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| ID | Type | Description | Link |
|---|---|---|---|
| APV30002 |
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The purpose of this study is to compare virus response to GW433908/ritonavir (RTV) to viral response to nelfinavir (NFV) when used with abacavir (ABC)/lamivudine (3TC) in patients that have not taken antiretroviral (ART) drugs.
Patients are randomized to 1 of 2 treatment arms. One arm is treated with GW433908/RTV plus ABC and 3TC. The other is treated with NFV plus ABC and 3TC. Each group is treated for 48 weeks. The following are compared in the 2 arms: 1) magnitude and durability of antiviral response; 2) safety, tolerance, and antiviral response after 24 and 48 weeks of therapy; 3) time to treatment failure; 4) immunologic response; 5) occurrence of events related to metabolic abnormalities; and 6) development of viral resistance in a subset of patients following treatment. Also studied are: 1) steady-state plasma drug trough concentrations; 2) demographic, virologic, immunologic, pharmacologic, and adherence factors that may be associated with treatment outcome; 3) patient adherence to the drug regimens; 4) study medication utilization; and 5) resource utilization.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ritonavir | Drug | |||
| Abacavir sulfate | Drug | |||
| Nelfinavir mesylate | Drug | |||
| Lamivudine | Drug | |||
| GW433908 | Drug |
Inclusion Criteria
Patients may be eligible for this study if they:
Exclusion Criteria
Patients will not be eligible for this study if they:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orange County Ctr for Special Immunology | Fountain Valley | California | 92708 | United States | ||
| AIDS Healthcare Foundation |
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| Los Angeles |
| California |
| 90027 |
| United States |
| LAGLC | Los Angeles | California | 90028 | United States |
| Kaiser Hospital | Sacramento | California | 95825 | United States |
| Park Ctr for Health / Keith Vrhel | San Diego | California | 92103 | United States |
| AIDS Research Alliance | West Hollywood | California | 90069 | United States |
| Dupont Circle Physicians Group | Washington D.C. | District of Columbia | 200091104 | United States |
| Infectious Disease Consultants | Altamonte Springs | Florida | 32701 | United States |
| CRI of South Florida | Coral Gables | Florida | 33146 | United States |
| Therafirst Med Ctr | Fort Lauderdale | Florida | 33308 | United States |
| Gary Richmond MD | Fort Lauderdale | Florida | 33316 | United States |
| Univ of Miami Dept of Medicine | Miami | Florida | 33136 | United States |
| Specialty Med Care Ctrs of South Florida Inc | Miami | Florida | 33142 | United States |
| Infectious Diseases Associates | Sarasota | Florida | 34239 | United States |
| Jeffrey Levenson | St. Petersburg | Florida | 33710 | United States |
| Infectious Disease Research Inst | Tampa | Florida | 33614 | United States |
| AIDS Research Consortium of Atlanta | Atlanta | Georgia | 30308 | United States |
| Med College of Georgia | Augusta | Georgia | 30912 | United States |
| SMO USA | Conyers | Georgia | 30013 | United States |
| Indiana Univ Med School | Indianapolis | Indiana | 46202 | United States |
| Brigham and Women's Hosp | Boston | Massachusetts | 02115 | United States |
| Hawthorne Med Associates / PAACA | New Bedford | Massachusetts | 02745 | United States |
| Abbott-Northwestern Hosp / Clinic 42 | Minneapolis | Minnesota | 55404 | United States |
| Southampton Healthcare Inc | St Louis | Missouri | 63139 | United States |
| VAMC New Jersey Healthcare System | East Orange | New Jersey | 07018 | United States |
| North Jersey Community Research Initiative | Newark | New Jersey | 071032842 | United States |
| SUNY / Erie County Med Ctr at Buffalo | Buffalo | New York | 14215 | United States |
| North Shore Univ Hosp | Manhasset | New York | 11030 | United States |
| St Lukes - Roosevelt Hosp Ctr | New York | New York | 10019 | United States |
| Bronx Veterans Affairs Med Ctr | The Bronx | New York | 10468 | United States |
| Univ of Cincinnati / Holmes Hosp | Cincinnati | Ohio | 452670405 | United States |
| Milton S Hershey Med Ctr | Hershey | Pennsylvania | 170330850 | United States |
| Hahnemann Univ Hosp | Philadelphia | Pennsylvania | 19102 | United States |
| Burnside Clinic | Columbia | South Carolina | 29206 | United States |
| Methodist Healthcare | Memphis | Tennessee | 38104 | United States |
| Nicholas Bellos | Dallas | Texas | 75246 | United States |
| Joseph C Gathe | Houston | Texas | 77004 | 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 |
|---|---|
| D019438 | Ritonavir |
| C106538 | abacavir |
| D019888 | Nelfinavir |
| D019259 | Lamivudine |
| C426859 | fosamprenavir |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007546 | Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D016047 | Zalcitabine |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D015224 | Dideoxynucleosides |
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