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The purpose of this study is to compare the anti-HIV efficacy, safety and effect of serum lipids of two boosted protease inhibitor-based HAART regimens (ARV/RTV v. LPV/RTV) in HIV-1 infected subjects who have experienced their first virologic failure while receiving a NNRTI-containing HAART regimen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator |
| |
| B | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atazanavir+ritonavir | Drug | Capsules, Oral, 300mg/100mg, once daily, 24 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Co-Primary Outcomes in this study 1)Viral load reduction from baseline through Week 24 2)Change in lipids from baseline at Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Viral load reduction from baseline at Weeks 48,72,96;Subjects with HIV RNA<50 and <400 c/mL at Weeks 24,48,72 & 96;Patterns of resistance;Safety and tolerability through Week 96 including fasting lipid values;Adherence at Weeks 4,12,24,48,72 & 96. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Hobson City | Alabama | United States | |||
| Local Institution |
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| Lopinavir+ritonavir | Drug | Capsules, Oral, 800mg/200mg, twice daily, 24 weeks. |
|
| Montgomery |
| Alabama |
| United States |
| Local Institution | Phoenix | Arizona | United States |
| Local Institution | Little Rock | Arkansas | United States |
| Local Institution | Bakersfield | California | United States |
| Local Institution | Los Angeles | California | United States |
| Local Institution | San Francisco | California | United States |
| Local Institution | San Mateo | California | United States |
| Local Institution | Tarzana | California | United States |
| Local Institution | West Hollywood | California | United States |
| Local Institution | Norwalk | Connecticut | United States |
| Local Institution | Washington D.C. | District of Columbia | United States |
| Local Institution | Atlantis | Florida | United States |
| Local Institution | Fort Lauderdale | Florida | United States |
| Local Institution | Jacksonville | Florida | United States |
| Local Institution | Miami | Florida | United States |
| Local Institution | Miami Beach | Florida | United States |
| Local Institution | North Miami | Florida | United States |
| Local Institution | Orlando | Florida | United States |
| Local Institution | Plantation | Florida | United States |
| Local Institution | Safety Harbor | Florida | United States |
| Local Institution | Tampa | Florida | United States |
| Local Institution | Atlanta | Georgia | United States |
| Local Institution | Decatur | Georgia | United States |
| Local Institution | Chicago | Illinois | United States |
| Local Institution | Indianapolis | Indiana | United States |
| Local Institution | Louisville | Kentucky | United States |
| Local Institution | New Orleans | Louisiana | United States |
| Local Institution | Boston | Massachusetts | United States |
| Local Institution | Springfield | Massachusetts | United States |
| Local Institution | Berkley | Michigan | United States |
| Local Institution | Jackson | Mississippi | United States |
| Local Institution | St Louis | Missouri | United States |
| Local Institution | Las Vegas | Nevada | United States |
| Local Institution | East Orange | New Jersey | United States |
| Local Institution | Hillsborough | New Jersey | United States |
| Local Institution | Jersey City | New Jersey | United States |
| Local Institution | Brooklyn | New York | United States |
| Local Institution | Mount Vernon | New York | United States |
| Local Institution | New York | New York | United States |
| Local Institution | Valhalla | New York | United States |
| Local Institution | Greenville | North Carolina | United States |
| Local Institution | Huntersville | North Carolina | United States |
| Local Institution | Winston-Salem | North Carolina | United States |
| Local Institution | Oklahoma City | Oklahoma | United States |
| Local Institution | Philadelphia | Pennsylvania | United States |
| Local Institution | Columbia | South Carolina | United States |
| Local Institution | Dallas | Texas | United States |
| Local Institution | Galveston | Texas | United States |
| Local Institution | Harlingen | Texas | United States |
| Local Institution | Houston | Texas | United States |
| Local Institution | Hampton | Virginia | United States |
| Local Institution | Santruce | Puerto Rico |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000163 | Acquired Immunodeficiency Syndrome |
| 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 |
| D012897 | Slow Virus Diseases |
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| ID | Term |
|---|---|
| C000718687 | atazanavir, ritonavir drug combination |
| D000069446 | Atazanavir Sulfate |
| D061466 | Lopinavir |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009842 | Oligopeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
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