Clinical trial NCT00144833: Open Label Study of 908/RTV in Combination With Other PIs for the Treatment of Multi PI-Experienced HIV Subjects
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: HIV-1
Keywords: Protease inhibitors-experienced HIV-1 infected patients
Highly-resistant HIV-1
Dual boosted Pis
fosamprenavir
lopinavir
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-09-05
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: 24 weeks
Secondary outcomes:
measure: 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.
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Darlinghurst
country: Australia
facility: GSK Clinical Trials Call Center
state: New South Wales
city: Carlton
country: Australia
facility: GSK Clinical Trials Call Center
state: Victoria
city: Brussels
country: Belgium
facility: GSK Clinical Trials Call Center
city: Vancouver
country: Canada
facility: GSK Clinical Trials Call Center
state: British Columbia
city: Hamilton
country: Canada
facility: GSK Clinical Trials Call Center
state: Ontario
city: Ottawa
country: Canada
facility: GSK Clinical Trials Call Center
state: Ontario
city: Toronto
country: Canada
facility: GSK Clinical Trials Call Center
state: Ontario
city: Toronto
country: Canada
facility: GSK Clinical Trials Call Center
state: Ontario
city: Montreal
country: Canada
facility: GSK Clinical Trials Call Center
state: Quebec
city: Montreal
country: Canada
facility: GSK Clinical Trials Call Center
state: Quebec
city: Saint-Foy
country: Canada
facility: GSK Clinical Trials Call Center
state: Quebec
city: Lagny sur Marne
country: France
facility: GSK Clinical Trials Call Center
city: Paris
country: France
facility: GSK Clinical Trials Call Center
city: Paris
country: France
facility: GSK Clinical Trials Call Center
city: Paris
country: France
facility: GSK Clinical Trials Call Centre
city: Saint Denis
country: France
facility: GSK Clinical Trials Call Center
city: Strasburg
country: France
facility: GSK Clinical Trials Call Center
city: Toulon
country: France
facility: GSK Clinical Trials Call Center
city: Vanouvre Les Nancy
country: France
facility: GSK Clinical Trials Call Center
city: Hamburg
country: Germany
facility: GSK Clinical Trials Call Center
city: Athens
country: Greece
facility: GSK Clinical Trials Call Center
city: Athens
country: Greece
facility: GSK Clinical Trials Call Center
city: Athens
country: Greece
facility: GSK Clinical Trials Call Center
city: Piraeus
country: Greece
facility: GSK Clinical Trials Call Center
city: Liguria
country: Italy
facility: GSK Clinical Trials Call Center
city: Lombardia
country: Italy
facility: GSK Clinical Trials Call Center
city: Romagna
country: Italy
facility: GSK Clinical Trials Call Center
city: Rome
country: Italy
facility: GSK Clinical Trials Call Center
city: Torino
country: Italy
facility: GSK Clinical Trials Call Centre
city: Toscana
country: Italy
facility: GSK Clinical Trials Call Center
city: Toscana
country: Italy
facility: GSK Clinical Trials Call Center
city: Veneto
country: Italy
facility: GSK Clinical Trials Call Center
city: Barcelona
country: Spain
facility: GSK Clinical Trials Call Center
city: Jerez de la Frontera
country: Spain
facility: GSK Clinical Trials Call Center
city: Madrid
country: Spain
facility: GSK Clinical Trials Call Center
city: Madrid
country: Spain
facility: GSK Clinical Trials Call Center
city: Madrid
country: Spain
facility: GSK Clinical Trials Call Center
city: Birmingham
country: United Kingdom
facility: GSK Clinical Trials call Center
city: Brighton
country: United Kingdom
facility: GSK Clinical Trials Call Center
city: London
country: United Kingdom
facility: GSK Clinical Trials Call Center
city: London
country: United Kingdom
facility: GSK Clinical Trials Call Center
city: London
country: United Kingdom
facility: GSK Clinical Trials Call Center
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials, MD
role: STUDY_DIRECTOR
References: