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

A Phase III, Randomized, Controlled, Open-Label, Multicentre, Three Arm Study to Compare the Efficacy and Safety of a Dual-Boosted HIV-1 Protease Inhibitor Regimen of Fosamprenavir/Lopinavir/Ritonavir 1400mg/533mg/133mg Twice Daily and an Increased Dosage Regimen of FPV/RTV 1400mg/100mg BID Versus the Standard Dosage Regimen of FPV/RTV 700mg/100mg BID for 24 Weeks in Multiple-PI Experienced, HIV-Infected Adults Experiencing Virological Failure

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00144833

Enrollment

150

Registered

2005-09-05

Start date

2005-03-31

Completion date

Unknown

Last updated

2007-11-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV-1

Keywords

Protease inhibitors-experienced HIV-1 infected patients, Highly-resistant HIV-1, Dual boosted Pis, fosamprenavir, lopinavir

Brief summary

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.

Interventions

DRUGfosamprenavir/ritonavir (700mg/100mg BID)

DRUGfosamprenavir/ritonavir (1400mg/100mg BID)

DRUGfosamprenavir/lopinavir/ritonavir (1400mg/533mg/100mg BID)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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.	24 weeks

Secondary

Measure	Time frame
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.	48 weeks

Countries

Australia, Belgium, Canada, France, Germany, Greece, Italy, Spain, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026