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A 48-week study to investigate the safety and effectiveness of a new compact formulation of two already FDA-approved anti-HIV drugs in subjects who have already been receiving treatment for their HIV infection.
A phase III, randomized, open-label, parallel, multicenter study to evaluate treatment with fixed-dose combination of abacavir/lamivudine (600mg/300mg) once-daily versus abacavir (300mg) twice-daily and lamivudine (300mg) once-daily in combination with tenofovir once-daily and a new PI or NNRTI for 48 weeks in ART-experienced HIV-1 infected patients.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| abacavir/lamivudine | Drug | |||
| abacavir | Drug | |||
| lamivudine | Drug | |||
| tenofovir | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| HIV viral load response as measured by change from baseline in HIV-1 RNA over 24 and 48 weeks. Safety | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Viral load response T-cell count Health Outcomes Resistance |
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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 | Los Angeles | California | 90046 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | EFFICACY AND SAFETY OF A ONCE DAILY FIXED-DOSE COMBINATION OF ABACAVIR/LAMIVUDINE (ABC/3TC) [FDC ] VERSUS ABC TWICE DAILY AND 3TC ONCE DAILY AS SEPARATE ENTITIES [SE] IN ART-EXPERIENCED HIV-1 INFECTED SUBJECTS (CAL30001): 48 WEEK DATA. Clumeck, N., LaMarca, A., Fu, K., Gordon, D., Craig, C., Zhao, H. , Paes, D., and Scott, T. (WePe6.3C13), 3rd International AIDS Society Conference on HIV Pathogenesis and Treatment, Rio de Janeiro; Brazil, 7/24/2005 | ||
| Result | C Craig, C Stone, T Bonny, K Fu. Similar virology findings in ABC/3TC fixed dose combination (FDC) OAD compared with standard dosing in experienced subjects (CAL30001, ALTO). 7th ICDTHI, Glasgow, UK, 14-18 November 2004. Abstract 98 | ||
| Result | Clumeck N, Lamarca A, Fu K, Gordon D, Craig C, Zhao H, Paes D, Scott T. Safety and efficacy of a once daily (OAD) Fixed-Dose Combination (FDC) of ABC/3TC [FDC arm] versus ABC twice daily (BID) and 3TC OAD as separate entities [SE arm] in ART-Experienced HIV-1 Infected Patients. 44th ICAAC, Washington, DC, 30 October-2 November 2004. Abstr. H-558 |
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| Oakland |
| California |
| 94602 |
| 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 Beach | Florida | 33140 | United States |
| GSK Investigational Site | Orlando | Florida | 32804 | United States |
| GSK Investigational Site | Orlando | Florida | 32806 | United States |
| GSK Investigational Site | Plantation | Florida | 33317 | United States |
| GSK Investigational Site | Tampa | Florida | 33602 | United States |
| GSK Investigational Site | Atlanta | Georgia | 30308/30309 | United States |
| GSK Investigational Site | Atlanta | Georgia | 30308 | United States |
| GSK Investigational Site | Atlanta | Georgia | 30339 | United States |
| GSK Investigational Site | Augusta | Georgia | 30912 | United States |
| GSK Investigational Site | Indianapolis | Indiana | 46202 | United States |
| GSK Investigational Site | New Orleans | Louisiana | 70115 | United States |
| GSK Investigational Site | St Louis | Missouri | 63108 | United States |
| GSK Investigational Site | Stony Brook | New York | 11794 | United States |
| GSK Investigational Site | The Bronx | New York | 10468 | United States |
| GSK Investigational Site | Charlotte | North Carolina | 28209 | United States |
| GSK Investigational Site | Akron | Ohio | 44304 | United States |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19102 | United States |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19131 | United States |
