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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator |
| |
| 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atazanavir (immediate switch) | Drug | Capsules, Oral, 400mg, Once daily, 48 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to virologic rebound for subjects with HIV RNA < 50 c/mL at baseline; Magnitude/ durability of increases from baseline in absolute CD4 (Time-Averaged Difference) through WK12; Mean % change from baseline in fasting LDL cholesterol at WK12. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
WOCBP who do not use effective barrier contraception for any reason
Women who are pregnant or breast feeding
A life expectancy < 12 months
Presence of a newly diagnosed HIV-related OI or any medical condition requiring acute therapy at the time of enrollment
Cushing's Syndrome
Uncontrolled diabetes mellitus, history of diabetic ketoacidosis or hyperosmolar syndrome
Untreated hypothyroidism or hyperthyroidism
Nephrotic syndrome or significant proteinuria
Obstructive liver disease
Active alcohol or substance abuse
Proven or suspected acute hepatitis in the 30 days prior to study entry
Intractable diarrhea (greater than or equal to 6 loose stools/day for at least 7 consecutive days) within 30 days prior to study start
History of acute or chronic pancreatitis
Inability to swallow capsules
Presence of cardiomyopathy
Known history of prolonged QTc interval
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
Fasting serum triglyceride level > 750 mg/dL
Any of the following lab values within 2 weeks of starting study drug:
Hypersensitivity to any component of the formulation of study drug
Use of any lipid-lowering agent within 4 weeks prior or during study
Use of a PI-containing ARV regimen prior to entry which is comprised of more than one PI
Inclusion of an NNRTI in the PI-containing regimen
Prisoners or subjects involuntary incarcerated for treatment of psychiatric or physical illness
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Phoenix | Arizona | United States | |||
| Local Institution |
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| Atazanavir (Week 24 switch) | Drug | Capsules, Oral, 400mg, Once daily, 48 weeks. |
|
|
| West Hollywood |
| California |
| United States |
| Local Institution | Washington D.C. | District of Columbia | United States |
| Local Institution | Altamonte Springs | Florida | United States |
| Local Institution | Fort Lauderdale | Florida | United States |
| Local Institution | Miami | Florida | United States |
| Local Institution | Tampa | Florida | United States |
| Local Institution | Boston | Massachusetts | United States |
| Local Institution | Minneapolis | Minnesota | United States |
| Local Institution | St Louis | Missouri | United States |
| Local Institution | East Orange | New Jersey | United States |
| Local Institution | New York | New York | United States |
| Local Institution | Huntersville | North Carolina | United States |
| Local Institution | Cleveland | Ohio | United States |
| Local Institution | Oklahoma City | Oklahoma | United States |
| Local Institution | Philadelphia | Pennsylvania | United States |
| Local Institution | Columbia | South Carolina | United States |
| Local Institution | Fort Worth | Texas | United States |
| Local Institution | Houston | Texas | United States |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000069446 | Atazanavir Sulfate |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009842 | Oligopeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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