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Antiretroviral Therapy (ART) naive subjects will be enrolled in this clinical research study to test the safety and tolerability of fosamprenavir with or without ritonavir in combination TRIZIVIR and COMBIVIR. Subjects will receive 24 weeks of therapy.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fosamprenavir | Drug | |||
| COMBIVIR | Drug | |||
| ritonavir | Drug | |||
| TRIZIVIR | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the overall short term tolerance of the regimens under investigation |
| Measure | Description | Time Frame |
|---|---|---|
| Nature and incidence of laboratory abnormality; impact/burden of adverse events to subjects; plasma zidovudine (ZDV)pharmacokinetic parameters; change from baseline in plasma HIV-1 RNA levels over time. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trial, MD | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Clinical Trials Call Center | Little Rock | Arkansas | 72205 | United States | ||
| GSK Clinical Trials Call Center |
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| Long Beach |
| California |
| 90813 |
| United States |
| GSK Clinical Trials Call Center | Newport Beach | California | 92663 | United States |
| GSK Clinical Trials Call Center | San Diego | California | 92101 | United States |
| GSK Clinical Trials Call Center | Denver | Colorado | 80220 | United States |
| GSK Clinical Trials Call Center | Washington D.C. | District of Columbia | 20036 | United States |
| GSK Clinical Trials Call Center | Altamonte Springs | Florida | 32701 | United States |
| GSK Clinical Trials Call Center | Fort Lauderdale | Florida | 33308 | United States |
| GSK Clinical Trials Call Center | Fort Lauderdale | Florida | 33316 | United States |
| GSK Clinical Trials Call Center | Fort Lauderdale | Florida | 33334 | United States |
| GSK Clinical Trials Call Center | Atlanta | Georgia | 30339 | United States |
| GSK Clinical Trials Call Center | Greenville | North Carolina | 27858 | United States |
| GSK Clinical Trials Call Center | Philadelphia | Pennsylvania | 19107 | United States |
| GSK Clinical Trials Call Center | Lyon | 69437 | France |
| GSK Clinical Trials Call Center | Paris | 75475 | France |
| GSK Clinical Trials Call Center | Paris | 75679 | France |
| GSK Clinical Trials Call Center | London | SE5 9RS | United Kingdom |
| GSK Clinical Trials Call Center | Manchester | M8 6RL | United Kingdom |
| 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 |
|---|---|
| C426859 | fosamprenavir |
| C109078 | lamivudine, zidovudine drug combination |
| D019438 | Ritonavir |
| C418262 | abacavir, lamivudine, and zidovudine drug combination |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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