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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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This study was designed to evaluate and compare safety, tolerability of subjects who successfully suppress HIV-1 on their first PI regimen to those who switch to fosamprenavir. This is a 48-week study, where subjects who were assigned to be in their original PI-group have the option of switching to fosamprenavir on week 24. Prior to being assigned their treatment group, subjects had to be suppressed for at least three months. All subjects also take a background regimen of two nucleoside/nucleotide reverse transcriptase inhibitors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm A | Experimental | Subjects switched their baseline PI for fosamprenavir (± ritonavir) while maintaining their baseline regimen of two nucleoside or nucleotide reverse transcriptase inhibitors for 48 weeks. |
|
| Treatment Arm B | Experimental | Subjects continued baseline regimen for first 24 weeks with the option of switching their initial PI for fosamprenavir (± ritonavir) while maintaining their baseline nucleoside or nucleotide reverse transcriptase inhibitor regimen for another 24 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fosamprenavir | Drug | Fosamprenavir |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects with HIV-1 RNA less than 400 copies/mL | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects with plasma HIV-1 RNA <400 copies/mL | Week 48 | |
| Percentage of subjects with plasma HIV-1 RNA <50 copies/mL at Week 24 | Week 24 | |
| Percentage of subjects with plasma HIV-1 RNA <50 copies/mL at Week 48 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | ViiV Healthcare | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Beverly Hills | California | 90210 | United States | ||
| GSK Investigational Site |
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| Week 48 |
| Number of subjects with any adverse events (AEs) | up to Week 48 |
| Number of subjects with gastrointestinal (GI) AEs | up to Week 48 |
| Absolute values of plasma HIV-1 RNA at Week 24 | Week 24 |
| Median change from Baseline in HIV-1 RNA at Week 24 | Baseline and Week 24 |
| Absolute values of plasma HIV-1 RNA at Week 48 | Week 48 |
| Median change from Baseline in HIV-1 RNA at Week 48 | Baseline and Week 48 |
| Absolute values in Cluster of Differentiation 4+ (CD4+) Cell Counts at Week 24 | Week 24 |
| Absolute values in Cluster of Differentiation 4+ (CD4+) Cell Counts at Week 48 | Week 48 |
| Median change from Baseline in Cluster of Differentiation 4+ (CD4+) Cell Counts at Week 24 | Baseline and Week 24 |
| Median change from Baseline in Cluster of Differentiation 4+ (CD4+) Cell Counts at Week 48 | Baseline and Week 48 |
| Number of subjects with genotypic resistance at virologic failure | up to Week 48 |
| Number of subjects with phenotypic resistance at virologic failure | up to Week 48 |
| Time to loss of virologic response (TLOVR) | up to Week 48 |
| Medication adherence at Week 24 | Week 24 |
| Medication adherence at Week 48 | Week 48 |
| Subject treatment satisfaction per the HIV Treatment Satisfaction Questionnaire at Week 24 | Week 24 |
| Subject treatment satisfaction per the HIV Treatment Satisfaction Questionnaire at Week 48 | Week 48 |
| Fresno |
| California |
| 93720 |
| United States |
| GSK Investigational Site | Laguna Beach | California | 90803 | United States |
| GSK Investigational Site | Long Beach | California | 90813 | United States |
| GSK Investigational Site | Los Angeles | California | 90069 | United States |
| GSK Investigational Site | Tarzana | California | 91356 | 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 | 20037 | United States |
| GSK Investigational Site | Fort Lauderdale | Florida | 33145 | United States |
| GSK Investigational Site | Fort Lauderdale | Florida | 33306 | United States |
| GSK Investigational Site | Fort Lauderdale | Florida | 33308 | United States |
| GSK Investigational Site | Fort Myers | Florida | 33901 | United States |
| GSK Investigational Site | Jacksonville | Florida | 32206 | United States |
| GSK Investigational Site | Miami | Florida | 33136 | United States |
| GSK Investigational Site | Orlando | Florida | 32804 | United States |
| GSK Investigational Site | Plantation | Florida | 33317 | United States |
| GSK Investigational Site | Tampa | Florida | 33614 | United States |
| GSK Investigational Site | West Palm Beach | Florida | 33408 | United States |
| GSK Investigational Site | Atlanta | Georgia | 30339 | United States |
| GSK Investigational Site | Augusta | Georgia | 30912 | United States |
| GSK Investigational Site | Des Moines | Iowa | 50309-1426 | United States |
| GSK Investigational Site | Wichita | Kansas | 67214 | United States |
| GSK Investigational Site | Lexington | Kentucky | 40536 | United States |
| GSK Investigational Site | Louisville | Kentucky | 40202 | United States |
| GSK Investigational Site | New Orleans | Louisiana | 70115 | United States |
| GSK Investigational Site | New Orleans | Louisiana | 70121 | United States |
| GSK Investigational Site | Shreveport | Louisiana | 71103 | United States |
| GSK Investigational Site | Detroit | Michigan | 48202 | United States |
| GSK Investigational Site | Jackson | Mississippi | 39202 | United States |
| GSK Investigational Site | Hillsborough | New Jersey | 08844 | United States |
| GSK Investigational Site | Somers Point | New Jersey | 08244 | United States |
| GSK Investigational Site | Brooklyn | New York | 11212 | United States |
| GSK Investigational Site | New York | New York | 10014 | United States |
| GSK Investigational Site | Rochester | New York | 14604 | United States |
| GSK Investigational Site | Valhalla | New York | 10595 | United States |
| GSK Investigational Site | Charlotte | North Carolina | 28209 | United States |
| GSK Investigational Site | Charlotte | North Carolina | 28211 | United States |
| GSK Investigational Site | Akron | Ohio | 44304 | United States |
| GSK Investigational Site | Oklahoma City | Oklahoma | 73104 | United States |
| GSK Investigational Site | Tulsa | Oklahoma | 74129 | United States |
| GSK Investigational Site | Allentown | Pennsylvania | 18103 | United States |
| GSK Investigational Site | Columbia | South Carolina | 29206-4713 | United States |
| GSK Investigational Site | Morristown | Tennessee | 37813 | 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 | 77027 | United States |
| GSK Investigational Site | Houston | Texas | 77098 | United States |
| GSK Investigational Site | Longview | Texas | 75604 | United States |
| GSK Investigational Site | Hampton | Virginia | 23666 | United States |
| GSK Investigational Site | Ponce | 731 | Puerto Rico |
| ID | Term |
|---|---|
| D007239 | Infections |
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| ID | Term |
|---|---|
| C426859 | fosamprenavir |
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