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The purpose of this study is to demonstrate that virologically controlled HIV-infected individuals can successfully switch from a standard-of-care regimen dosed twice-daily or more frequently to a simpler once-daily (QD) regimen while maintaining virologic control, as evaluated by the proportion of subjects who continue to have plasma HIV-1 levels <50 copies/mL after switching to a QD regimen.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| stavudine extended-release, lamivudine, efavirenz | 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 | Hobson City | Alabama | United States | |||
| Local Institution |
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| Montgomery |
| Alabama |
| United States |
| Local Institution | Phoenix | Arizona | United States |
| Local Institution | Little Rock | Arkansas | United States |
| Local Institution | Los Angeles | California | United States |
| Local Institution | Sacramento | California | United States |
| Local Institution | San Mateo | California | United States |
| Local Institution | Torrance | California | United States |
| Local Institution | Denver | Colorado | United States |
| Local Institution | Norwalk | Connecticut | United States |
| Local Institution | Stratford | Connecticut | United States |
| Local Institution | Washington D.C. | District of Columbia | United States |
| Local Institution | Fort Lauderdale | Florida | United States |
| Local Institution | Miami | Florida | United States |
| Local Institution | Miami Beach | Florida | United States |
| Local Institution | Pensacola | Florida | United States |
| Local Institution | Tampa | Florida | United States |
| Local Institution | Decatur | Georgia | United States |
| Local Institution | Chicago | Illinois | United States |
| Local Institution | Indianapolis | Indiana | United States |
| Local Institution | New Orleans | Louisiana | United States |
| Local Institution | Baltimore | Maryland | United States |
| Local Institution | Boston | Massachusetts | United States |
| Local Institution | Berkley | Michigan | United States |
| Local Institution | Detroit | Michigan | United States |
| Local Institution | St Louis | Missouri | United States |
| Local Institution | Las Vegas | Nevada | United States |
| Local Institution | Hackensack | New Jersey | United States |
| Local Institution | Jersey City | New Jersey | United States |
| Local Institution | Neptune City | New Jersey | United States |
| Local Institution | Somers Point | New Jersey | United States |
| Local Institution | Manhasset | New York | United States |
| Local Institution | New York | New York | United States |
| Local Institution | The Bronx | New York | United States |
| Local Institution | Charlotte | North Carolina | United States |
| Local Institution | Huntersville | North Carolina | United States |
| Local Institution | Washington | North Carolina | United States |
| Local Institution | Winston-Salem | North Carolina | United States |
| Local Institution | Philadelphia | Pennsylvania | United States |
| Local Institution | Reading | Pennsylvania | United States |
| Local Institution | Dallas | Texas | United States |
| Local Institution | Galveston | Texas | United States |
| Local Institution | Houston | Texas | United States |
| Local Institution | Annandale | Virginia | United States |
| Local Institution | Hampton | Virginia | United States |
| Local Institution | Seattle | Washington | United States |
| Local Institution | San Juan | 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 |
|---|---|
| D019259 | Lamivudine |
| C098320 | efavirenz |
| ID | Term |
|---|---|
| D016047 | Zalcitabine |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D015224 | Dideoxynucleosides |
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