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The purpose of this study is to demonstrate that virologically controlled HIV-infected individuals can successfully switch from a protease inhibitor (PI)-based regimen to an efavirenz-based regimen while maintaining virologic control, as evaluated by the proportion of subjects who continue to have plasma HIV-1 levels < 50 copies/mL. In addition, a simplified once-daily regimen will improve adherence and quality of life.
Patients randomized to the non Videx enteric coated (ddl EC)+lamivudine (3TC)+efavirenz (EFV) arm would continue their baseline nucleoside reverse transcriptase inhibitors (NRTIs) on study.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Videx EC | Drug | |||
| Epivir | Drug | |||
| Sustiva | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy at week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety, tolerability and efficacy at weeks (wks) 24 and 48; Effect on lipids at wks 24 and 48; Adherence, quality of life changes, treatment satisfaction and preference at wks 12, 24 and 48 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Little Rock | Arkansas | United States | |||
| Local Institution |
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| Beverly Hills |
| California |
| United States |
| Local Institution | Fountain Valley | California | United States |
| Local Institution | Long Beach | California | United States |
| Local Institution | Los Angeles | California | United States |
| Local Institution | San Diego | California | United States |
| Local Institution | San Francisco | California | United States |
| Local Institution | Tarzana | California | United States |
| Local Institution | West Hollywood | California | United States |
| Local Institution | Denver | Colorado | 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 | Daytona Beach | 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 | South Miami | 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 | Boston | Massachusetts | United States |
| Local Institution | Springfield | Massachusetts | United States |
| Local Institution | Kansas City | Missouri | United States |
| Local Institution | St Louis | Missouri | United States |
| Local Institution | East Orange | New Jersey | United States |
| Local Institution | Newark | New Jersey | United States |
| Local Institution | Union | New Jersey | United States |
| Local Institution | Brooklyn | New York | United States |
| Local Institution | Manhasset | New York | United States |
| Local Institution | Mount Vernon | New York | United States |
| Local Institution | New York | New York | United States |
| Local Institution | Stony Brook | New York | United States |
| Local Institution | Valhalla | New York | United States |
| Local Institution | Philadelphia | Pennsylvania | United States |
| Local Institution | Columbia | South Carolina | United States |
| Local Institution | Austin | Texas | United States |
| Local Institution | Dallas | Texas | United States |
| Local Institution | Hampton | Virginia | United States |
| Local Institution | Milwaukee | Wisconsin | United States |
| Local Institution | Ponce | Puerto Rico |
| Local Institution | Rio Piedras | 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 |
|---|---|
| D016049 | Didanosine |
| D019259 | Lamivudine |
| C098320 | efavirenz |
| ID | Term |
|---|---|
| D007288 | Inosine |
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D015224 | Dideoxynucleosides |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
| D016047 | Zalcitabine |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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