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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.
Study NCT00552240   Information provided by Boehringer Ingelheim Pharmaceuticals
First Received: September 28, 2007   Last Updated: November 23, 2009   History of Changes

September 28, 2007
November 23, 2009
September 2007
March 2010   (final data collection date for primary outcome measure)
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 ]
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.
Complete list of historical versions of study NCT00552240 on ClinicalTrials.gov Archive Site
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 ]
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
 
Nevirapine vs. Atazanavir Boosted With Ritonavir on a Background of Truvada in HIV Infected Naive Patients (NEwArT)
Comparison ATV/r vs NVP Bid on Truvada Backbone

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.

 
Phase IV
Interventional
Treatment, Parallel Assignment, Safety/Efficacy Study
HIV Infections
  • Drug: Nevirapine
  • Drug: Atazanavir/ritonavir
  • Drug: Emtricitabine (FTC) and Tenofovir (TDF)
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
155
 
March 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00552240
Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
1100.1512
Boehringer Ingelheim Pharmaceuticals
 
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
Boehringer Ingelheim Pharmaceuticals
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP