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

HIV-1 Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00144833
• Other study ID #: APV102002
• Status: Terminated
• Phase: Phase 3
• First received: September 1, 2005
• Last updated: November 9, 2007
• Start date: March 2005

Study information

• Verified date: November 2007
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 150
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV-1

Intervention

Drug:
• fosamprenavir/ritonavir (700mg/100mg BID)

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

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

Locations

Country	Name	City	State
Australia	GSK Clinical Trials Call Center	Carlton	Victoria
Australia	GSK Clinical Trials Call Center	Darlinghurst	New South Wales
Belgium	GSK Clinical Trials Call Center	Brussels
Canada	GSK Clinical Trials Call Center	Hamilton	Ontario
Canada	GSK Clinical Trials Call Center	Montreal	Quebec
Canada	GSK Clinical Trials Call Center	Montreal	Quebec
Canada	GSK Clinical Trials Call Center	Ottawa	Ontario
Canada	GSK Clinical Trials Call Center	Saint-Foy	Quebec
Canada	GSK Clinical Trials Call Center	Toronto	Ontario
Canada	GSK Clinical Trials Call Center	Toronto	Ontario
Canada	GSK Clinical Trials Call Center	Vancouver	British Columbia
France	GSK Clinical Trials Call Center	Lagny sur Marne
France	GSK Clinical Trials Call Center	Paris
France	GSK Clinical Trials Call Center	Paris
France	GSK Clinical Trials Call Centre	Paris
France	GSK Clinical Trials Call Center	Saint Denis
France	GSK Clinical Trials Call Center	Strasburg
France	GSK Clinical Trials Call Center	Toulon
France	GSK Clinical Trials Call Center	Vanouvre Les Nancy
Germany	GSK Clinical Trials Call Center	Hamburg
Greece	GSK Clinical Trials Call Center	Athens
Greece	GSK Clinical Trials Call Center	Athens
Greece	GSK Clinical Trials Call Center	Athens
Greece	GSK Clinical Trials Call Center	Piraeus
Italy	GSK Clinical Trials Call Center	Liguria
Italy	GSK Clinical Trials Call Center	Lombardia
Italy	GSK Clinical Trials Call Center	Romagna
Italy	GSK Clinical Trials Call Center	Rome
Italy	GSK Clinical Trials Call Centre	Torino
Italy	GSK Clinical Trials Call Center	Toscana
Italy	GSK Clinical Trials Call Center	Toscana
Italy	GSK Clinical Trials Call Center	Veneto
Spain	GSK Clinical Trials Call Center	Barcelona
Spain	GSK Clinical Trials Call Center	Jerez de la Frontera
Spain	GSK Clinical Trials Call Center	Madrid
Spain	GSK Clinical Trials Call Center	Madrid
Spain	GSK Clinical Trials Call Center	Madrid
United Kingdom	GSK Clinical Trials call Center	Birmingham
United Kingdom	GSK Clinical Trials Call Center	Brighton
United Kingdom	GSK Clinical Trials Call Center	London
United Kingdom	GSK Clinical Trials Call Center	London
United Kingdom	GSK Clinical Trials Call Center	London

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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