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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
314
Fosamprenavir
Percentage of subjects with HIV-1 RNA less than 400 copies/mL
Time frame: Week 24
Percentage of subjects with plasma HIV-1 RNA <400 copies/mL
Time frame: Week 48
Percentage of subjects with plasma HIV-1 RNA <50 copies/mL at Week 24
Time frame: Week 24
Percentage of subjects with plasma HIV-1 RNA <50 copies/mL at Week 48
Time frame: Week 48
Number of subjects with any adverse events (AEs)
Time frame: up to Week 48
Number of subjects with gastrointestinal (GI) AEs
Time frame: up to Week 48
Absolute values of plasma HIV-1 RNA at Week 24
Time frame: Week 24
Median change from Baseline in HIV-1 RNA at Week 24
Time frame: Baseline and Week 24
Absolute values of plasma HIV-1 RNA at Week 48
Time frame: Week 48
Median change from Baseline in HIV-1 RNA at Week 48
Time frame: Baseline and Week 48
Absolute values in Cluster of Differentiation 4+ (CD4+) Cell Counts at Week 24
Time frame: Week 24
Absolute values in Cluster of Differentiation 4+ (CD4+) Cell Counts at Week 48
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GSK Investigational Site
Beverly Hills, California, United States
GSK Investigational Site
Fresno, California, United States
GSK Investigational Site
Laguna Beach, California, United States
GSK Investigational Site
Long Beach, California, United States
GSK Investigational Site
Los Angeles, California, United States
GSK Investigational Site
Tarzana, California, United States
GSK Investigational Site
Denver, Colorado, United States
GSK Investigational Site
Fort Collins, Colorado, United States
GSK Investigational Site
Washington D.C., District of Columbia, United States
GSK Investigational Site
Fort Lauderdale, Florida, United States
...and 42 more locations
Time frame: Week 48
Median change from Baseline in Cluster of Differentiation 4+ (CD4+) Cell Counts at Week 24
Time frame: Baseline and Week 24
Median change from Baseline in Cluster of Differentiation 4+ (CD4+) Cell Counts at Week 48
Time frame: Baseline and Week 48
Number of subjects with genotypic resistance at virologic failure
Time frame: up to Week 48
Number of subjects with phenotypic resistance at virologic failure
Time frame: up to Week 48
Time to loss of virologic response (TLOVR)
Time frame: up to Week 48
Medication adherence at Week 24
Time frame: Week 24
Medication adherence at Week 48
Time frame: Week 48
Subject treatment satisfaction per the HIV Treatment Satisfaction Questionnaire at Week 24
Time frame: Week 24
Subject treatment satisfaction per the HIV Treatment Satisfaction Questionnaire at Week 48
Time frame: Week 48