Open Label Study of 908/RTV in Combination With Other PIs for the Treatment of Multi PI-Experienced HIV Subjects

Phase 3TerminatedNCT00144833

GlaxoSmithKline150 enrolled

Overview

For HIV-infected individuals with highly resistant viruses, higher drug levels may be required to block the virus. This study investigates that concept by comparing the efficacy of standard fosamprenavir/ritonavir to an increased dose of boosted fosamprenavir and to a combination of fosamprenavir (increased dose)/lopinavir/ritonavir.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

150

Conditions

HIV-1

Interventions

fosamprenavir/ritonavir (700mg/100mg BID)DRUG

fosamprenavir/ritonavir (1400mg/100mg BID)DRUG

fosamprenavir/lopinavir/ritonavir (1400mg/533mg/100mg BID)DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion criteria: * Multiple protease-inhibitors experienced HIV-1 infected individuals experiencing virological failure and who's virus is not fully resistant to boosted fosamprenavir and boosted lopinavir based on genotypic resistance tests. Exclusion criteria: * No full resistance to FPV/r or LPV/r * Planned use of NNRTIs as part of the study salvage regimen * Application of additional exclusion criteria as determined by physician.

Locations (42)

Outcomes

Primary Outcomes

The average area under the curve minus baseline [AAUCMB] in plasma HIV-1 RNA at 24 Weeks when each are administered in combination with an optimised background therapy, in a multiple PI-experienced population experiencing virological failure.

Time frame: 24 weeks

Secondary Outcomes

Efficacy (AAUCMB) at 48 weeks, safety, tolerability(incidence and nature of AEs and laboratory abnormalities) at week 24 and 48, CD4 change from baseline at week 24 and 48, and the steady-state plasma APV and LPV through concentrations.

Time frame: 48 weeks

Data from ClinicalTrials.gov

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