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| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Female patients of child-bearing potential who:
Contacts and 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 | |
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
More Information
| 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 |
|
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 |