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

This study has been terminated.
(Incomplete data)
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00144833
First received: September 1, 2005
Last updated: November 9, 2007
Last verified: November 2007
  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 3

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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Hide Study Locations
Locations
Australia, New South Wales
GSK Clinical Trials Call Center
Darlinghurst, New South Wales, Australia, 2010
Australia, Victoria
GSK Clinical Trials Call Center
Carlton, Victoria, Australia, 3053
Belgium
GSK Clinical Trials Call Center
Brussels, Belgium, 1000
Canada, British Columbia
GSK Clinical Trials Call Center
Vancouver, British Columbia, Canada, V6Z 2C7
Canada, Ontario
GSK Clinical Trials Call Center
Hamilton, Ontario, Canada, L8N 3Z5
GSK Clinical Trials Call Center
Ottawa, Ontario, Canada, K1N 6N5
GSK Clinical Trials Call Center
Toronto, Ontario, Canada, M5B 1L6
GSK Clinical Trials Call Center
Toronto, Ontario, Canada, M4T 3A7
Canada, Quebec
GSK Clinical Trials Call Center
Montreal, Quebec, Canada, H2L 5B1
GSK Clinical Trials Call Center
Montreal, Quebec, Canada, H3G 1A4
GSK Clinical Trials Call Center
Saint-Foy, Quebec, Canada, G1V 4G2
France
GSK Clinical Trials Call Center
Lagny sur Marne, France, 77400
GSK Clinical Trials Call Center
Paris, France, 75970
GSK Clinical Trials Call Center
Paris, France, 75475
GSK Clinical Trials Call Centre
Paris, France, 93009
GSK Clinical Trials Call Center
Saint Denis, France, 93205
GSK Clinical Trials Call Center
Strasburg, France, 67000
GSK Clinical Trials Call Center
Toulon, France, 83000
GSK Clinical Trials Call Center
Vanouvre Les Nancy, France, 54511
Germany
GSK Clinical Trials Call Center
Hamburg, Germany, 20095
Greece
GSK Clinical Trials Call Center
Athens, Greece, 10676
GSK Clinical Trials Call Center
Athens, Greece, 11527
GSK Clinical Trials Call Center
Athens, Greece, 11526
GSK Clinical Trials Call Center
Piraeus, Greece, 18536
Italy
GSK Clinical Trials Call Center
Liguria, Italy, 16128
GSK Clinical Trials Call Center
Lombardia, Italy, 27100
GSK Clinical Trials Call Center
Romagna, Italy, 44100
GSK Clinical Trials Call Center
Rome, Italy, 00 168
GSK Clinical Trials Call Centre
Torino, Italy, 10149
GSK Clinical Trials Call Center
Toscana, Italy, 50139
GSK Clinical Trials Call Center
Toscana, Italy, 50126
GSK Clinical Trials Call Center
Veneto, Italy, 35128
Spain
GSK Clinical Trials Call Center
Barcelona, Spain, 8025
GSK Clinical Trials Call Center
Jerez de la Frontera, Spain, 11407
GSK Clinical Trials Call Center
Madrid, Spain, 28029
GSK Clinical Trials Call Center
Madrid, Spain, 28040
GSK Clinical Trials Call Center
Madrid, Spain, 28041
United Kingdom
GSK Clinical Trials call Center
Birmingham, United Kingdom, B29 JD6
GSK Clinical Trials Call Center
Brighton, United Kingdom, BN2 3EW
GSK Clinical Trials Call Center
London, United Kingdom, SE5 9RS
GSK Clinical Trials Call Center
London, United Kingdom, NW3 2QG
GSK Clinical Trials Call Center
London, United Kingdom, EC1A 7BE
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00144833     History of Changes
Other Study ID Numbers: APV102002
Study First Received: September 1, 2005
Last Updated: November 9, 2007
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

Additional relevant MeSH terms:
Protease Inhibitors
Ritonavir
Lopinavir
Fosamprenavir
HIV Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 01, 2014