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

Purpose

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.

Condition	Intervention	Phase
HIV-1	Drug: fosamprenavir/ritonavir (700mg/100mg BID) Drug: fosamprenavir/ritonavir (1400mg/100mg BID) Drug: fosamprenavir/lopinavir/ritonavir (1400mg/533mg/100mg BID)	Phase III

MedlinePlus related topics:

AIDS

Drug Information available for:

Ritonavir Lopinavir Fosamprenavir Fosamprenavir calcium Fosamprenavir sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

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

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

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 Outcome Measures:

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 ]

Estimated Enrollment:	150
Study Start Date:	March 2005

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00144833

Show 44 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators


Study Director:	GSK Clinical Trials, MD	GlaxoSmithKline

More Information

Study ID Numbers:	APV102002
First Received:	September 1, 2005
Last Updated:	November 9, 2007
ClinicalTrials.gov Identifier:	NCT00144833
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by GlaxoSmithKline:

Protease inhibitors-experienced HIV-1 infected patients

Highly-resistant HIV-1

Dual boosted Pis

fosamprenavir

lopinavir

Study placed in the following topic categories:

Fosamprenavir

Lopinavir

Ritonavir

HIV Infections

Acquired Immunodeficiency Syndrome

Additional relevant MeSH terms:

Anti-Infective Agents

HIV Protease Inhibitors

Anti-HIV Agents

Anti-Retroviral Agents

Molecular Mechanisms of Pharmacological Action

Therapeutic Uses

Enzyme Inhibitors

Antiviral Agents

Pharmacologic Actions

Protease Inhibitors

ClinicalTrials.gov processed this record on October 31, 2008

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00144833