Observational Study Of A Protease Inhibitor (PI) Containing Regimen In Subjects With PI Mutations Selected During Prior Treatment With GW433908 (Fosamprenavir)

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: NCT00242840
Recruitment Status : Completed
First Posted : October 21, 2005
Last Update Posted : May 30, 2017
Information provided by (Responsible Party):
ViiV Healthcare

Brief Summary:
This study will assess the efficacy of subsequent protease inhibitor (PI)-containing therapy in subjects who have acquired HIV-1 protease mutations whilst receiving a GW433908 (fosamprenavir)-containing regimen.

Condition or disease Intervention/treatment Phase
Infection, Human Immunodeficiency Virus I HIV Infection Drug: No intervention; Observational study Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Official Title: A 24 Week Phase IIIb/IV Single Arm Open Label Observational Study to Explore the Efficacy of Protease Inhibitors Given in Combination With Reverse Transcriptase Inhibitors to HIV-1 Infected Subjects With Protease Mutations Selected During Therapy With GW433908 Containing Antiretroviral Therapy
Study Start Date : June 2003
Actual Primary Completion Date : January 2006
Actual Study Completion Date : January 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria:

  • Prior participation in study APV30005 AND one of the following studies: APV30001, APV30002, AZL30006, APV30003.
  • Must be failing virologically (>1000 copies at two consecutive time-points) and have a screening genotype with evidence of at least one new APV-associated protease mutation: V32I (+/- I47V), I50V, I54L/M, I84V acquired since commencing treatment with GW433908.

Exclusion criteria:

  • Have 2 or more of the primary resistance mutations D30N, G48V, V82A/F/T/S and L90M.
  • Have a medical need for use of an non-nucleoside reductase transferase inhibitor (NNRTI).
  • Have an acute CDC Class C event requiring therapeutic intervention.
  • Are pregnant or lactating.
  • Have any other condition which in the opinion of the investigator would preclude their participation.

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): NCT00242840

United States, Florida
GSK Investigational Site
Fort Lauderdale, Florida, United States, 33308
GSK Investigational Site
Orlando, Florida, United States, 32804
GSK Investigational Site
Tampa, Florida, United States, 33614
United States, Georgia
GSK Investigational Site
Atlanta, Georgia, United States, 30308/30309
GSK Investigational Site
Atlanta, Georgia, United States, 30308
GSK Investigational Site
Augusta, Georgia, United States, 30912
GSK Investigational Site
Brescia, Lombardia, Italy, 25125
Sponsors and Collaborators
ViiV Healthcare
Study Director: GSK Clinical Trials, MD GlaxoSmithKline

Responsible Party: ViiV Healthcare Identifier: NCT00242840     History of Changes
Other Study ID Numbers: APV30007
First Posted: October 21, 2005    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2017

Keywords provided by ViiV Healthcare:
protease inhibitor

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Communicable Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immune System Diseases
Slow Virus Diseases
Protease Inhibitors
HIV Protease Inhibitors
Reverse Transcriptase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Nucleic Acid Synthesis Inhibitors