Confirm the safety of maraviroc when used as a component of combination antiretroviral therapy in HIV and Hepatitis co-infected patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
maraviroc 150 mg. p.o. b.i.d., darunavir 600 mg. p.o. b.i.d., ritonavir 100 mg. p.o. b.i.d., raltegravir 400 mg. p.o. b.i.d.
etravirine 200 mg. p.o. b.i.d., darunavir 600 mg. p.o. b.i.d., ritonavir 100 mg. p.o. b.i.d., raltegravir 400 mg. p.o. b.i.d.
Pfizer Investigational Site
Clearwater, Florida, United States
Pfizer Investigational Site
Orlando, Florida, United States
Percentage of subjects with Grade 3 and Grade 4 ALT test abnormalities associated with a change from baseline ALT ≥100 IU/L through Week 48.
Time frame: 48 weeks
Percentage of HCV treated subjects with Grade 3 and Grade 4 ALT test abnormalities associated with a change from baseline ALT ≥100 IU/L through 96.
Time frame: 48 weeks
Time to development of Grade 3 and Grade 4 ALT test abnormalities associated with a change from baseline ALT ≥100 IU/L.
Time frame: 96 weeks
Percentage of subjects with Hy's law abnormalities through Week 48.
Time frame: 48 weeks
Percentage of HCV treated subjects with Hy's law abnormalities through Week 96.
Time frame: 96 weeks
Change from baseline in mean Hepatitis C viral load through Week 48
Time frame: 48 weeks
Undetectable HCV viral load 24 weeks after stopping HCV treatment.
Time frame: 240 weeks
Percentage of subjects with HIV-1 RNA levels <48 copies/mL at Week 48.
Time frame: 48 weeks
Change from baseline in CD4+ cell count at Week 48.
Time frame: 48 weeks
Change from baseline in mean hepatitis B DNA through Week 48
Time frame: 48 Weeks
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Pfizer Investigational Site
Safety Harbor, Florida, United States
Pfizer Investigational Site
Wilton Manors, Florida, United States
Pfizer Investigational Site
Atlanta, Georgia, United States
Pfizer Investigational Site
Atlanta, Georgia, United States
Pfizer Investigational Site
New Orleans, Louisiana, United States
Pfizer Investigational Site
Worcester, Massachusetts, United States
Pfizer Investigational Site
Worcester, Massachusetts, United States
Pfizer Investigational Site
Mount Vernon, New York, United States
...and 8 more locations