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

This study is currently recruiting participants.
Verified by Boehringer Ingelheim Pharmaceuticals, November 2008

Sponsored by: 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

MedlinePlus related topics:   AIDS   

Drug Information available for:   Ritonavir    Nevirapine    Atazanavir sulfate    BMS 232632    Tenofovir    Tenofovir disoproxil    Tenofovir Disoproxil Fumarate    Truvada   

U.S. FDA Resources

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

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:   150
Study Start Date:   September 2007
Estimated Primary Completion Date:   December 2009 (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:

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

Contacts
Contact: Boehringer Ingelheim Study Coordinator     clintriage.rdg@boehringer-ingelheim.com    

Locations
United States, California
1100.1512.20 Boehringer Ingelheim Investigational Site     Recruiting
      Los Angeles, California, United States
1100.1512.28 Boehringer Ingelheim Investigational Site     Recruiting
      Beverly Hills, California, United States
United States, Colorado
1100.1512.15 Boehringer Ingelheim Investigational Site     Recruiting
      Denver, Colorado, United States
United States, District of Columbia
1100.1512.26 Boehringer Ingelheim Investigational Site     Recruiting
      Washington, District of Columbia, United States
United States, Florida
1100.1512.12 Boehringer Ingelheim Investigational Site     Recruiting
      Jacksonville, Florida, United States
1100.1512.14 Boehringer Ingelheim Investigational Site     Recruiting
      Orlando, Florida, United States
1100.1512.17 Boehringer Ingelheim Investigational Site     Recruiting
      Fort LauderDale, Florida, United States
1100.1512.23 Boehringer Ingelheim Investigational Site     Recruiting
      Vero Beach, Florida, United States
United States, New Jersey
1100.1512.11 Boehringer Ingelheim Investigational Site     Recruiting
      Neptune, New Jersey, United States
1100.1512.18 Boehringer Ingelheim Investigational Site     Recruiting
      Somers Point, New Jersey, United States
1100.1512.25 Boehringer Ingelheim Investigational Site     Recruiting
      Newark, New Jersey, United States
United States, North Carolina
1100.1512.22 Boehringer Ingelheim Investigational Site     Recruiting
      Winston-Salem, North Carolina, United States
United States, Pennsylvania
1100.1512.21 Boehringer Ingelheim Investigational Site     Recruiting
      Philadelphia, Pennsylvania, United States
United States, South Carolina
1100.1512.13 Boehringer Ingelheim Investigational Site     Recruiting
      Charleston, South Carolina, United States
United States, Texas
1100.1512.16 Boehringer Ingelheim Investigational Site     Recruiting
      Houston, Texas, United States
1100.1512.19 Boehringer Ingelheim Investigational Site     Recruiting
      Fort Worth, Texas, United States
1100.1512.24 Boehringer Ingelheim Investigational Site     Recruiting
      Houston, Texas, United States
United States, Virginia
1100.1512.27 Boehringer Ingelheim Investigational Site     Recruiting
      Annandale, Virginia, United States

Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals

Investigators
Study Chair:     Boehringer Ingelheim     Boehringer Ingelheim Pharmaceuticals    
  More Information


Responsible Party:   Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair )
Study ID Numbers:   1100.1512
First Received:   September 28, 2007
Last Updated:   November 13, 2008
ClinicalTrials.gov Identifier:   NCT00552240
Health Authority:   United States: Food and Drug Administration

Study placed in the following topic categories:
Sexually Transmitted Diseases, Viral
Acquired Immunodeficiency Syndrome
Atazanavir
Immunologic Deficiency Syndromes
Virus Diseases
Nevirapine
Emtricitabine
HIV Infections
Ritonavir
Sexually Transmitted Diseases
Tenofovir
Retroviridae Infections
Tenofovir disoproxil

Additional relevant MeSH terms:
Anti-Infective Agents
HIV Protease Inhibitors
RNA Virus Infections
Slow Virus Diseases
Anti-HIV Agents
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Enzyme Inhibitors
Infection
Antiviral Agents
Pharmacologic Actions
Protease Inhibitors
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on December 03, 2008




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