NCT01054586 - Fosamprenavir in Pts With Hepatic Impairment | Biotech Hunter

Enrollment

167

Participants

Timeline

Start Date

January 31, 2009

Primary Completion Date

March 31, 2012

Study Completion Date

March 31, 2012

Conditions

Infection, Human Immunodeficiency Virus

Interventions

DRUG

Intervention A Standard dose

HIV subjects with HBV or HCV co-infection but normal hepatic function, defined by receipt of FPV 700mg BID/RTV 100mg BID and a baseline AST-platelet ratio index (APRI) score of \<2.0.

DRUG

Intervention B Reduced Dose

HIV subjects with mild hepatic impairment, defined by receipt of the recommended reduced FPV/RTV dose (700mg BID/100mg QD).

DRUG

Intervention C

HIV subjects with moderate hepatic impairment, defined by receipt of FPV 450mg BID/RTV 100mg QD.

DRUG

Intervention D

HIV subjects receiving the standard dose of FPV/RTV despite evidence of abnormal hepatic function according to APRI score: HIV subjects with HBV or HCV co-infection, receipt of FPV 700mg BID/RTV 100mg BID and a baseline APRI score of ≥2.0.

DRUG

Intervention E

HIV subjects coinfected with HBV or HCV who have initiated standard doses of LPV 400mg/RTV 100mg and enrolled in the same cohorts as the FPV/RTV exposed subjects.