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| 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 |
| Study Type: | Interventional |
| Study Design: | Treatment, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Comparison ATV/r vs NVP Bid on Truvada Backbone |
| 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 |
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:
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
Contacts and Locations| Contact: Boehringer Ingelheim Study Coordinator | clintriage.rdg@boehringer-ingelheim.com |
| 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 | |||||
| Boehringer Ingelheim Pharmaceuticals |
| 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 |
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