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This study will compare the response of subjects who failed a first-line ATV-containing regimen and who have the 150L-containing virus to subsequent protease inhibitor (PI)-containing therapy with that of a cohort who has failed a first-line reverse transcriptase inhibitor (NNRTI), and is subsequently receiving PI-containing therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A1 | HIV infected individuals on first line ATV based HAART with presence of I50L mutation. |
| |
| A2 | HIV infected PI naïve on failed NNRTI based regimen. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LPV/RTV + 2NRTIs | Drug | Tablets, Oral, Variable, Twice daily, 48 weeks. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The log10 HIV RNA change from baseline for each cohort. | through Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate proportion of patients with plasma HIV RNA <50 copies/mL | at Weeks 24, 48, 72, and 96. |
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Inclusion Criteria:
Exclusion Criteria:
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HIV infected individuals on first line ATV based HAART with presence of I50L mutation & HIV infected PI naïve on failed NNRTI based regimen.
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Phoenix | Arizona | United States | |||
| Local Institution |
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| LPV/RTV + 2NRTIs |
| Drug |
Tablets, Oral, Variable, Twice daily, 48 weeks. |
|
| Altamonte Springs |
| Florida |
| United States |
| Local Institution | Fort Lauderdale | Florida | United States |
| Local Institution | Vero Beach | Florida | United States |
| Local Institution | Honolulu | Hawaii | United States |
| Local Instution | Wichita | Kansas | United States |
| Local Instution | Lexington | Kentucky | United States |
| Local Institution | Louisville | Kentucky | United States |
| Local Institution | East Orange | New Jersey | United States |
| Local Institution | Albany | New York | United States |
| Local Institution | Huntersville | North Carolina | United States |
| Local Institution | Portland | Oregon | United States |
| Local Institution | Dallas | Texas | United States |
| Local Institution | Buenos Aires | Buenos Aires | Argentina |
| Local Institution | Capital Federal | Buenos Aires | Argentina |
| Local Institution | La Plata | Buenos Aires | Argentina |
| Local Institution | Mar del Plata | Buenos Aires | Argentina |
| Local Institution | Córdoba | Córdoba Province | Argentina |
| Local Institution | Rosario | Santa Fe Province | Argentina |
| Local Institution | Buenos Aires | Argentina |
| Local Institution | Curitiba | Paraná | Brazil |
| Local Institution | Recife | Pernambuco | Brazil |
| Local Institution | Rio de Janeiro | Rio de Janeiro | Brazil |
| Local Institution | Campinas | São Paulo | Brazil |
| Local Institution | São Paulo | Brazil |
| Local Institution | Guatemala City | Guatemala |
| Local Institution | Durango | Durango | Mexico |
| Local Institution | Guadalajara | Jalisco | Mexico |
| Local Institution | Lima | Lima Province | Peru |
| Local Institution | Port Elizabeth | Eastern Cape | South Africa |
| Local Institution | Bloemfontein | Free State | South Africa |
| Local Institution | Bedford Gardens | Gauteng | South Africa |
| Local Institution | Johannesburg | Gauteng | South Africa |
| Local Institution | Meadowdale | Gauteng | South Africa |
| Local Institution | Westdene | Gauteng | South Africa |
| Local Institution | Mowbray | Western Cape | South Africa |
| Local Institution | Rugby | Western Cape | South Africa |
| 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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