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This is a 48-week study to evaluate the safety and efficacy of a new tablet formulation containing two FDA-approved drugs in HIV-infected patients who have not received prior therapy. This tablet will be taken with one of two FDA-approved drugs as a once-daily regimen. Study physicians will evaluate subjects to determine if they have certain medical conditions, laboratory test values, medication use, or drug allergies that would exclude them from the study.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| efavirenz | Drug | |||
| tenofovir | Drug | |||
| abacavir/lamivudine | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Viral load response at 48 weeks | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability Viral load response at 24 weeks Change in T-cell count Resistance Pharmacokinetics | 48 weeks |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials, MD | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Phoenix | Arizona | 85006 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19032103 | Derived | Underwood MR, Ross LL, Irlbeck DM, Gerondelis P, Rouse E, St Clair MH, Trinh L, Parkin N, Lanier E. Sensitivity of phenotypic susceptibility analyses for nonthymidine nucleoside analogues conferred by K65R or M184V in mixtures with wild-type HIV-1. J Infect Dis. 2009 Jan 1;199(1):84-8. doi: 10.1086/595296. |
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| Fountain Valley |
| California |
| 92708 |
| United States |
| GSK Investigational Site | Los Angeles | California | 90033 | United States |
| GSK Investigational Site | San Francisco | California | 94115-1931 | United States |
| GSK Investigational Site | Denver | Colorado | 80205 | United States |
| GSK Investigational Site | Denver | Colorado | 80220 | United States |
| GSK Investigational Site | Fort Collins | Colorado | 80528 | United States |
| GSK Investigational Site | Washington D.C. | District of Columbia | 20007-2113 | United States |
| GSK Investigational Site | Washington D.C. | District of Columbia | 20009 | United States |
| GSK Investigational Site | Washington D.C. | District of Columbia | 20036 | United States |
| GSK Investigational Site | Fort Lauderdale | Florida | 33145 | United States |
| GSK Investigational Site | Fort Lauderdale | Florida | 33308 | United States |
| GSK Investigational Site | Fort Lauderdale | Florida | 33316 | United States |
| GSK Investigational Site | Fort Myers | Florida | 33901 | United States |
| GSK Investigational Site | Jacksonville | Florida | 32206 | United States |
| GSK Investigational Site | Miami | Florida | 33133 | United States |
| GSK Investigational Site | Miami | Florida | 33136 | United States |
| GSK Investigational Site | North Miami | Florida | 33161 | United States |
| GSK Investigational Site | Orlando | Florida | 32804 | United States |
| GSK Investigational Site | Orlando | Florida | 32806 | United States |
| GSK Investigational Site | Tampa | Florida | 33602 | United States |
| GSK Investigational Site | Vero Beach | Florida | 32960 | United States |
| GSK Investigational Site | Atlanta | Georgia | 30309 | United States |
| GSK Investigational Site | Atlanta | Georgia | 30339 | United States |
| GSK Investigational Site | Decatur | Georgia | 30033 | United States |
| GSK Investigational Site | Chicago | Illinois | 60657 | United States |
| GSK Investigational Site | Indianapolis | Indiana | 46202 - 5124 | United States |
| GSK Investigational Site | Wichita | Kansas | 67214 | United States |
| GSK Investigational Site | New Orleans | Louisiana | 70115 | United States |
| GSK Investigational Site | New Orleans | Louisiana | 70127-0800 | United States |
| GSK Investigational Site | Minneapolis | Minnesota | 55404 | United States |
| GSK Investigational Site | Hillsborough | New Jersey | 08844 | United States |
| GSK Investigational Site | Albuquerque | New Mexico | 87131-0001 | United States |
| GSK Investigational Site | Albany | New York | 12208 | United States |
| GSK Investigational Site | Buffalo | New York | 14215 | United States |
| GSK Investigational Site | New York | New York | 10011 | United States |
| GSK Investigational Site | New York | New York | 10014 | United States |
| GSK Investigational Site | Stony Brook | New York | 11794 | United States |
| GSK Investigational Site | Charlotte | North Carolina | 28209 | United States |
| GSK Investigational Site | Cincinnati | Ohio | 45267-0405 | United States |
| GSK Investigational Site | Portland | Oregon | 97210 | United States |
| GSK Investigational Site | Portland | Oregon | 97219 | United States |
| GSK Investigational Site | Hershey | Pennsylvania | 17033 | United States |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19102 | United States |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19107 | United States |
| GSK Investigational Site | Reading | Pennsylvania | 19601 | United States |
| GSK Investigational Site | Providence | Rhode Island | 02903 | United States |
| GSK Investigational Site | Columbia | South Carolina | 29206-4713 | United States |
| GSK Investigational Site | Dallas | Texas | 75208 | United States |
| GSK Investigational Site | Dallas | Texas | 75246 | United States |
| GSK Investigational Site | Fort Worth | Texas | 76104 | United States |
| GSK Investigational Site | Houston | Texas | 77030 | United States |
| GSK Investigational Site | Tyler | Texas | 75708 | United States |
| GSK Investigational Site | Hampton | Virginia | 23666 | United States |
| GSK Investigational Site | Lynchburg | Virginia | 24501 | United States |
| GSK Investigational Site | Seattle | Washington | 98104 | United States |
| GSK Investigational Site | Tacoma | Washington | 98405 | United States |
| GSK Investigational Site | Green Bay | Wisconsin | 54301 | United States |
| 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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| ID | Term |
|---|---|
| C098320 | efavirenz |
| D000068698 | Tenofovir |
| C492871 | abacavir, lamivudine drug combination |
| ID | Term |
|---|---|
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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