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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00144833
Recruitment Status : Terminated (Incomplete data)
First Posted : September 5, 2005
Last Update Posted : November 12, 2007
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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.

Condition or disease Intervention/treatment 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  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : March 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Primary Outcome Measures :
  1. 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 :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00144833

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Sponsors and Collaborators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline Identifier: NCT00144833     History of Changes
Other Study ID Numbers: APV102002
First Posted: September 5, 2005    Key Record Dates
Last Update Posted: November 12, 2007
Last Verified: November 2007

Keywords provided by GlaxoSmithKline:
Protease inhibitors-experienced HIV-1 infected patients
Highly-resistant HIV-1
Dual boosted Pis

Additional relevant MeSH terms:
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors