This is a study to assess the response of lopinavir/ritonavir plus maraviroc (with no nucleoside medications) in HIV patients failing their initial antiviral therapy.
As long-term toxicity to many of the nucleoside medications have become known, interest has increased in treatment regimens that do not use these medications. This study is to assess the response of one such "nucleoside-sparing" therapy in patients who are showing failure to their initial nucleoside-containing treatment regimen.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
3
lopinavir/ritonavir 400/100 mg bid plus maraviroc 150 mg bid
Barry M. Rodwick, M. D.
Safety Harbor, Florida, United States
Virologic response defined as viral load reduction of >/= 1 log
Time frame: 48 weeks
Assess proportion of patients with HIV-1 viral load < 48 copies
Time frame: 48 weks
Assess time to loss of virologic response
Time frame: 48 weeks
Assess development of resistance mutations in patients who develop rebound
Time frame: 48 weeks
Compare serum lipid profile changes
Time frame: 48 weeks
Assess safety and tolerability
Time frame: 48 weeks
Assess degree of immune reconstitution
Time frame: 48 weeks
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