The purpose of this study is to evaluate clinical response and safety of a Kaletra containing antiretroviral treatment regimen in HIV positive subjects with HCV coinfection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
86
400 mg/ 100 mg BID. Both arms use Kaletra 400/100 mg BID, plus NRTI chosen by the investigator
Site Reference ID/Investigator# 4118
Bayamón, Puerto Rico
Site Reference ID/Investigator# 4119
Bayamón, Puerto Rico
Site Reference ID/Investigator# 6298
Juana Diaz, Puerto Rico
Primary Outcome Measure
Changes in liver functions enzyme.
Time frame: Baseline, Week 4, Week 8, Week 16 and Week 24
Secondary Outcome Measures
Changes in HIV viral load, CD4/CD8 cell count, and Hepatitis C viral load
Time frame: Baseline, Week 4, Week 8, Week 16 and Week 24
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Site Reference ID/Investigator# 6284
Las Piedras, Puerto Rico
Site Reference ID/Investigator# 4101
Mayagüez, Puerto Rico
Site Reference ID/Investigator# 4116
Playa de Ponce, Puerto Rico
Site Reference ID/Investigator# 4117
Ponce, Puerto Rico
Site Reference ID/Investigator# 4099
Ponce, Puerto Rico
Site Reference ID/Investigator# 4086
Rio Piedras, Puerto Rico
Site Reference ID/Investigator# 4080
San Juan, Puerto Rico
...and 1 more locations