|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | 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 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Study Start Date: | December 2002 |
| Study Completion Date: | March 2005 |
| Primary Completion Date: | March 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: 1 |
Drug: Atazanavir (immediate switch)
Capsules, Oral, 400mg, Once daily, 48 weeks.
Other Name: Reyataz
|
| Active Comparator: 2 |
Drug: Atazanavir (Week 24 switch)
Capsules, Oral, 400mg, Once daily, 48 weeks.
Other Name: Reyataz
|
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 | |
| Altamonte Springs, Florida, United States | |
| Local Institution | |
| Ft. Lauderdale, Florida, United States | |
| Local Institution | |
| Miami, Florida, United States | |
| Local Institution | |
| Tampa, 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 | |
| Fort Worth, Texas, United States | |
| Local Institution | |
| Houston, Texas, United States | |
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
More Information
| ClinicalTrials.gov Identifier: | NCT00067782 History of Changes |
| Other Study ID Numbers: | AI424-067 |
| Study First Received: | August 27, 2003 |
| Last Updated: | April 7, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
HIV Treatment Experienced |
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
Atazanavir HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses |