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The purpose of this study is to compare long-term safety and tolerability of stavudine (d4T) extended release (ER) versus conventional (immediate release [IR]) formulations, each in combination with lamivudine (3TC) and efavirenz (EFV) in subjects who have completed Bristol-Myers Squibb (BMS) studies AI455-096 and AI455-099.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| stavudine, efavirenz, lamivudine | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Frequency and severity of AEs, and treatment discontinuations for AEs; population trends for triglycerides and cholesterol. Primary efficacy outcome: proportion of subjects with HIVRNA <400, <50, and change in viral load over the study period |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy: Changes in CD4 cell counts |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Berkeley | California | United States | |||
| Local Institution |
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| Los Angeles |
| California |
| United States |
| Local Institution | West Hollywood | California | United States |
| Local Institution | Washington D.C. | District of Columbia | United States |
| Local Institution | Fort Lauderdale | Florida | United States |
| Local Institution | Orlando | Florida | United States |
| Local Institution | Tampa | Florida | United States |
| Local Institution | Indianapolis | Indiana | United States |
| Local Institution | Wichita | Kansas | United States |
| Local Institution | Louisville | Kentucky | United States |
| Local Institution | Brookline | Massachusetts | United States |
| Local Institution | Las Vegas | Nevada | United States |
| Local Institution | Reno | Nevada | United States |
| Local Institution | New York | New York | United States |
| Local Institution | Winston-Salem | North Carolina | United States |
| Local Institution | Oklahoma City | Oklahoma | United States |
| Local Institution | Dallas | Texas | United States |
| Local Institution | Houston | Texas | United States |
| Local Institution | Hampton | Virginia | United States |
| Local Institution | San Isidro | Buenos Aires | Argentina |
| Local Institution | Rosario | Santa Fe Province | Argentina |
| Local Institution | Buenos Aires | Argentina |
| Local Institution | Córdoba | Argentina |
| Local Institution | Ghent | Belgium |
| Local Institution | Liège | Belgium |
| Local Institution | Salvador | Estado de Bahia | Brazil |
| Local Institution | Belo Horizonte - MG | Minas Gerais | Brazil |
| Local Institution | Botucatu | São Paulo | Brazil |
| Local Institution | Santos | São Paulo | Brazil |
| Local Institution | Vancouver | British Columbia | Canada |
| Local Institution | Toronto | Ontario | Canada |
| Local Institution | Montreal | Quebec | Canada |
| Local Institution | Bordeaux | France |
| Local Institution | Lyon | France |
| Local Institution | Nantes | France |
| Local Institution | Paris | France |
| Local Institution | Rennes | France |
| Local Institution | Rehovot | Israel |
| Local Institution | Tel Hashorner | Israel |
| Local Institution | Bari | Italy |
| Local Institution | Bergamo | Italy |
| Local Institution | Florence | Italy |
| Local Institution | Milan | Italy |
| Local Institution | Naples | Italy |
| Local Institution | Pisa | Italy |
| Local Institution | Torino | Italy |
| Local Institution | Mexico City | Mexico City | Mexico |
| Local Institution | Coimbra | Portugal |
| Local Institution | Lisbon | Portugal |
| Local Institution | Cotto Laurel | Puerto Rico |
| Local Institution | San Juan | Puerto Rico |
| Local Institution | Moscow | Russia |
| Local Institution | Saint Petersburg | Russia |
| Local Institution | Singapore | Singapore |
| Local Institution | Bedford Gardens | Gauteng | South Africa |
| Local Institution | Hatfield | Gauteng | South Africa |
| Local Institution | Johannesburg | Gauteng | South Africa |
| Local Institution | Westdene | Gauteng | South Africa |
| Local Institution | Tygerberg | Western Cape | South Africa |
| Local Institution | Barcelona | Spain |
| Local Institution | Madrid | Spain |
| Local Institution | Bangkok | Thailand |
| Local Institution | Nontaburi | Thailand |
| 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 |
|---|---|
| D018119 | Stavudine |
| C098320 | efavirenz |
| D019259 | Lamivudine |
| ID | Term |
|---|---|
| D013936 | Thymidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D015224 | Dideoxynucleosides |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D016047 | Zalcitabine |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
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