| GSK Investigational Site | Columbia | South Carolina | 29206-4713 | United States |
| GSK Investigational Site | Dallas | Texas | 75204 | United States |
| GSK Investigational Site | Dallas | Texas | 75208 | United States |
| GSK Investigational Site | Hampton | Virginia | 23666 | United States |
| GSK Investigational Site | Seattle | Washington | 98104 | United States |
| GSK Investigational Site | Brussels | 1000 | Belgium |
| GSK Investigational Site | Leuven | 3000 | Belgium |
| GSK Investigational Site | LiĂšge | 4000 | Belgium |
| GSK Investigational Site | Vancouver | British Columbia | V6Z 1Y6 | Canada |
| GSK Investigational Site | Ottawa | Ontario | K1N 6N5 | Canada |
| GSK Investigational Site | Toronto | Ontario | M4N 3M5 | Canada |
| GSK Investigational Site | Toronto | Ontario | M5B 1W8 | Canada |
| GSK Investigational Site | Toronto | Ontario | M5G 2C4 | Canada |
| GSK Investigational Site | Montreal | Quebec | H2L 4P9 | Canada |
| GSK Investigational Site | Montreal | Quebec | H2L 5B1 | Canada |
| GSK Investigational Site | Sainte-Foy | Quebec | G1V 4G2 | Canada |
| GSK Investigational Site | Garches | 92380 | France |
| GSK Investigational Site | Le Kremlin-BicĂȘtre | 94275 | France |
| GSK Investigational Site | Levallois-Perret | 92300 | France |
| GSK Investigational Site | Lyon | 69437 | France |
| GSK Investigational Site | Paris | 75651 | France |
| GSK Investigational Site | Munich | Bavaria | 80335 | Germany |
| GSK Investigational Site | Frankfurt am Main | Hesse | 60590 | Germany |
| GSK Investigational Site | Hanover | Lower Saxony | 30159 | Germany |
| GSK Investigational Site | Hanover | Lower Saxony | 30625 | Germany |
| GSK Investigational Site | Hamburg | 20099 | Germany |
| GSK Investigational Site | Ferrara | Emilia-Romagna | 44100 | Italy |
| GSK Investigational Site | Modena | Emilia-Romagna | 41100 | Italy |
| GSK Investigational Site | Brescia | Lombardy | 25125 | Italy |
| GSK Investigational Site | Milan | Lombardy | 20157 | Italy |
| GSK Investigational Site | Turin | Piedmont | 10149 | Italy |
| GSK Investigational Site | Verona | Veneto | 37135 | Italy |
| GSK Investigational Site | Braga | 4700-308 | Portugal |
| GSK Investigational Site | Cascais | 2750 | Portugal |
| GSK Investigational Site | Coimbra | 3000-075 | Portugal |
| GSK Investigational Site | Faro | 8000-386 | Portugal |
| GSK Investigational Site | Lisbon | 1769-001 | Portugal |
| GSK Investigational Site | Lisbon | Portugal |
| GSK Investigational Site | Barcelona | 08036 | Spain |
| GSK Investigational Site | Barcelona | 8400 | Spain |
| GSK Investigational Site | Elche (Alicante) | 03202 | Spain |
| GSK Investigational Site | Madrid | 28040 | Spain |
| GSK Investigational Site | Madrid | 28047 | Spain |
| GSK Investigational Site | Marbella | 29600 | Spain |
| GSK Investigational Site | Manchester | Lancashire | M8 5RB | United Kingdom |
| GSK Investigational Site | Thornton Heath | Surrey | CR7 7YE | United Kingdom |
| GSK Investigational Site | London | NW3 2QG | United Kingdom |
| GSK Investigational Site | London | SE5 9RS | United Kingdom |
| GSK Investigational Site | London | SW10 9TH | United Kingdom |
| GSK Investigational Site | London | SW17 0QT | United Kingdom |
| GSK Investigational Site | London | W2 1NY | United Kingdom |
| ID | Term |
|---|---|
| D007239 | Infections |
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| 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 |
|---|---|
| C492871 | abacavir, lamivudine drug combination |
| C106538 | abacavir |
| D019259 | Lamivudine |
| D000068698 | Tenofovir |
| 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 |
| 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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