This is a 48-week study to evaluate the safety and efficacy of a new tablet formulation containing two FDA-approved drugs in HIV-infected patients who have not received prior therapy. This tablet will be taken with one of two FDA-approved drugs as a once-daily regimen. Study physicians will evaluate subjects to determine if they have certain medical conditions, laboratory test values, medication use, or drug allergies that would exclude them from the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
345
Viral load response at 48 weeks
Time frame: 48 weeks
Safety and tolerability Viral load response at 24 weeks Change in T-cell count Resistance Pharmacokinetics
Time frame: 48 weeks
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GSK Investigational Site
Phoenix, Arizona, United States
GSK Investigational Site
Fountain Valley, California, United States
GSK Investigational Site
Los Angeles, California, United States
GSK Investigational Site
San Francisco, California, United States
GSK Investigational Site
Denver, Colorado, 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
Washington D.C., District of Columbia, United States
GSK Investigational Site
Washington D.C., District of Columbia, United States
...and 48 more locations