hypersensitivity to any ingredients in nevirapine or atazanavir
  7. Patients who are receiving concomitant treatments which are not permitted, as listed in Appendix 10.6
  8. Use of other investigational medications within 30 days before study entry or during the trial
  9. 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)
  10. Patients with Progressive Multifocal Leukoencephalopathy (PML), visceral Kaposi's Sarcoma (KS), and/or any lymphoma
  11. Any AIDS defining illness that is unresolved, symptomatic or not stable on treatment for at least 12 weeks at the screening visit
  12. Patients who are receiving systemic chemotherapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00552240

Locations
United States, California
1100.1512.20 Boehringer Ingelheim Investigational Site
Los Angeles, California, United States
1100.1512.28 Boehringer Ingelheim Investigational Site
Beverly Hills, California, United States
United States, Colorado
1100.1512.15 Boehringer Ingelheim Investigational Site
Denver, Colorado, United States
United States, District of Columbia
1100.1512.26 Boehringer Ingelheim Investigational Site
Washington, District of Columbia, United States
United States, Florida
1100.1512.14 Boehringer Ingelheim Investigational Site
Orlando, Florida, United States
1100.1512.17 Boehringer Ingelheim Investigational Site
Fort Lauderdale, Florida, United States
1100.1512.23 Boehringer Ingelheim Investigational Site
Vero Beach, Florida, United States
United States, Illinois
1100.1512.29 Boehringer Ingelheim Investigational Site
Maywood, Illinois, United States
United States, New Jersey
1100.1512.11 Boehringer Ingelheim Investigational Site
Neptune, New Jersey, United States
1100.1512.18 Boehringer Ingelheim Investigational Site
Somers Point, New Jersey, United States
1100.1512.25 Boehringer Ingelheim Investigational Site
Newark, New Jersey, United States
United States, North Carolina
1100.1512.22 Boehringer Ingelheim Investigational Site
Winston-Salem, North Carolina, United States
United States, Pennsylvania
1100.1512.21 Boehringer Ingelheim Investigational Site
Philadelphia, Pennsylvania, United States
United States, Texas
1100.1512.16 Boehringer Ingelheim Investigational Site
Houston, Texas, United States
1100.1512.19 Boehringer Ingelheim Investigational Site
Fort Worth, Texas, United States
1100.1512.24 Boehringer Ingelheim Investigational Site
Houston, Texas, United States
1100.1512.30 Boehringer Ingelheim Investigational Site
Dallas, Texas, United States
United States, Virginia
1100.1512.27 Boehringer Ingelheim Investigational Site
Annandale, Virginia, United States
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair )
Study ID Numbers: 1100.1512
Study First Received: September 28, 2007
Last Updated: January 13, 2010
ClinicalTrials.gov Identifier: NCT00552240     History of Changes
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Infection
Reverse Transcriptase Inhibitors
Emtricitabine
Anti-Retroviral Agents
Therapeutic Uses
Retroviridae Infections
Nucleic Acid Synthesis Inhibitors
HIV Protease Inhibitors
RNA Virus Infections
Anti-HIV Agents
Immune System Diseases
Acquired Immunodeficiency Syndrome
Atazanavir
Enzyme Inhibitors
Antiviral Agents
Immunologic Deficiency Syndromes
Pharmacologic Actions
Protease Inhibitors
Virus Diseases
Nevirapine
HIV Infections
Ritonavir
Sexually Transmitted Diseases
Lentivirus Infections

ClinicalTrials.gov processed this record on February 08, 2010