|
|
![]() |
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
|||||||||||||||||||||||||||||||||||||||||||||
| Sponsored by: |
Bristol-Myers Squibb |
| Information provided by: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT00067782 |
Purpose
The purpose of this clinical research study is to learn if atazanavir is associated with serum LDL cholesterol in HIV-infected subjects following a substitution of atazanavir for their previously administered protease inhibitor.
| Condition | Intervention | Phase |
|
HIV Infections |
Drug: Atazanavir (immediate switch) Drug: Atazanavir (Week 24 switch) |
Phase III |
| MedlinePlus related topics: | AIDS Cholesterol |
| Drug Information available for: | Atazanavir sulfate BMS 232632 Lipids |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Parallel Assignment |
| Study Start Date: | December 2002 |
| Arms | Assigned Interventions |
| 1: Active Comparator |
Drug: Atazanavir (immediate switch)
Capsules, Oral, 400mg, Once daily, 48 weeks.
|
| 2: Active Comparator |
Drug: Atazanavir (Week 24 switch)
Capsules, Oral, 400mg, Once daily, 48 weeks.
|
Eligibility
| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Key Inclusion Criteria:
Key Exclusion Criteria:
Any of the following:
i) pause length > 3 seconds ii) second or third degree AV heart block iii) QTc interval > 450 msec for males iv) QTc interval > 470 msec for females
Any of the following lab values within 2 weeks of starting study drug:
Contacts and Locations| United States, Arizona | |||||
| Local Institution | |||||
| Phoenix, Arizona, United States | |||||
| United States, California | |||||
| Local Institution | |||||
| West Hollywood, California, United States | |||||
| United States, District of Columbia | |||||
| Local Institution | |||||
| Washington, District of Columbia, United States | |||||
| United States, Florida | |||||
| Local Institution | |||||
| Ft. Lauderdale, Florida, United States | |||||
| Local Institution | |||||
| Tampa, Florida, United States | |||||
| Local Institution | |||||
| Miami, Florida, United States | |||||
| Local Institution | |||||
| Altamonte Springs, Florida, United States | |||||
| United States, Massachusetts | |||||
| Local Institution | |||||
| Boston, Massachusetts, United States | |||||
| United States, Minnesota | |||||
| Local Institution | |||||
| Minneapolis, Minnesota, United States | |||||
| United States, Missouri | |||||
| Local Institution | |||||
| St. Louis, Missouri, United States | |||||
| United States, New Jersey | |||||
| Local Institution | |||||
| East Orange, New Jersey, United States | |||||
| United States, New York | |||||
| Local Institution | |||||
| New York, New York, United States | |||||
| United States, North Carolina | |||||
| Local Institution | |||||
| Huntersville, North Carolina, United States | |||||
| United States, Ohio | |||||
| Local Institution | |||||
| Cleveland, Ohio, United States | |||||
| United States, Oklahoma | |||||
| Local Institution | |||||
| Oklahoma City, Oklahoma, United States | |||||
| United States, Pennsylvania | |||||
| Local Institution | |||||
| Philadelphia, Pennsylvania, United States | |||||
| United States, South Carolina | |||||
| Local Institution | |||||
| Columbia, South Carolina, United States | |||||
| United States, Texas | |||||
| Local Institution | |||||
| Houston, Texas, United States | |||||
| Local Institution | |||||
| Fort Worth, Texas, United States | |||||
| Bristol-Myers Squibb |
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
More Information
BMS Clinical Trials Disclosure 
  |
For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm 
  |
| Study ID Numbers: | AI424-067 |
| First Received: | August 27, 2003 |
| Last Updated: | June 27, 2008 |
| ClinicalTrials.gov Identifier: | NCT00067782 |
| Health Authority: | United States: Food and Drug Administration |
|
|
|
|
|