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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
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To compare the effectiveness (efficacy, safety & tolerability) of a Single Tablet Regimen of efavirenz/emtricitabine/tenofovir DF to subjects continuing on unmodified HAART as measured by the proportion of patients who maintain viral load (HIV-1 RNA) <200 copies/mL at Week 48.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Efavirenz (EFV), Emtricitabine (FTC), Tenofovir DF (TDF) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Primary: Proportion of patients with HIV-1 RNA levels <200 copies/mL at Week 48 | ||
| Safety Outcome Measures: Adverse Events, Laboratory Tests | ||
| Outcomes Research Measures: Quality of life, adherence, preference of medication, perceived ease of regimen, HIV symptoms |
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Inclusion Criteria:
HIV-1 positive patients who have maintained an HIV-1 viral load <200 copies/mL, for at least 3 months.
Patients must be on their first HAART or have documented viral suppression on a PI-based regimen at the time of any prior change in therapy.
HAART must consist of either:
Negative serum pregnancy test.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Flaherty | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hobson City | Alabama | 36201 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20156091 | Derived | Hodder SL, Mounzer K, Dejesus E, Ebrahimi R, Grimm K, Esker S, Ecker J, Farajallah A, Flaherty JF; AI266073 Study Group. Patient-reported outcomes in virologically suppressed, HIV-1-Infected subjects after switching to a simplified, single-tablet regimen of efavirenz, emtricitabine, and tenofovir DF. AIDS Patient Care STDS. 2010 Feb;24(2):87-96. doi: 10.1089/apc.2009.0259. | |
| 19357529 |
| Label | URL |
|---|---|
| ATRIPLA website | View source |
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| Phoenix |
| Arizona |
| 85006 |
| United States |
| Beverly Hills | California | 90211 | United States |
| Long Beach | California | 90813 | United States |
| Los Angeles | California | 90069 | United States |
| Oakland | California | 94609 | United States |
| San Diego | California | 92103 | United States |
| San Francisco | California | 94114 | United States |
| Tarzana | California | 91356 | United States |
| Denver | Colorado | 80220 | United States |
| Norwalk | Connecticut | 06851 | United States |
| Washington D.C. | District of Columbia | 20037 | United States |
| Fort Lauderdale | Florida | 33308 | United States |
| Hollywood | Florida | 33020 | United States |
| Miami | Florida | 33136 | United States |
| Orlando | Florida | 32803 | United States |
| Pensacola | Florida | 32504 | United States |
| Port Saint Lucie | Florida | 34952 | United States |
| Safety Harbor | Florida | 34695 | United States |
| Tampa | Florida | 33607 | United States |
| Vero Beach | Florida | 32960 | United States |
| Atlanta | Georgia | 30312 | United States |
| Decatur | Georgia | 30033 | United States |
| Aurora | Illinois | 60505 | United States |
| Chicago | Illinois | 60657 | United States |
| Indianapolis | Indiana | 46280 | United States |
| Baltimore | Maryland | 21201 | United States |
| Boston | Massachusetts | 02030 | United States |
| Springfield | Massachusetts | 01107 | United States |
| Berkley | Michigan | 48072 | United States |
| Grosse Pointe Woods | Michigan | 48236 | United States |
| Minneapolis | Minnesota | 55404 | United States |
| St Louis | Missouri | 63139 | United States |
| Hillsborough | New Jersey | 08844 | United States |
| Newark | New Jersey | 07101 | United States |
| Newark | New Jersey | 07102 | United States |
| Somers Point | New Jersey | 08244 | United States |
| Albany | New York | 12208 | United States |
| Brooklyn | New York | 11203 | United States |
| Mount Vernon | New York | 10550 | United States |
| New York | New York | 10011 | United States |
| Rochester | New York | 14604 | United States |
| Charlotte | North Carolina | 28209 | United States |
| Greenville | North Carolina | 27858 | United States |
| Winston-Salem | North Carolina | 27157 | United States |
| Akron | Ohio | 44304 | United States |
| Philadelphia | Pennsylvania | 19107 | United States |
| Providence | Rhode Island | 02906 | United States |
| Dallas | Texas | 75204 | United States |
| Harlingen | Texas | 78550 | United States |
| Houston | Texas | 77009 | United States |
| Annandale | Virginia | 22003 | United States |
| Hampton | Virginia | 23666 | United States |
| Spokane | Washington | 99204 | United States |
| Ponce | 00731 | Puerto Rico |
| San Juan | 00909 | Puerto Rico |
| Derived |
| Dejesus E, Young B, Morales-Ramirez JO, Sloan L, Ward DJ, Flaherty JF, Ebrahimi R, Maa JF, Reilly K, Ecker J, McColl D, Seekins D, Farajallah A; AI266073 Study Group. Simplification of antiretroviral therapy to a single-tablet regimen consisting of efavirenz, emtricitabine, and tenofovir disoproxil fumarate versus unmodified antiretroviral therapy in virologically suppressed HIV-1-infected patients. J Acquir Immune Defic Syndr. 2009 Jun 1;51(2):163-74. doi: 10.1097/QAI.0b013e3181a572cf. |
| Gilead Sciences website | View source |
| Bristol-Myers Squibb website | View source |
| 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 |
|---|---|
| C098320 | efavirenz |
| D000068679 | Emtricitabine |
| C075889 | Racivir |
| D000068698 | Tenofovir |
| ID | Term |
|---|---|
| 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 |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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